510(k) K252634 · QIH Automated Radiological Image Processing Software
Imagine® Enterprise Suite
| Applicant | Softlink International Private Limited, Aundh, IN |
| Decision | Substantially Equivalent, Jan 16, 2026 |
| Received | Aug 20, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252634
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.