510(k) K161229 ยท PGY Display, Diagnostic Radiology
Mammo Tomosynthesis (MDMG-5221)
| Applicant | Barco N.V., Kortrijk, BE |
| Decision | Substantially Equivalent, May 18, 2016 |
| Received | May 2, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K161229
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.