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FDA 510(k)

柯爾斯頓DRX-1系統搭配DRX Plus 2530偵測器

K 號：K183245 · 2019-02-08

申請人Carestream Health, Inc.
決定日期2019-02-08
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 Plus 2530 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 2019-02-08 under 510(k) number K183245. 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 Plus 2530 Detectors?

Carestream DRX-1 System with DRX Plus 2530 Detectors is a medical device that received FDA 510(k) clearance on 2019-02-08. The listed applicant is Carestream Health, Inc.. The 510(k) number is K183245.

When did Carestream DRX-1 System with DRX Plus 2530 Detectors receive FDA 510(k) clearance?

Carestream DRX-1 System with DRX Plus 2530 Detectors received FDA 510(k) clearance on 2019-02-08, under 510(k) number K183245.

Who is the listed applicant for Carestream DRX-1 System with DRX Plus 2530 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 Plus 2530 Detectors?

The FDA product code for Carestream DRX-1 System with DRX Plus 2530 Detectors is MQB.

相關臨床試驗

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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其他以 Carestream Health, Inc. 為申請人之記錄

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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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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