510(k) K982004 ยท JAK System, X-Ray, Tomography, Computed
CT CORONARY ARTERY CALCIFICATION SCORING (CACS) OPTION FOR ADVANTAGE WINDOWS
| Applicant | General Electric Co., Milwaukee WI, US |
| Decision | Substantially Equivalent, Aug 18, 1998 |
| Received | Jun 8, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982004
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.