510(k) K222662 ยท LLZ System, Image Processing, Radiological
Vitrea CT Cardiac Analysis
| Applicant | Canon Medical Informatics, Inc., Minnetonka MN, US |
| Decision | Substantially Equivalent, Oct 14, 2022 |
| Received | Sep 2, 2022 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K222662
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.