FDA 510(k) K203517, Saige-Q, by DeepHealth, Inc.
FDA 510(k) K203517, Saige-Q, by DeepHealth, Inc.
| 510(k) Number | K203517 |
| Device Classification Name | Radiological Computer-Assisted Prioritization Software For Lesions |
| Device Name | Saige-Q |
| Applicant | DeepHealth, Inc. 1000 Massachusetts Ave. Cambridge, MA 02138 |
| Regulation Number | 892.208 |
| Classification Product Code | QFM |
| Date Received | 11/30/2020 |
| Decision Date | 04/16/2021 |
| Decision | Substantially Equivalent (SESE) |
| Regulation Medical Specialty | Radiology |
| 510k Review Panel | Radiology |
| Type | Traditional |
| Reviewed by Third Party | No |
| Combination Product | No |
| Total Pages | 741 |
| Redacted Pages | 403 |
| Unredacted Pages | 338 |
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