510(k) K140445 ยท LLZ System, Image Processing, Radiological
DEXIS SOFTWARE: DEXIS IMAGING SUITE, DEXIS MAC
| Applicant | Imaging Sciences International, LLC, Hatfield PA, US |
| Decision | Substantially Equivalent, Apr 23, 2014 |
| Received | Feb 21, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K140445
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.