510(k) K111638 ยท LLZ System, Image Processing, Radiological
IMPAX VOLUME VIEWING
| Applicant | Agfa Healthcare N.V., Mortsel, BE |
| Decision | Substantially Equivalent, Jun 24, 2011 |
| Received | Jun 13, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111638
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.