# K160065: GEMSS Medical System Surgical Mobile Fluoroscopic X-ray System

- Pathway: 510(k) (Traditional)
- Applicant: Gemss Medical Systems Co., Ltd.
- Decided: May 20, 2016 after 128 days
- Product code: OXO (Image-Intensified Fluoroscopic X-Ray System, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K973598 (1997). 5 ancestors in all.
No later device cites it as a predicate yet.
1 of 6 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032761: KMC-950 C-Arm Mobile System, United Radiology Systems, Inc. (2004) Summary page 6.

## Indications for use
KMC-650 Surgical Mobile Fluoroscopic X-ray System is indicated for use in generating fluoroscopic / radioscopic images of human anatomy. This device is not intended for interventional guided procedure & mammographic applications.

Source page: https://510kreport.com/device/K160065
Methodology: https://510kreport.com/methodology