FDA 510(k)

飛利浦多層切片CT系統搭配低劑量CT肺臟癌

K 號：K153444 · 2016-04-08

申請人Philips Medical Systems (Cleveland), Inc.

決定日期2016-04-08

產品代碼JAK

諮詢委員會RA

決定相當於

器材摘要

Philips Multislice CT System with Low Dose CT Lung Cancer is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems (Cleveland), Inc.. It received FDA 510(k) clearance on 2016-04-08 under 510(k) number K153444. 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 Multislice CT System with Low Dose CT Lung Cancer?

Philips Multislice CT System with Low Dose CT Lung Cancer is a medical device that received FDA 510(k) clearance on 2016-04-08. The listed applicant is Philips Medical Systems (Cleveland), Inc.. The 510(k) number is K153444.

When did Philips Multislice CT System with Low Dose CT Lung Cancer receive FDA 510(k) clearance?

Philips Multislice CT System with Low Dose CT Lung Cancer received FDA 510(k) clearance on 2016-04-08, under 510(k) number K153444.

Who is the listed applicant for Philips Multislice CT System with Low Dose CT Lung Cancer?

The FDA 510(k) record lists Philips Medical Systems (Cleveland), Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Philips Multislice CT System with Low Dose CT Lung Cancer?

The FDA product code for Philips Multislice CT System with Low Dose CT Lung Cancer is JAK.

其他以 Philips Medical Systems (Cleveland), Inc. 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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官方來源

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