FDA 510(k)

스핀엘 12HD 주사위荧光 촬영 이동형 X선 시스템

K-번호: K163140 · 2017-05-26

결정일2017-05-26

제품 코드OWB

자문 위원회[원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.]

결정Substantially Equivalent

기기 요약

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

자주 묻는 질문

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. The listed applicant is Gemss Medical Systems Co., Ltd.. The 510(k) number is K163140.

When did SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System receive FDA 510(k) clearance?

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

Who is the listed applicant for SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System?

The FDA 510(k) record lists Gemss Medical Systems Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Gemss Medical Systems Co., Ltd.를 신청인으로 등재한 기타 기록

K160065GEMSS 의료 시스템 수술용 이동형 방사선 촬영 시스템

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