icobrain aria 1.1
by icometrix NV
icobrain aria 1.1 is a medical device (FDA Class II; FDA product code QBS, Radiological Computer Assisted Detection/Diagnosis Software For Fracture) made by icometrix NV, cleared under FDA 510(k) K240712 on 7 Nov 2024 and listed in FDA GUDID since 18 Feb 2025 (UDI-DI B621ICOBRAINARIA1X1Y0), 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 | NumberB621ICOBRAINARIA1X1Y0 | Date18 Feb 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK240712 | Date7 Nov 2024 | StatusActive |
Official records
- FDA 510(k) database K240712
Across registries
- FDA 510(k) K240712 decided 7 Nov 2024 Active
- FDA GUDID UDI-DI B621ICOBRAINARIA1X1Y0 listed 18 Feb 2025 Listed
Timeline
- Cleared FDA 510(k) K240712
- Listed FDA GUDID B621ICOBRAINARIA1X1Y0
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- icobrain aria
- Generic name
- Radiology DICOM image processing application software
- Model / reference
- 1.1
- Primary DI / UDI-DI
- B621ICOBRAINARIA1X1Y0
- 510(k) Number
- FDA product code
- QBS
- GMDN term
- Radiology DICOM image processing application software
- Device class
- Class II
- Regulation number
- 892.2090
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Safe
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