510(k) K191959 ยท LLZ System, Image Processing, Radiological
QuantX Breast MRI Biopsy Guidance Plugin
| Applicant | Qlarity Imaging, Chicago IL, US |
| Decision | Substantially Equivalent, Nov 8, 2019 |
| Received | Jul 23, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191959
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.