FDA 510(k)

飛利浦 Incisive CT

K 號：K212441 · 2022-04-27

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

決定日期2022-04-27

產品代碼JAK

諮詢委員會RA

決定相當於

器材摘要

Philips Incisive CT 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 2022-04-27 under 510(k) number K212441. 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 Incisive CT?

Philips Incisive CT is a medical device that received FDA 510(k) clearance on 2022-04-27. The listed applicant is Philips Healthcare (Suzhou) Co., Ltd.. The 510(k) number is K212441.

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

Philips Incisive CT received FDA 510(k) clearance on 2022-04-27, under 510(k) number K212441.

Who is the listed applicant for Philips Incisive CT?

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 Incisive CT?

The FDA product code for Philips Incisive CT 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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