icobrain 2
by icometrix NV
icobrain 2 is a medical device (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by icometrix NV, cleared under FDA 510(k) K161148 on 9 Aug 2016 and listed in FDA GUDID since 29 Jan 2018 (UDI-DI B621ICOBRAIN20), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberB621ICOBRAIN20 | Date29 Jan 2018 | StatusListed |
| United States | FDA 510(k) | NumberK161148 | Date9 Aug 2016 | StatusActive |
Official records
- FDA 510(k) database K161148
Across registries
- FDA 510(k) K161148 decided 9 Aug 2016 Active
- FDA GUDID UDI-DI B621ICOBRAIN20 listed 29 Jan 2018 Listed
Timeline
- Cleared FDA 510(k) K161148
- Listed FDA GUDID B621ICOBRAIN20
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- icobrain
- Generic name
- Radiology DICOM image processing application software
- Model / reference
- 2
- Primary DI / UDI-DI
- B621ICOBRAIN20
- 510(k) Number
- 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
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