FDA 510(k)

DR 800 配備DSA，DR 800

K 號：K212145 · 2021-08-31

決定日期2021-08-31

產品代碼JAA

諮詢委員會RA

決定相當於

器材摘要

DR 800 with DSA, DR 800 is the device name listed in this FDA 510(k) record. The listed applicant is Agfa N.V.. It received FDA 510(k) clearance on 2021-08-31 under 510(k) number K212145. 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 DSA, DR 800?

DR 800 with DSA, DR 800 is a medical device that received FDA 510(k) clearance on 2021-08-31. The listed applicant is Agfa N.V.. The 510(k) number is K212145.

When did DR 800 with DSA, DR 800 receive FDA 510(k) clearance?

DR 800 with DSA, DR 800 received FDA 510(k) clearance on 2021-08-31, under 510(k) number K212145.

Who is the listed applicant for DR 800 with DSA, DR 800?

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

What is the FDA product code for DR 800 with DSA, DR 800?

The FDA product code for DR 800 with DSA, DR 800 is JAA.

其他以 Agfa N.V. 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：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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