510(k) K901997 ยท IZH System, X-Ray, Mammographic
X-RAY TUBE HOUSING ASSEMBLY, VARIOUS MODELS
| Applicant | Comet Ltd. C/O Radiology Resources, Inc., Switzerland, CH |
| Decision | Substantially Equivalent, Jun 6, 1990 |
| Received | May 2, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K901997
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.