FDA 510(k)

飛利浦 CT 3500

K 號：K223311 · 2022-12-22

申請人Philips Healthcare (Suzhou) Co., Ltd.

決定日期2022-12-22

產品代碼JAK

諮詢委員會RA

決定相當於

器材摘要

Philips CT 3500 is the device name listed in this FDA 510(k) record. The listed applicant is Philips Healthcare (Suzhou) Co., Ltd.. It received FDA 510(k) clearance on 2022-12-22 under 510(k) number K223311. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Philips CT 3500?

Philips CT 3500 is a medical device that received FDA 510(k) clearance on 2022-12-22. The listed applicant is Philips Healthcare (Suzhou) Co., Ltd.. The 510(k) number is K223311.

When did Philips CT 3500 receive FDA 510(k) clearance?

Philips CT 3500 received FDA 510(k) clearance on 2022-12-22, under 510(k) number K223311.

Who is the listed applicant for Philips CT 3500?

The FDA 510(k) record lists Philips Healthcare (Suzhou) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Philips CT 3500?

The FDA product code for Philips CT 3500 is JAK.

其他以 Philips Healthcare (Suzhou) Co., Ltd. 為申請人之記錄

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相關器械（代碼：JAK）

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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