The following data is part of a De Novo classification by Imagen Technologies, Inc. with the FDA for Osteodetect.
| DeNovo ID | DEN180005 |
| Device Name: | OsteoDetect |
| Classification | Radiological Computer Assisted Detection/diagnosis Software For Fracture |
| Applicant | Imagen Technologies, Inc. 33 East 33rd Street, Suite 506 New York, NY 10016 |
| Contact | Alex Dresner |
| Product Code | QBS |
| CFR Regulation Number | 892.2090 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Radiology |
| Classification Advisory | Radiology |
| Type | Direct |
| Date Received | 2018-02-05 |
| Decision Date | 2018-05-24 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |