# K973039: Legacy/Legacy-D Table

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems
- Decided: Oct 16, 1997 after 63 days
- Product code: IXR (Table, Radiographic, Tilting)
- Device class: 2
- Regulation: 21 CFR 892.1980
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K011624: Expedio 500D R&F X-Ray System (2001), 4 descendants of its own
- 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
- 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.
- 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
- 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
- Jan 2, 2008 · Not classified · Z-1611-2008: 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

## Indications for use
This table is intended for use in a diagnostic x-ray system to support patients during general purpose radiological procedures in the horizontal, vertical and trendelenburg positions.

Source page: https://510kreport.com/device/K973039
Methodology: https://510kreport.com/methodology