icobrain mr 5.16
by icometrix NV
icobrain mr 5.16 is a medical device (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by icometrix NV, registered in EUDAMED and listed in FDA GUDID since 6 Aug 2024 (UDI-DI B621ICOBRAINMR5X16Y0), active as of 23 Oct 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | NumberB621ICOBRAINMR5X16Y0 | Date6 Aug 2024 | StatusListed |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Official records
Across registries
- EUDAMED Active
- FDA GUDID UDI-DI B621ICOBRAINMR5X16Y0 listed 6 Aug 2024 Listed
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- icobrain mr
- Generic name
- Radiology DICOM image processing application software
- Model / reference
- 5.16
- Primary DI / UDI-DI
- B621ICOBRAINMR5X16Y0
- FDA product code
- LLZ
- GMDN term
- Radiology DICOM image processing application software
- Device class
- Class II
- Regulation number
- 892.2050
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Safe
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