# K760466: Table, X-Ray, RFX Classical

- Pathway: 510(k) (Traditional)
- Applicant: General Electric Co.
- Decided: Aug 26, 1976 after 8 days
- Product code: IXR (Table, Radiographic, Tilting)
- Device class: 2
- Regulation: 21 CFR 892.1980
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- 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-0915-2017: 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.
- 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
- Mar 9, 2007 · Not classified · Z-0200-2009: GE Healthcare has recently become aware of a potential risk of monitor dropping associated with the monitor suspension of the Advantx system that may impact patient safety. It has been reported that s
- Mar 30, 2004 · Not classified · Z-0852-04: The ball joint that attaches the single monitor platform to the system boom could fail causing the monitor to fall.
- Mar 30, 2004 · Not classified · Z-0851-04: The ball joint that attaches the single monitor platform to the system boom could fail causing the monitor to fall.
- Mar 30, 2004 · Not classified · Z-0850-04: The ball joint that attaches the single monitor platform to the system boom could fail causing the monitor to fall.
- Mar 30, 2004 · Not classified · Z-0853-04: The ball joint that attaches the single monitor platform to the system boom could fail causing the monitor to fall.

Source page: https://510kreport.com/device/K760466
Methodology: https://510kreport.com/methodology