510(k) K182537 ยท LLZ System, Image Processing, Radiological
RADMAX Digital Imaging Software
| Applicant | DRGEM Corporation, Gwangmyeong-Si, KR |
| Decision | Substantially Equivalent, Mar 8, 2019 |
| Received | Sep 14, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182537
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.