510(k) K190362 ยท QFM Radiological Computer-Assisted Prioritization Software For Lesions
HealthPNX
| Applicant | Zebra Medical Vision, Ltd., Sefayim, IL |
| Decision | Substantially Equivalent, May 6, 2019 |
| Received | Feb 15, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190362
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.