510(k) K092747 ยท JAK System, X-Ray, Tomography, Computed
PHILIPS COMPREHENSIVE CARDIAC ANALYSIS (CCA) - PLAQUE ASSESSMENT TOOL
| Applicant | Philips Medical Systems (Cleveland), Inc., Cleveland OH, US |
| Decision | Substantially Equivalent, Oct 9, 2009 |
| Received | Sep 8, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092747
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.