STAGE 200003
GUDID 00866463000410
STAGE works as a comprehensive brain imaging post-processing solution. The STAGE system consists of a dedicated computer connected to the user’s local area network. The computer receives DICOM data from a specific MRI 3D GRE scan protocol (i.e. the STAGE protocol) and then outputs back numerous DICOM datasets with different types of contrast to wherever it received the files from (most likely a PACS server). The STAGE system will not contain any user interface. Instead, the data transfer will be initiated by the user’s current DICOM viewing software. The main method for user communication will be through DICOM output files that contain information in the image data. A method for remote connection to the STAGE computer will be included for updating and troubleshooting when an internet connection is available.
Spintech, Inc.
MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software| Primary Device ID | 00866463000410 |
| NIH Device Record Key | c18852fa-8a37-433d-bf7a-e48c1a4b9d49 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | STAGE |
| Version Model Number | 1.1 |
| Catalog Number | 200003 |
| Company DUNS | 105125594 |
| Company Name | Spintech, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | (248) 712-6789 |
| info@spintechmri.com | |
| Phone | (248) 712-6789 |
| info@spintechmri.com | |
| Phone | (248) 712-6789 |
| info@spintechmri.com | |
| Phone | (248) 712-6789 |
| info@spintechmri.com | |
| Phone | (248) 712-6789 |
| info@spintechmri.com | |
| Phone | (248) 712-6789 |
| info@spintechmri.com | |
| Phone | (248) 712-6789 |
| info@spintechmri.com | |
| Phone | (248) 712-6789 |
| info@spintechmri.com | |
| Phone | (248) 712-6789 |
| info@spintechmri.com | |
| Phone | (248) 712-6789 |
| info@spintechmri.com | |
| Phone | (248) 712-6789 |
| info@spintechmri.com | |
| Phone | (248) 712-6789 |
| info@spintechmri.com | |
| Phone | (248) 712-6789 |
| info@spintechmri.com | |
| Phone | (248) 712-6789 |
| info@spintechmri.com | |
| Phone | (248) 712-6789 |
| info@spintechmri.com | |
| Phone | (248) 712-6789 |
| info@spintechmri.com | |
| Phone | (248) 712-6789 |
| info@spintechmri.com | |
| Phone | (248) 712-6789 |
| info@spintechmri.com | |
| Phone | (248) 712-6789 |
| info@spintechmri.com | |
| Phone | (248) 712-6789 |
| info@spintechmri.com | |
| Phone | (248) 712-6789 |
| info@spintechmri.com | |
| Phone | (248) 712-6789 |
| info@spintechmri.com | |
| Phone | (248) 712-6789 |
| info@spintechmri.com | |
| Phone | (248) 712-6789 |
| info@spintechmri.com | |
| Phone | (248) 712-6789 |
| info@spintechmri.com | |
| Phone | (248) 712-6789 |
| info@spintechmri.com | |
| Phone | (248) 712-6789 |
| info@spintechmri.com | |
| Phone | (248) 712-6789 |
| info@spintechmri.com | |
| Phone | (248) 712-6789 |
| info@spintechmri.com | |
| Phone | (248) 712-6789 |
| info@spintechmri.com | |
| Phone | (248) 712-6789 |
| info@spintechmri.com | |
| Phone | (248) 712-6789 |
| info@spintechmri.com | |
| Phone | (248) 712-6789 |
| info@spintechmri.com | |
| Phone | (248) 712-6789 |
| info@spintechmri.com | |
| Phone | (248) 712-6789 |
| info@spintechmri.com | |
| Phone | (248) 712-6789 |
| info@spintechmri.com | |
| Phone | (248) 712-6789 |
| info@spintechmri.com | |
| Phone | (248) 712-6789 |
| info@spintechmri.com | |
| Phone | (248) 712-6789 |
| info@spintechmri.com | |
| Phone | (248) 712-6789 |
| info@spintechmri.com | |
| Phone | (248) 712-6789 |
| info@spintechmri.com | |
| Phone | (248) 712-6789 |
| info@spintechmri.com | |
| Phone | (248) 712-6789 |
| info@spintechmri.com | |
| Phone | (248) 712-6789 |
| info@spintechmri.com | |
| Phone | (248) 712-6789 |
| info@spintechmri.com | |
| Phone | (248) 712-6789 |
| info@spintechmri.com | |
| Phone | (248) 712-6789 |
| info@spintechmri.com | |
| Phone | (248) 712-6789 |
| info@spintechmri.com | |
| Phone | (248) 712-6789 |
| info@spintechmri.com | |
| Phone | (248) 712-6789 |
| info@spintechmri.com | |
| Phone | (248) 712-6789 |
| info@spintechmri.com | |
| Phone | (248) 712-6789 |
| info@spintechmri.com | |
| Phone | (248) 712-6789 |
| info@spintechmri.com | |
| Phone | (248) 712-6789 |
| info@spintechmri.com | |
| Phone | (248) 712-6789 |
| info@spintechmri.com | |
| Phone | (248) 712-6789 |
| info@spintechmri.com | |
| Phone | (248) 712-6789 |
| info@spintechmri.com | |
| Phone | (248) 712-6789 |
| info@spintechmri.com | |
| Phone | (248) 712-6789 |
| info@spintechmri.com | |
| Phone | (248) 712-6789 |
| info@spintechmri.com | |
| Phone | (248) 712-6789 |
| info@spintechmri.com | |
| Phone | (248) 712-6789 |
| info@spintechmri.com | |
| Phone | (248) 712-6789 |
| info@spintechmri.com | |
| Phone | (248) 712-6789 |
| info@spintechmri.com | |
| Phone | (248) 712-6789 |
| info@spintechmri.com | |
| Phone | (248) 712-6789 |
| info@spintechmri.com |
Operating and Storage Conditions
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00866463000410 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K210843
FDA Product Code
| LNH | System, Nuclear Magnetic Resonance Imaging |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-10-14 |
| Device Publish Date | 2021-10-06 |
On-Brand Devices [STAGE]
| 00866463000410 | STAGE works as a comprehensive brain imaging post-processing solution. The STAGE system consists |
| 00866463000441 | STAGE works as a comprehensive brain imaging post-processing solution. The STAGE system consists |
Trademark Results [STAGE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STAGE 98478741 not registered Live/Pending |
Belkin International, Inc. 2024-04-01 |
 STAGE 97215690 not registered Live/Pending |
Stage Technologies, Inc. 2022-01-12 |
 STAGE 90705487 not registered Live/Pending |
Virginia Carnesale 2021-05-12 |
 STAGE 90654086 not registered Live/Pending |
Virginia Carnesale 2021-04-19 |
 STAGE 88522570 not registered Live/Pending |
Cirkul, Inc. 2019-07-18 |
 STAGE 88302853 not registered Live/Pending |
Drew Layne, LLC 2019-02-15 |
 STAGE 87888324 5626952 Live/Registered |
Tower Of Quarters, Inc. 2018-04-23 |
 STAGE 87647540 not registered Dead/Abandoned |
DATA CENTER STANDARDS FOUNDATION 2017-10-16 |
 STAGE 87647528 not registered Dead/Abandoned |
DATA CENTER STANDARDS FOUNDATION 2017-10-16 |
 STAGE 87327783 not registered Dead/Abandoned |
Bubble, Inc. 2017-02-07 |
 STAGE 87213350 5231724 Live/Registered |
WLM Enterprises LLC 2016-10-24 |
 STAGE 86646005 5142482 Live/Registered |
Specialty Retailers, Inc. 2015-05-29 |
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