FDA 510(k)

ケアビュー 750Cw/750C レントゲン平面パネル検出器

K番号: K163019 · 2016-12-01

申請者Careray Digital Medical System Co., Ltd.

決定日2016-12-01

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

CareView 750Cw/750C X-ray Flat Panel Detectors 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 2016-12-01 under 510(k) number K163019. 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 CareView 750Cw/750C X-ray Flat Panel Detectors?

CareView 750Cw/750C X-ray Flat Panel Detectors is a medical device that received FDA 510(k) clearance on 2016-12-01. The listed applicant is Careray Digital Medical System Co., Ltd.. The 510(k) number is K163019.

When did CareView 750Cw/750C X-ray Flat Panel Detectors receive FDA 510(k) clearance?

CareView 750Cw/750C X-ray Flat Panel Detectors received FDA 510(k) clearance on 2016-12-01, under 510(k) number K163019.

Who is the listed applicant for CareView 750Cw/750C X-ray Flat Panel Detectors?

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 CareView 750Cw/750C X-ray Flat Panel Detectors?

The FDA product code for CareView 750Cw/750C X-ray Flat Panel Detectors 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

K202995レントゲン平面パネル検出器/CareView 3600RF 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 K162178ケアビュー1500P X線フラットパネル検出器

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