GEMSS Medical System Surgical Mobile Fluoroscopic X-ray System

FDA 510(k) K160065 · Gemss Medical Systems Co., Ltd.

Substantially Equivalent

510(k) numberK160065

Submission

Device name
GEMSS Medical System Surgical Mobile Fluoroscopic X-ray System
Applicant
Gemss Medical Systems Co., Ltd.
Seongnam-Si, KR
Received
January 13, 2016
Decision date
May 20, 2016
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
OXO – Image-Intensified Fluoroscopic X-Ray System, Mobile
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1650
Specialty
Radiology

Fluoroscopy of the human body.

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More from Ge Oec Medical Systems, Inc.

510(k)DeviceDecision
K163140SPINEL 12HD Interventional Fluoroscopic Mobile X-ray SystemOWB · Traditional 05/26/2017SE
K133695Titan 11KPR · Traditional 08/07/2014SE
K132289Gemss Medical Systems Surgical Mobile Fluoroscopic X-Ray SystemJAA · Traditional 06/16/2014SE

Questions and answers

When was GEMSS Medical System Surgical Mobile Fluoroscopic X-ray System cleared by the FDA?

GEMSS Medical System Surgical Mobile Fluoroscopic X-ray System (K160065) received a 510(k) decision of Substantially Equivalent on May 20, 2016, 128 days after the submission was received.

What is the product code of K160065?

The FDA product code is OXO – Image-Intensified Fluoroscopic X-Ray System, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1650.