510(k) K243989 · QIH Automated Radiological Image Processing Software
Second Opinion® 3D
| Applicant | Pearl, Inc., Beverly Hills CA, US |
| Decision | Substantially Equivalent, May 23, 2025 |
| Received | Dec 26, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243989
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.