510(k) K150097 ยท IZL System, X-Ray, Mobile
GM60A-32S & GM60A-40S
| Applicant | Samsung Electronics Co., Ltd., Suwon-Si, KR |
| Decision | Substantially Equivalent, Feb 19, 2015 |
| Received | Jan 20, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150097
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 22, 2024 | NeuroLogica Corporation GM60A. Digital Diagnostic Mobile X-Ray System. Open, Classified |
IZL | None listed |
| Nov 10, 2015 | NeuroLogica Corporation Samsung GM60A-40S
Intended for use in generating radiographic images of human anatomy. Terminated |
IZI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.