CAREMIBRAIN FP-0600
GUDID 08437018413188
CareMiBrain is a Positron Emission Tomography system for brain imaging in neurological and oncological applications. It has two main parts: the detection and acquisition system and the Control Unit.
GENERAL EQUIPMENT FOR MEDICAL IMAGING SA
Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use| Primary Device ID | 08437018413188 |
| NIH Device Record Key | 9a25f03f-8d9b-446f-a390-e3c0ba7bc288 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CAREMIBRAIN |
| Version Model Number | FP-0600 |
| Catalog Number | FP-0600 |
| Company DUNS | 463337670 |
| Company Name | GENERAL EQUIPMENT FOR MEDICAL IMAGING SA |
| 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 | true |
| 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 |
Device Dimensions
| Height | 1776 Millimeter |
| Weight | 300 Kilogram |
| Width | 780 Millimeter |
| Depth | 203 Millimeter |
| Length | 2281 Millimeter |
| Height | 1776 Millimeter |
| Weight | 300 Kilogram |
| Width | 780 Millimeter |
| Depth | 203 Millimeter |
| Length | 2281 Millimeter |
| Height | 1776 Millimeter |
| Weight | 300 Kilogram |
| Width | 780 Millimeter |
| Depth | 203 Millimeter |
| Length | 2281 Millimeter |
| Height | 1776 Millimeter |
| Weight | 300 Kilogram |
| Width | 780 Millimeter |
| Depth | 203 Millimeter |
| Length | 2281 Millimeter |
| Height | 1776 Millimeter |
| Weight | 300 Kilogram |
| Width | 780 Millimeter |
| Depth | 203 Millimeter |
| Length | 2281 Millimeter |
| Height | 1776 Millimeter |
| Weight | 300 Kilogram |
| Width | 780 Millimeter |
| Depth | 203 Millimeter |
| Length | 2281 Millimeter |
| Height | 1776 Millimeter |
| Weight | 300 Kilogram |
| Width | 780 Millimeter |
| Depth | 203 Millimeter |
| Length | 2281 Millimeter |
| Height | 1776 Millimeter |
| Weight | 300 Kilogram |
| Width | 780 Millimeter |
| Depth | 203 Millimeter |
| Length | 2281 Millimeter |
| Height | 1776 Millimeter |
| Weight | 300 Kilogram |
| Width | 780 Millimeter |
| Depth | 203 Millimeter |
| Length | 2281 Millimeter |
| Height | 1776 Millimeter |
| Weight | 300 Kilogram |
| Width | 780 Millimeter |
| Depth | 203 Millimeter |
| Length | 2281 Millimeter |
| Height | 1776 Millimeter |
| Weight | 300 Kilogram |
| Width | 780 Millimeter |
| Depth | 203 Millimeter |
| Length | 2281 Millimeter |
| Height | 1776 Millimeter |
| Weight | 300 Kilogram |
| Width | 780 Millimeter |
| Depth | 203 Millimeter |
| Length | 2281 Millimeter |
Operating and Storage Conditions
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08437018413188 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K232569
FDA Product Code
| KPS | System, Tomography, Computed, Emission |
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 | 2024-06-05 |
| Device Publish Date | 2024-05-28 |
Devices Manufactured by GENERAL EQUIPMENT FOR MEDICAL IMAGING SA
| 08437018413188 - CAREMIBRAIN | 2024-06-05CareMiBrain is a Positron Emission Tomography system for brain imaging in neurological and oncological applications. It has two main parts: the detection and acquisition system and the Control Unit. |
| 08437018413188 - CAREMIBRAIN | 2024-06-05 CareMiBrain is a Positron Emission Tomography system for brain imaging in neurological and oncological applications. It has two |
| 08437018413010 - SENTINELLA | 2022-01-24 Sentinella 102 is a mobile gamma camera system which is intended for imaging the distribution of radionuclides in the human body |
| 08437018413027 - SENTINELLA | 2022-01-24 Sentinella 102 is a mobile gamma camera system which is intended for imaging the distribution of radionuclides in the human body |
| 08437018413034 - MAMMI | 2022-01-24 MAMMI is a Positron Emission Tomography (PET) system for medical imaging applications and for measuring the distribution of posi |
| 08437018413041 - MAMMI | 2022-01-24 MAMMI is a Positron Emission Tomography (PET) system for medical imaging applications and for measuring the distribution of posi |
| 08437018413072 - WPROBE | 2021-12-09 Wprobe is a wireless ionizing radiation detector probe for use in the medical environment. The instrument is optimized to detec |
| 08437018413089 - WPROBE | 2021-12-09 Wprobe is a wireless ionizing radiation detector probe for use in the medical environment. The instrument is optimized to detect |
| 08437018413096 - WPROBE | 2021-12-09 Wprobe is a wireless ionizing radiation detector probe for use in the medical environment. The instrument is optimized to detect |
Trademark Results [CAREMIBRAIN]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CAREMIBRAIN 79218664 5461510 Live/Registered |
General Equipment For Medical Imaging, S.A. 2017-05-30 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.