FractureDetect (FX)
510(k) K193417
FractureDetect (FX) is a medical device (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, 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 | NumberK193417 | Date30 Jul 2020 | StatusActive |
Official records
- FDA 510(k) database K193417
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- Withdrawn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 K193417
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 | |||
|---|---|---|---|---|
| FractureDetect (FX) 1.0.0 | 1.0.0 | 00852491008016 | — | On the market |
Similar devices
Other devices filed under FDA product code QBS (Radiological Computer Assisted Detection/Diagnosis Software For Fracture).