510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K160065Substantially Equivalent

GEMSS Medical System Surgical Mobile Fluoroscopic X-ray System

Gemss Medical Systems Co., Ltd., Seongnam-Si, KR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K160065 is the FDA 510(k) clearance record for GEMSS Medical System Surgical Mobile Fluoroscopic X-ray System, a class II device, cleared for Gemss Medical Systems Co., Ltd. on under FDA product code OXO (Image-Intensified Fluoroscopic X-Ray System, Mobile). FDA's definition for product code OXO reads: "Fluoroscopy of the human body". FDA records list 4 510(k) clearances for Gemss Medical Systems Co., Ltd., from to . As of , FDA records show no recalls naming K160065.

Clearance record

Decision date
Received
(128 days to decision)
Product code
OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
Regulation
21 CFR 892.1650
Device class
Class II
Review panel
Radiology
Applicant
Gemss Medical Systems Co., Ltd. 2nd Floor, 29, Dunchon-Daero 541 Beon-Gil, Jungwon-Gu, Seongnam-Si, KR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OXO

Trailing 12 months
4 clearances under product code OXO in the twelve months to October 2026, November 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code OXO, trailing twelve months
MonthClearances
November 20252
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260