510(k) K011624 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
EXPEDIO 500D R&F X-RAY SYSTEM
| Applicant | GE Medical Systems, Waukesha WI, US |
| Decision | Substantially Equivalent, Jun 8, 2001 |
| Received | May 25, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011624
| 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 |
| 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 |
| Aug 20, 2013 | GE Healthcare, LLC GE Healthcare, Precision 500D
Product Usage:
The Precision 500D is designed to perform radiographic and fluoroscopic x-ray examinations. Terminated |
JAA | None listed |
| Sep 19, 2008 | GE Healthcare GE Precision 500D, model 2288798, 2289299, 2290479, 2305472, 2305473, 2305495, 2336900, 2345243, 2401181, 2403790, 2403791, 2404103, 2407276, 2407576, 5179385, 2289299-2, 2290479-2, 2345260-12, 234526 Terminated |
JAA | None listed |
| Sep 18, 2008 | GE Healthcare GE Precision 500D, model 2403790-3, Radiographic and Fluoroscopic Systems. GE Healthcare, 3000 North Grandview, Waukesha, WI 53188, U.S.A. Terminated |
JAA | None listed |
| Sep 4, 2008 | GE Healthcare GE Precision 500D Classical Radiographic-Fluoroscopic
X-ray System.
Model #2289299-2, with console computer and touch screen fullly integrated. the GE Precision 500D Classical Radiographic-Fluoroscop Terminated |
JAA | None listed |
| Aug 2, 2008 | GE Healthcare Precision 500D Classical R&F System with control room PC; Image-intensified fluoroscopic x-ray system; ; Model Number: 5117866-27. Terminated |
JAA | None listed |
| Sep 22, 2006 | General Electric Med Systems LLC GE Precision 500D Radiographic and Fluoroscopic Imaging System, Stationary X-ray System consisting of an X-ray generator; angulating table with x-ray Tube, collimator and image intensifier; wall stand Terminated |
JAA | None listed |
| Feb 14, 2006 | General Electric Med Systems LLC Precision 500D Radiographic/Fluoroscopic X-ray System, model numbers 2225849, 005853. The Precision 500D system consists of an X-ray generator; angulating table with X-ray Tube, collimator and image Terminated |
JAA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.