FDA 510(k)

마스1717X 무선 디지털 평면 패널探测器

K-번호: K210314 · 2021-03-02

결정일2021-03-02

제품 코드MQB

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

결정대체적으로 동일

기기 요약

Mars1717X Wireless Digital Flat Panel Detector is the device name listed in this FDA 510(k) record. The listed applicant is Iray Technology Taicang , Ltd.. It received FDA 510(k) clearance on 2021-03-02 under 510(k) number K210314. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Mars1717X Wireless Digital Flat Panel Detector?

Mars1717X Wireless Digital Flat Panel Detector is a medical device that received FDA 510(k) clearance on 2021-03-02. The listed applicant is Iray Technology Taicang , Ltd.. The 510(k) number is K210314.

When did Mars1717X Wireless Digital Flat Panel Detector receive FDA 510(k) clearance?

Mars1717X Wireless Digital Flat Panel Detector received FDA 510(k) clearance on 2021-03-02, under 510(k) number K210314.

Who is the listed applicant for Mars1717X Wireless Digital Flat Panel Detector?

The FDA 510(k) record lists Iray Technology Taicang , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Mars1717X Wireless Digital Flat Panel Detector?

The FDA product code for Mars1717X Wireless Digital Flat Panel Detector is MQB.

Iray Technology Taicang , Ltd.를 신청인으로 등재한 기타 기록

K223010포터블 X선 시스템 K222886메르쿠 1717V K221714플랫폼 디텍터 K221345Wireless Digital Flat Panel Detector K220536디지털 플랫폼 패널探测器 K220668Wireless Digital Flat Panel Detector

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