FDA 510(k)

DR 800 配合 MUSICA 運動

K 號：K180589 · 2018-04-05

決定日期2018-04-05

產品代碼JAA

諮詢委員會RA

決定相當於

器材摘要

DR 800 with MUSICA Dynamic is the device name listed in this FDA 510(k) record. The listed applicant is Agfa Healthcare N.V.. It received FDA 510(k) clearance on 2018-04-05 under 510(k) number K180589. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DR 800 with MUSICA Dynamic?

DR 800 with MUSICA Dynamic is a medical device that received FDA 510(k) clearance on 2018-04-05. The listed applicant is Agfa Healthcare N.V.. The 510(k) number is K180589.

When did DR 800 with MUSICA Dynamic receive FDA 510(k) clearance?

DR 800 with MUSICA Dynamic received FDA 510(k) clearance on 2018-04-05, under 510(k) number K180589.

Who is the listed applicant for DR 800 with MUSICA Dynamic?

The FDA 510(k) record lists Agfa Healthcare N.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DR 800 with MUSICA Dynamic?

The FDA product code for DR 800 with MUSICA Dynamic is JAA.

其他以 Agfa Healthcare N.V. 為申請人之記錄

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K252199AGFA HealthCare Enterprise Imaging K172784DX-D影像包 K170434企業影像 XERO 觀察器 8.1 K161368DX-D影像包（DR 10s）、DX-D影像包（DR 14s）、DX-D影像包（DR 14s）K161061輸出體積檢視 4.0

相關器械（代碼：JAA）

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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