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FDA 510(k)

CT 5300

K号: K232491 · 2024-05-03

申请人Philips Healthcare (Suzhou) Co., Ltd.
决定日期2024-05-03
产品代码JAK
咨询委员会RA
决定实质等同

器械摘要

CT 5300 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 2024-05-03 under 510(k) number K232491. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CT 5300?

CT 5300 is a medical device that received FDA 510(k) clearance on 2024-05-03. The listed applicant is Philips Healthcare (Suzhou) Co., Ltd.. The 510(k) number is K232491.

When did CT 5300 receive FDA 510(k) clearance?

CT 5300 received FDA 510(k) clearance on 2024-05-03, under 510(k) number K232491.

Who is the listed applicant for CT 5300?

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 CT 5300?

The FDA product code for CT 5300 is JAK.

列明Philips Healthcare (Suzhou) Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K252992CT Rembra RT; CT Areta RT; CT RembraK260519Smart Fit TorsoCardiac 1.5TK242329CT Collaboration LiveK233600Smart Fit Knee 3.0TK232021Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5TK223311Philips CT 3500

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相关器械（代码：JAK）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K261125BodyTom 64（NL4100）；OmniTom Elite（NL5000）Samsung HME America, Inc., dba NeuroLogica Corp.K261229SCENARIA 视觉阶段 6.0Fujifilm CorporationK253836FCT iStream 阶段 2Fujifilm CorporationK253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung CompanyK253770CardIQ 套件GE Medical Systems SCSK253560Enhanced Boundary for PCCTGe Medical Systems, LLC

官方来源

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