510(k) K244016 ยท LLZ System, Image Processing, Radiological
iPETcertum (v1.0)
| Applicant | Claritas Healthtech Pte, Ltd., Singapore, SG |
| Decision | Substantially Equivalent, Aug 5, 2025 |
| Received | Dec 27, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K244016
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.