510(k) K012385 ยท JAK System, X-Ray, Tomography, Computed
HISPEED X/I SMART GANTRY OPTION
| Applicant | Ge Medical Systems, Inc., Milwaukee WI, US |
| Decision | Substantially Equivalent, Aug 10, 2001 |
| Received | Jul 27, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012385
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.