icobrain mr 5.15
by icometrix NV
icobrain mr 5.15 is a medical device (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by icometrix NV, listed in FDA GUDID since 29 May 2024 (UDI-DI B621ICOBRAINMR5X15Y0), registry data as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberB621ICOBRAINMR5X15Y0 | Date29 May 2024 | StatusListed |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- icobrain mr
- Generic name
- Radiology DICOM image processing application software
- Model / reference
- 5.15
- Primary DI / UDI-DI
- B621ICOBRAINMR5X15Y0
- 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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