# K110785: Kalare Diagnostic X-Ray Table System

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba Medical Systems Coporation, Japan
- Decided: May 27, 2011 after 67 days
- Product code: JAA (System, X-Ray, Fluoroscopic, Image-Intensified)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K862120 (1986). 5 ancestors in all.
2 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)
- K081091: Precision 500D R&F X-Ray System, GE Healthcare (2008) Summary page 2.

## Most influential descendants
- K133553: Kalare (2014), 1 descendant of its own
- K143281: Ultimax-i (2015), 0 descendants of its own

## Recalls of this device
- Apr 3, 2013 · Class II · Z-1598-2013: Firm initiated recall because when radiographic conditions with the small focus are set and the radiography ready switch is held down, the large focus is also heated after a few seconds or more. This 

## Indications for use
1. Intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations. 2. Intended for use by a qualified/trained doctor or technologist on both adult and pediatric subjects 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/K110785
Methodology: https://510kreport.com/methodology