FractureDetect (FX) 1.0.0
FractureDetect (FX) 1.0.0 is a X-ray image interpretive software (FDA Class II; FDA product code QBS, Radiological Computer Assisted Detection/Diagnosis Software For Fracture) made by Imagen Technologies, Inc., cleared under FDA 510(k) K193417 on 30 Jul 2020 and listed in FDA GUDID since 12 Apr 2021 (UDI-DI 00852491008016), 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 | Number00852491008016 | Date12 Apr 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK193417 | Date30 Jul 2020 | StatusActive |
Official records
- AccessGUDID record 00852491008016
- FDA 510(k) database K193417
Across registries
- FDA 510(k) K193417 decided 30 Jul 2020 Active
- FDA GUDID UDI-DI 00852491008016 listed 12 Apr 2021 Listed
Timeline
- Cleared FDA 510(k) K193417
- Listed FDA GUDID 00852491008016
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- FractureDetect (FX)
- Generic name
- X-ray image interpretive software
- Model / reference
- 1.0.0
- Primary DI / UDI-DI
- 00852491008016
- 510(k) Number
- FDA product code
- QBS
- GMDN term
- X-ray image interpretive software
- Device class
- Class II
- Regulation number
- 892.2090
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code QBS (Radiological Computer Assisted Detection/Diagnosis Software For Fracture).