# K011624: Expedio 500D R&F X-Ray System

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems
- Decided: Jun 8, 2001 after 14 days
- Product code: JAA (System, X-Ray, Fluoroscopic, Image-Intensified)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K862120 (1986). 3 ancestors in all.
4 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)
- K862120: SCX System, General Electric Co. (1986) Summary page 2.
- K963037: Patriot, Infimed, Inc. (1996) Summary page 1.
- K973039: Legacy/Legacy-D Table, GE Medical Systems (1997). Our OCR of the scanned summary read K873039, FDA’s number for Model 820 Top=Trak (Sierra Laboratories, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Legacy/Legacy D Table”. Summary page 2.

## Most influential descendants
- K081091: Precision 500D R&F X-Ray System (2008), 3 descendants of its own
- 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 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
- May 2, 2013 · Class II · Z-1989-2013: GE Healthcare has recently become aware of a potential safety issue involving the overhead Video Monitor Suspension involving Precision 500D Systems. There is a potential for the locking nut to loosen
- Jan 2, 2008 · Not classified · Z-1610-2008: GE Healthcare was notified that 2 recently installed Precision 500D systems were not in compliance with portions of the Performance Standard for Diagnostic X-ray Equipment. X-ray production was possib
- Oct 4, 2007 · Not classified · Z-0369-2008: It was reported that when the GE Precision 500D foot pedal is repeatedly activated, a defect in the fluoro-timer will cause the dose measurement to report a higher value than was actually received by 
- Aug 13, 2007 · Not classified · Z-1477-2008: Necessary certification labels are missing from the x-ray contol.
- Aug 1, 2007 · Not classified · Z-0274-2008: Inaccurate cassette size display reading/ Inaccurate mAs reading: 1. When the device is in PBL mode and a larger film cassette is inserted into the table Bucky (replacing a smaller cassette) after a p
- May 15, 2006 · Not classified · Z-1304-06: Systems are non-compliant with Federal Performance Standard Title 21, Code of Federal Regulation (CFR), 1020.32(a)(1) in that the systems allow the production of x-rays when the primary protective bar
- Dec 30, 2004 · Not classified · Z-0220-05: Units have a defect in accordance with 21 CFR 1003.2 because an incorrect exposure can occur.

## Indications for use
The Expedio 500D is designed to perform radiographic and fluoroscopic x-ray examinations.

Source page: https://510kreport.com/device/K011624
Methodology: https://510kreport.com/methodology