510(k) K171463 ยท LLZ System, Image Processing, Radiological
ASPIRE Bellus II
| Applicant | Fujifilm Medical Systems U.S.A, Inc., Stamford CT, US |
| Decision | Substantially Equivalent, Sep 29, 2017 |
| Received | May 18, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171463
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.