510(k) K234109 ยท OWB Interventional Fluoroscopic X-Ray System
Ziehm Solo FD
| Applicant | Ziehm Imaging GmbH, Nuremberg, DE |
| Decision | Substantially Equivalent, Jan 26, 2024 |
| Received | Dec 27, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K234109
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 2, 2024 | Orthoscan, Inc. Ziehm Solo FD. Interventional fluoroscopic x-ray system Open, Classified |
OWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.