510(k) K171119 ยท IZL System, X-Ray, Mobile
GM85
| Applicant | Samsung Electronics Co., Ltd., Suwon-Si, KR |
| Decision | Substantially Equivalent, May 12, 2017 |
| Received | Apr 14, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171119
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 6, 2019 | NeuroLogica Corporation Samsung GM85 Mobile Digital X-ray Imaging System
Product Usage:
The GM85 Digital X-ray imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained do Terminated |
IZL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.