510(k) K243452 ยท OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
Orthoscan VERSA Mini C-Arm
| Applicant | Ziehm-Orthoscan, Inc., Scottsdale AZ, US |
| Decision | Substantially Equivalent, Jan 14, 2025 |
| Received | Nov 7, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243452
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 23, 2026 | ZIEHM-ORTHOSCAN INC Orthoscan VERSA Accessory Cart, REF: 1000-0021 and Versa Mini C-Arm System, REF: 1000-0020 Open, Classified |
OXO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.