510(k) K081091 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
PRECISION 500D R&F X-RAY SYSTEM
| Applicant | GE Healthcare, Waukesha WI, US |
| Decision | Substantially Equivalent, Jun 11, 2008 |
| Received | Apr 16, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081091
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 10, 2019 | GE Healthcare, LLC Precision 500D
The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric Terminated |
JAA | None listed |
| 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 Precision 500D Terminated |
JAA | None listed |
| Jul 20, 2015 | GE Healthcare GE Healthcare Precision 500D Classical R & F system. Terminated |
JAA | None listed |
| Jul 2, 2015 | GE Healthcare GE Healthcare Precision 500D and Advantx Legacy/Legacy-D Radiographic and Fluoroscopic Systems.
A universal diagnostic imaging system for radiographic and fluoroscopic examinations. Applications can Terminated |
JAA | None listed |
| Oct 2, 2014 | GE Healthcare, LLC GE Healthcare Precision 500D, Classical R&F System.
Product Usage:
The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopi Terminated |
JAA | None listed |
| Feb 3, 2014 | GE Healthcare, LLC GE Healthcare Precision 500D, Precision MPI & Precision RXI X-ray imaging systems.
The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic Terminated |
OWB | 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 |
| Oct 17, 2013 | GE Healthcare, LLC GE Healthcare, Precision 500D, Legacy, RFX, and SFX X.
This table is intended for use in a diagnostic X-ray system to support patients during general purpose radiological procedures in the horizonta Terminated |
JAA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.