FDA 510(k)

CARESTREAM Vue PACS

K 號：K153103 · 2016-02-12

決定日期2016-02-12

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

CARESTREAM Vue PACS 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 2016-02-12 under 510(k) number K153103. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CARESTREAM Vue PACS?

CARESTREAM Vue PACS is a medical device that received FDA 510(k) clearance on 2016-02-12. The listed applicant is Carestream Health, Inc.. The 510(k) number is K153103.

When did CARESTREAM Vue PACS receive FDA 510(k) clearance?

CARESTREAM Vue PACS received FDA 510(k) clearance on 2016-02-12, under 510(k) number K153103.

Who is the listed applicant for CARESTREAM Vue PACS?

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 Vue PACS?

The FDA product code for CARESTREAM Vue PACS is LLZ.

其他以 Carestream Health, Inc. 為申請人之記錄

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相關器械（代碼：LLZ）

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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