510(k) K943805 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
PRESTIGE REMOTE R & F SYSTEM MODELS H, VH & VHD
| Applicant | General Electric Co., Milwaukee WI, US |
| Decision | Substantially Equivalent, Sep 23, 1994 |
| Received | Aug 4, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K943805
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 10, 2019 | GE Healthcare, LLC Prestige II, Prestige SI, Prestige VH
Prestige system is a new multi-purpose conventional and digital R/F remote controlled system. Terminated |
JAA | None listed |
| Nov 21, 2016 | GE Healthcare, LLC Prestige II Terminated |
JAA | None listed |
| Nov 21, 2016 | GE Healthcare, LLC Prestige SI Terminated |
JAA | None listed |
| Nov 21, 2016 | GE Healthcare, LLC Prestige VH 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.