510(k) K042293 ยท JAK System, X-Ray, Tomography, Computed
BRILLIANCE CT, PRIVATE PRACTICE CV CONFIGURATION, CT SCANNER
| Applicant | Philips Medical Systems (Cleveland), Inc., Cleveland OH, US |
| Decision | Substantially Equivalent, Sep 8, 2004 |
| Received | Aug 24, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042293
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 6, 2019 | Philips Medical Systems (Cleveland) Inc Brilliance 64
Model # 728231, computed tomography x-ray system Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.