The following data is part of a premarket notification filed by Imagen Technologies, Inc. with the FDA for Fracturedetect (fx).
| Device ID | K193417 |
| 510k Number | K193417 |
| Device Name: | FractureDetect (FX) |
| Classification | Radiological Computer Assisted Detection/diagnosis Software For Fracture |
| Applicant | Imagen Technologies, Inc. WeWork, 524 Broadway, 8th Floor New York, NY 10012 |
| Contact | Robert Lindsey |
| Correspondent | Donna-bea Tillman Biologics Consulting 1555 King St, Suite 300 Alexandria, VA 22314 |
| Product Code | QBS |
| CFR Regulation Number | 892.2090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-09 |
| Decision Date | 2020-07-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852491008016 | K193417 | 000 |