510(k) K051754 ยท OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
ORTHOSCAN, ORTHOSCAN HD
| Applicant | Orthoscan, Inc., Scottsdale AZ, US |
| Decision | Substantially Equivalent, Aug 9, 2005 |
| Received | Jun 29, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051754
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 31, 2017 | Orthoscan, Inc. Mobile Mini C-arm system Part # 1000-0001.
Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures and Terminated |
OXO | None listed |
| Aug 31, 2017 | Orthoscan, Inc. Mobile Mini C-arm system Part # 1000-0004.
Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures and Terminated |
OXO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.