# K081091: Precision 500D R&F X-Ray System

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Jun 11, 2008 after 56 days
- Product code: JAA (System, X-Ray, Fluoroscopic, Image-Intensified)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K862120 (1986). 4 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011624: Expedio 500D R&F X-Ray System, GE Medical Systems (2001) Summary page 1.

## Most influential descendants
- K110785: Kalare Diagnostic X-Ray Table System (2011), 2 descendants of its own
- K133553: Kalare (2014), 1 descendant of its own
- K143281: Ultimax-i (2015), 0 descendants of its own

## Recalls of this device
- Mar 29, 2019 · Class II · Z-1754-2019: There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging.
- Feb 6, 2017 · Class II · Z-2179-2017: Reported incidents of a patient step detaching from the table. A fall from a patient step detaching while in use could result in an injury to a patient or operator.
- Nov 21, 2016 · Class II · Z-0910-2017: GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX and Innova 2000 systems.
- Jun 12, 2015 · Class II · Z-1966-2015: The SFD/IDD safety mechanism may not engage properly at the lower range of SFD/IDD travel. This mechanism is installed to hold and prevent the SFD/IDD from falling due to a counterweight cable failure
- Jun 12, 2015 · Class II · Z-2120-2015: A reported incident of a monitor that fell from the suspension. A fall of a monitor could result in an injury to a patient or operator. Recall affects the single and dual LCD monitor suspensions used 
- Sep 5, 2014 · Class II · Z-0010-2015: GE Healthcare has become aware of a potential safety issue involving missing screws used for mounting the overhead Video Monitor to the tray assembly on a single monitor suspension. This issue affects
- Dec 12, 2013 · Class II · Z-0911-2014: GE Healthcare has recently become aware of a potential safety issue involving the Precision 500D, Precision MPI & Precision RXI X-ray imaging systems overhead LCD Video Monitor Suspension (Single moni
- Nov 8, 2013 · Class II · Z-0804-2014: Missing screws in the overhead Video Monitor Suspension. GE discovered that the 4 outer screws that hold the overhead Video Monitor Suspension to the carriage were missing since installation of the sy
- Aug 30, 2013 · Class II · Z-0012-2014: GE Healthcare has recently become aware of a potential safety issue involving the spotfilm device power assist handle. There is a potential for the internal bolts on the power assist handle to be loos

## Indications for use
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 examinations. The Precision 500D R&F X-ray Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic and fluoroscopic exposures of the whole body, skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position

Source page: https://510kreport.com/device/K081091
Methodology: https://510kreport.com/methodology