icobrain aria
by icometrix NV
510(k) K240712
icobrain aria 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, active as of 10 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK240712 | Date7 Nov 2024 | StatusActive |
Official records
- FDA 510(k) database K240712
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- QBS
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2090
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K240712
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| icobrain aria 1.1 | 1.1 | B621ICOBRAINARIA1X1Y0 | — | On the market |
| icobrain aria 1.2 | 1.2 | B621ICOBRAINARIA1X2Y0 | — | On the market |
Similar devices
Other devices filed under FDA product code QBS (Radiological Computer Assisted Detection/Diagnosis Software For Fracture).