FDA 510(k)

柯爾斯頓DRX-1系統搭配DRX核心偵測器

K 號：K183474 · 2019-01-16

決定日期2019-01-16

產品代碼MQB

諮詢委員會RA

決定相當於

器材摘要

Carestream DRX-1 System with DRX Core Detectors is the device name listed in this FDA 510(k) record. The listed applicant is Carestream Health, Inc.. It received FDA 510(k) clearance on 2019-01-16 under 510(k) number K183474. 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 Carestream DRX-1 System with DRX Core Detectors?

Carestream DRX-1 System with DRX Core Detectors is a medical device that received FDA 510(k) clearance on 2019-01-16. The listed applicant is Carestream Health, Inc.. The 510(k) number is K183474.

When did Carestream DRX-1 System with DRX Core Detectors receive FDA 510(k) clearance?

Carestream DRX-1 System with DRX Core Detectors received FDA 510(k) clearance on 2019-01-16, under 510(k) number K183474.

Who is the listed applicant for Carestream DRX-1 System with DRX Core Detectors?

The FDA 510(k) record lists Carestream Health, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Carestream DRX-1 System with DRX Core Detectors?

The FDA product code for Carestream DRX-1 System with DRX Core Detectors is MQB.

其他以 Carestream Health, Inc. 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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