GEMSS Medical System Surgical Mobile Fluoroscopic X-ray System— 510(k) K160065

Substantially Equivalent

Gemss Medical Systems Co., Ltd.

FDA 510(k) clearance K160065 for GEMSS Medical System Surgical Mobile Fluoroscopic X-ray System, Substantially Equivalent on 2016-05-20. Applicant: Gemss Medical Systems Co., Ltd..

Clearance details

Applicant: Gemss Medical Systems Co., Ltd.
Product code: Code OXO
Advisory panel: Radiology
Date received: 2016-01-13
Decision date: 2016-05-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seongnam-Si, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code OXO

product code OXO

Death: 6
Injury: 163
Malfunction: 2,099
Other: 1
Total: 2,269

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.