FDA 510(k)

飛利浦CT大孔滑動天車配置

K 號：K181797 · 2018-08-03

申請人Phillips Medical Systems (Cleveland), Inc.

決定日期2018-08-03

產品代碼JAK

諮詢委員會RA

決定相當於

器材摘要

Philips CT Big Bore Sliding Gantry Configuration is the device name listed in this FDA 510(k) record. The listed applicant is Phillips Medical Systems (Cleveland), Inc.. It received FDA 510(k) clearance on 2018-08-03 under 510(k) number K181797. 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 Big Bore Sliding Gantry Configuration?

Philips CT Big Bore Sliding Gantry Configuration is a medical device that received FDA 510(k) clearance on 2018-08-03. The listed applicant is Phillips Medical Systems (Cleveland), Inc.. The 510(k) number is K181797.

When did Philips CT Big Bore Sliding Gantry Configuration receive FDA 510(k) clearance?

Philips CT Big Bore Sliding Gantry Configuration received FDA 510(k) clearance on 2018-08-03, under 510(k) number K181797.

Who is the listed applicant for Philips CT Big Bore Sliding Gantry Configuration?

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

What is the FDA product code for Philips CT Big Bore Sliding Gantry Configuration?

The FDA product code for Philips CT Big Bore Sliding Gantry Configuration is JAK.

相關器械（代碼：JAK）

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官方來源

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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：JAK）

官方來源