510(k) K191845 ยท PGY Display, Diagnostic Radiology
Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive Workflow Tools (IWT)
| Applicant | Barco N.V., Kortrijk, BE |
| Decision | Substantially Equivalent, Sep 6, 2019 |
| Received | Jul 10, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191845
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.