510(k) K222353 ยท IZL System, X-Ray, Mobile
GM85
| Applicant | Samsung Electronics Co., Ltd., Suwon-Si, KR |
| Decision | Substantially Equivalent, Sep 29, 2022 |
| Received | Aug 4, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222353
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 7, 2025 | NeuroLogica Corporation GM85 Digital Mobile X-ray imaging System;
Model Number: GM85; Open, Classified |
IZL | None listed |
| Feb 9, 2024 | NeuroLogica Corporation Samsung Digital Diagnostic Mobile X-ray System, Model GM85. Open, Classified |
IZL | None listed |
| Apr 19, 2023 | NeuroLogica Corporation Samsung GM85 Digital X-ray Imaging System-A Digital Diagnostic Mobile X-ray System Open, Classified |
IZL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.