The following data is part of a De Novo classification by Bay Labs, Inc. with the FDA for Caption Guidance.
| DeNovo ID | DEN190040 |
| Device Name: | Caption Guidance |
| Classification | Image Acquisition And/or Optimization Guided By Artificial Intelligence |
| Applicant | Bay Labs, Inc. 290 King Street San Francisco, CA 94107 |
| Contact | Sam Surette |
| Product Code | QJU |
| CFR Regulation Number | 892.2100 [🔎] |
| 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 | 2019-08-27 |
| Decision Date | 2020-02-07 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860003586334 | DEN190040 | 000 |
| 00860003586341 | DEN190040 | 000 |