510(k) K133174 ยท OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
ORTHOSCAN FD MINI C-ARM
| Applicant | Orthoscan, Inc., Scottsdale AZ, US |
| Decision | Substantially Equivalent, Mar 28, 2014 |
| Received | Oct 17, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133174
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 31, 2017 | Orthoscan, Inc. Mobile Mini C-arm system Part # 1000-0004-FD.
Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures a Terminated |
OXO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.