FDA 510(k)

네كس스 DR 디지털 X선 영상 시스템 스틀칭

K-번호: K183212 · 2018-12-07

결정일2018-12-07

제품 코드MQB

자문 위원회RA

결정Substantially Equivalent

기기 요약

Nexus DR Digital X-ray Imaging System with stitching is the device name listed in this FDA 510(k) record. The listed applicant is Varex Imaging Corporation. It received FDA 510(k) clearance on 2018-12-07 under 510(k) number K183212. 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 Nexus DR Digital X-ray Imaging System with stitching?

Nexus DR Digital X-ray Imaging System with stitching is a medical device that received FDA 510(k) clearance on 2018-12-07. The listed applicant is Varex Imaging Corporation. The 510(k) number is K183212.

When did Nexus DR Digital X-ray Imaging System with stitching receive FDA 510(k) clearance?

Nexus DR Digital X-ray Imaging System with stitching received FDA 510(k) clearance on 2018-12-07, under 510(k) number K183212.

Who is the listed applicant for Nexus DR Digital X-ray Imaging System with stitching?

The FDA 510(k) record lists Varex Imaging Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nexus DR Digital X-ray Imaging System with stitching?

The FDA product code for Nexus DR Digital X-ray Imaging System with stitching is MQB.

Varex Imaging Corporation를 신청인으로 등재한 기타 기록

K253103네ク서스 DRF 디지털 X선 영상 시스템 K193238Nexus DR 디지털 엑스선 영상 시스템 (vSharp 포함)K190146네ク서스 DR 디지털 X선 영상 시스템 K181526XRpad2 4343 HWC-M Flat Panel Detector K172951네ク서스 DR 디지털 X선 영상 시스템 (PaxScan 4343RC 및 PaxScan 4343Rv3와 함께)K171138네ク서스 DR 디지털 X선 영상 시스템

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