STAGE

GUDID 00866463000441

STAGE works as a comprehensive brain imaging post-processing solution. The STAGE system consists of a client supplied dedicated computer with an ethernet connection to the client’s existing local network. The STAGE software will operate within a virtual machine environment (virtual STAGE module) on this dedicated computer. 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 the PACS server. The data transfer is initiated by the user’s current DICOM viewing software. STAGE has been modified from the predicate to include CROWN, a white noise filtering algorithm intended to improve specific STAGE outputs. The following table provide a summary of the methodology for each output with an example image and technical comparison to the predicate.

Spintech, Inc.

MRI system application software

• Primary Device ID: 00866463000441
• NIH Device Record Key: 03e28d69-4eb2-4224-8df4-e8fac407cf8c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STAGE
• Version Model Number: 2
• 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: 2487126789
• Email: info@spintechmri.com
• Phone: 2487126789
• Email: info@spintechmri.com
• Phone: 2487126789
• Email: info@spintechmri.com
• Phone: 2487126789
• Email: info@spintechmri.com
• Phone: 2487126789
• Email: info@spintechmri.com
• Phone: 2487126789
• Email: info@spintechmri.com
• Phone: 2487126789
• Email: info@spintechmri.com
• Phone: 2487126789
• Email: info@spintechmri.com
• Phone: 2487126789
• Email: info@spintechmri.com
• Phone: 2487126789
• Email: info@spintechmri.com
• Phone: 2487126789
• Email: info@spintechmri.com
• Phone: 2487126789
• Email: info@spintechmri.com
• Phone: 2487126789
• Email: info@spintechmri.com
• Phone: 2487126789
• Email: info@spintechmri.com
• Phone: 2487126789
• Email: info@spintechmri.com
• Phone: 2487126789
• Email: info@spintechmri.com
• Phone: 2487126789
• Email: info@spintechmri.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00866463000441 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223079

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: 2023-03-03
• Device Publish Date: 2023-02-23

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