ProFound AI 2.1
by Icad, Inc.
ProFound AI 2.1 is a Class II device made by Icad, Inc., cleared under FDA 510(k) K182373 on 6 Dec 2018 and listed in FDA GUDID since 11 Jul 2019 (UDI-DI 00858012005960), active as of 22 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 | Number00858012005960 | Date11 Jul 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK182373 | Date6 Dec 2018 | StatusActive |
Official records
- AccessGUDID record 00858012005960
- FDA 510(k) database K182373
Across registries
- FDA 510(k) K182373 decided 6 Dec 2018 Active
- FDA GUDID UDI-DI 00858012005960 listed 11 Jul 2019 Listed
Timeline
- Cleared FDA 510(k) K182373
- Listed FDA GUDID 00858012005960
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- ProFound AI
- Generic name
- Basic x-ray clinical assessment support software
- Model / reference
- 2.1
- Primary DI / UDI-DI
- 00858012005960
- 510(k) Number
- FDA product code
- QDQ
- GMDN term
- Basic x-ray clinical assessment support software
- Device class
- Class II
- Regulation number
- 892.2090
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Basic diagnostic x-ray system application software.