SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System

Q: What is the product code of K163140?

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

FDA 510(k) K163140 · Gemss Medical Systems Co., Ltd.

Substantially Equivalent

510(k) numberK163140

Submission

Device name: SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System
Applicant: Gemss Medical Systems Co., Ltd.
Seongnam-Si, KR
Received: November 9, 2016
Decision date: May 26, 2017
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: OWB – Interventional Fluoroscopic X-Ray System
Device class: Class II (moderate risk)
Regulation: 21 CFR 892.1650
Specialty: Radiology

Interventional fluoroscopy

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More from Genoray Co., Ltd.

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K133695	Titan 11KPR · Traditional	08/07/2014SE
K132289	Gemss Medical Systems Surgical Mobile Fluoroscopic X-Ray SystemJAA · Traditional	06/16/2014SE

Questions and answers

When was SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System cleared by the FDA?

SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System (K163140) received a 510(k) decision of Substantially Equivalent on May 26, 2017, 198 days after the submission was received.

What is the product code of K163140?

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