510(k) K243647 ยท QIH Automated Radiological Image Processing Software
Synapse PACS (7.5)
| Applicant | FUJIFILM Healthcare Americas Corporation, Lexington MA, US |
| Decision | Substantially Equivalent, Jun 30, 2025 |
| Received | Nov 26, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243647
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.