510(k) K201411 ยท QIH Automated Radiological Image Processing Software
Visage Breast Density
| Applicant | Visage Imaging GmbH, Berlin, DE |
| Decision | Substantially Equivalent, Jan 29, 2021 |
| Received | May 28, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201411
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.