510(k) K243688 ยท QDQ Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
Saige-Dx (3.1.0)
| Applicant | DeepHealth, Inc., Somerville MA, US |
| Decision | Substantially Equivalent, Dec 19, 2024 |
| Received | Nov 29, 2024 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K243688
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.