FDA 510(k)

CSX-30 平板式檢測器

K 號：K162909 · 2017-01-27

申請人Canon, Inc. – Medical Equipment Group

決定日期2017-01-27

產品代碼MQB

諮詢委員會RA

決定相當於

器材摘要

CSX-30 Flat Panel Detector is the device name listed in this FDA 510(k) record. The listed applicant is Canon, Inc. – Medical Equipment Group. It received FDA 510(k) clearance on 2017-01-27 under 510(k) number K162909. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CSX-30 Flat Panel Detector?

CSX-30 Flat Panel Detector is a medical device that received FDA 510(k) clearance on 2017-01-27. The listed applicant is Canon, Inc. – Medical Equipment Group. The 510(k) number is K162909.

When did CSX-30 Flat Panel Detector receive FDA 510(k) clearance?

CSX-30 Flat Panel Detector received FDA 510(k) clearance on 2017-01-27, under 510(k) number K162909.

Who is the listed applicant for CSX-30 Flat Panel Detector?

The FDA 510(k) record lists Canon, Inc. – Medical Equipment Group as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CSX-30 Flat Panel Detector?

The FDA product code for CSX-30 Flat Panel Detector is MQB.

其他以 Canon, Inc. – Medical Equipment Group 為申請人之記錄

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相關器械（代碼：MQB）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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