510(k) K243866 ยท SDJ Adjunctive Cardiac Amyloidosis Status Indicator
InVision Precision Cardiac Amyloid
| Applicant | InVision Medical Technology Corporation, Los Angeles CA, US |
| Decision | Substantially Equivalent, May 21, 2025 |
| Received | Dec 17, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243866
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.