510(k) K252068 ยท OWB Interventional Fluoroscopic X-Ray System
MC2 Portable X-ray System
| Applicant | Oxos Medical, Atlanta GA, US |
| Decision | Substantially Equivalent, Dec 22, 2025 |
| Received | Jul 1, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252068
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 3, 2026 | Oxos Medical Inc Brand Name: OXOS Medical, Inc
Product Name: MC2 Portable X-Ray System
Model/Catalog Number: MC2, MC2.1
Software Version: 5.7.0
Product Description: The MC2 Portable X-Ray System ( MC2 System or MC2 Open, Classified |
OWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.