FDA 510(k)

ケアビュー1500P X線フラットパネル検出器

K番号: K162178 · 2016-09-01

申請者Careray Digital Medical System Co., Ltd.

決定日2016-09-01

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 1500P 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 2016-09-01 under 510(k) number K162178. 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 1500P X-ray Flat Panel Detectors?

CareView 1500P X-ray Flat Panel Detectors is a medical device that received FDA 510(k) clearance on 2016-09-01. The listed applicant is Careray Digital Medical System Co., Ltd.. The 510(k) number is K162178.

When did CareView 1500P X-ray Flat Panel Detectors receive FDA 510(k) clearance?

CareView 1500P X-ray Flat Panel Detectors received FDA 510(k) clearance on 2016-09-01, under 510(k) number K162178.

Who is the listed applicant for CareView 1500P 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 1500P X-ray Flat Panel Detectors?

The FDA product code for CareView 1500P 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 K163019ケアビュー 750Cw/750C レントゲン平面パネル検出器

公式ソース

FDAデータベースで見る →

データはFDA Open APIから取得しています。最新かつ権威ある情報については、常に公式レコードを参照してください。