SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System— 510(k) K163140

Name: FDA 510(k) clearance K163140
Creator: U.S. Food and Drug Administration
Published: 2017-05-26

Substantially Equivalent

Gemss Medical Systems Co., Ltd.

FDA 510(k) clearance K163140 for SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System, Substantially Equivalent on 2017-05-26. Applicant: Gemss Medical Systems Co., Ltd.. Device class: 2.

Clearance details

Applicant: Gemss Medical Systems Co., Ltd.
Product code: Code OWB
Device class: Class 2
Regulation: 21 CFR 892.1650
Advisory panel: Radiology
Date received: 2016-11-09
Decision date: 2017-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seongnam-Si, KR

Download summary PDF View on FDA.gov ↗

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More clearances from Gemss Medical Systems Co., Ltd.

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K160065 — GEMSS Medical System Surgical Mobile Fluoroscopic X-ray System2016-05-20
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Adverse events under product code OWB

product code OWB

Death: 49
Injury: 340
Malfunction: 36,973
Total: 37,362

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.