510(k) K201560 ยท MYN Analyzer, Medical Image
Auto Lung Nodule Detection
| Applicant | Samsung Electronics Co., Ltd., Suwon-Si, KR |
| Decision | Substantially Equivalent, Aug 31, 2021 |
| Received | Jun 10, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201560
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.