# K133553: Kalare

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: Jun 13, 2014 after 206 days
- Product code: JAA (System, X-Ray, Fluoroscopic, Image-Intensified)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K862120 (1986). 6 ancestors in all.
1 later device descends 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)
- K110785: Kalare Diagnostic X-Ray Table System, Toshiba Medical Systems Coporation, Japan (2011) Summary page 2.

## Most influential descendants
- K143281: Ultimax-i (2015), 0 descendants of its own

## Recalls of this device
- Dec 10, 2020 · Class II · Z-1101-2021: GE Healthcare has become aware of a potential safety issue associated with the improper installation of the Precision 600FP monitor suspension. A partial detachment of the monitor suspension could res
- Sep 12, 2017 · Class II · Z-0012-2018: During an examination images were displayed on the live monitor,but the images were not displayed on the system monitor nor were they saved to the hard disk.
- Jan 14, 2016 · Class II · Z-1175-2016: When a user performed radiography using the wireless FPD, a message window appeared on the monitor stating that imaging transmission was not completed with no radiographic image. It also indicated to 

## 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 prone or supine position.

Source page: https://510kreport.com/device/K133553
Methodology: https://510kreport.com/methodology