510(k) K241038 ยท QIH Automated Radiological Image Processing Software
Cardiac CT Function Software Application
| Applicant | Circle Cardiovascular Imaging, Calgary, CA |
| Decision | Substantially Equivalent, Jun 7, 2024 |
| Received | Apr 16, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K241038
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.