510(k) K862120 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
SCX SYSTEM
| Applicant | General Electric Co., Milwaukee WI, US |
| Decision | Substantially Equivalent, Jun 16, 1986 |
| Received | Jun 3, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K862120
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 22, 2017 | GE Healthcare, LLC Table Patient Step on RFX/SFX, Legacy, and Precision 500D systems Terminated |
IXR | None listed |
| Nov 21, 2016 | GE Healthcare, LLC Legacy Terminated |
JAA | None listed |
| Jan 21, 2014 | GE Healthcare, LLC Video Monitor Suspensions that may be on the following Fluoroscopic and Radiographic X-Ray systems: Precision 500D, Legacy, Prestilix, Monitrol, RFX, SFX, Tilt-C, Prestige VH, Prestige SI, and Presti Terminated |
JAA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.