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FDA 510(k)

SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System

K-Number: K163140 · 2017-05-26

ApplicantGemss Medical Systems Co., Ltd.
Decision Date2017-05-26
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System is a medical device manufactured by Gemss Medical Systems Co., Ltd.. It received FDA 510(k) clearance on 2017-05-26 under approval number K163140. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System?

SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System is a medical device that received FDA 510(k) clearance on 2017-05-26. It is manufactured by Gemss Medical Systems Co., Ltd.. The 510(k) number is K163140.

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

SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System received FDA 510(k) clearance on 2017-05-26, under approval number K163140.

What company makes SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System?

SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System is manufactured by Gemss Medical Systems Co., Ltd..

What is the FDA product code for SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System?

The FDA product code for SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System is OWB.

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Other Devices by Gemss Medical Systems Co., Ltd.

K160065GEMSS Medical System Surgical Mobile Fluoroscopic X-ray System

Related Devices (Code: OWB)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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