FDA 510(k)

レントゲン平面パネル検出器/CareView 3600RF

K番号: K202995 · 2021-02-19

申請者Careray Digital Medical System Co., Ltd.

決定日2021-02-19

製品コードMQB

諮問委員会RA （注：由于原文中未提供具体的医疗设备监管文本内容，因此无法进行翻译。请提供具体的文本内容以便进行翻译。）

決定大幅同等

医療機器の概要

X-ray Flat Panel Detectors/CareView 3600RF is the device name listed in this FDA 510(k) record. The listed applicant is Careray Digital Medical System Co., Ltd.. It received FDA 510(k) clearance on 2021-02-19 under 510(k) number K202995. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the X-ray Flat Panel Detectors/CareView 3600RF?

X-ray Flat Panel Detectors/CareView 3600RF is a medical device that received FDA 510(k) clearance on 2021-02-19. The listed applicant is Careray Digital Medical System Co., Ltd.. The 510(k) number is K202995.

When did X-ray Flat Panel Detectors/CareView 3600RF receive FDA 510(k) clearance?

X-ray Flat Panel Detectors/CareView 3600RF received FDA 510(k) clearance on 2021-02-19, under 510(k) number K202995.

Who is the listed applicant for X-ray Flat Panel Detectors/CareView 3600RF?

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

What is the FDA product code for X-ray Flat Panel Detectors/CareView 3600RF?

The FDA product code for X-ray Flat Panel Detectors/CareView 3600RF is MQB.

申請者としてCareray Digital Medical System Co., Ltd.を記載するその他の記録

K201932レントゲン平面パネル検出器（CareView 1800Cwe / CareView 1500Cwe）K193173ケアビュー 1800Le K172581ケアビュー 1800Cw X線平面パネル検出器 K163019ケアビュー 750Cw/750C レントゲン平面パネル検出器 K162178ケアビュー1500P X線フラットパネル検出器

公式ソース

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