FDA 510(k)

Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T

K号: K232021 · 2023-09-01

申请人Philips Healthcare (Suzhou) Co., Ltd.

决定日期2023-09-01

产品代码MOS

咨询委员会RA

决定实质等同

器械摘要

Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T 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 2023-09-01 under 510(k) number K232021. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T?

Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T is a medical device that received FDA 510(k) clearance on 2023-09-01. The listed applicant is Philips Healthcare (Suzhou) Co., Ltd.. The 510(k) number is K232021.

When did Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T receive FDA 510(k) clearance?

Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T received FDA 510(k) clearance on 2023-09-01, under 510(k) number K232021.

Who is the listed applicant for Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T?

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 Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T?

The FDA product code for Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T is MOS.

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 Rembra K260519Smart Fit TorsoCardiac 1.5T K242329CT Collaboration Live K232491CT 5300 K233600Smart Fit Knee 3.0T K223311Philips CT 3500

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相关器械（代码：MOS）

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。

K262330dS乳腺7通道1.5TdS乳腺7通道3.0TdS乳腺16通道1.5TdS乳腺16通道3.0TdS乳腺线圈7通道1.5TdS Sentinelle乳腺16通道1.5TdS Sentinelle乳腺16通道3.0TPhilips Medical Systems Nederland B.V.K262294dS足踝16通道1.5T；dS足踝16通道3.0T；dS高分辨率手/腕16通道1.5T；dS高分辨率手/腕16CH 3.0T；dS小肢体16通道1.5T；dS小肢体16通道3.0TPhilips Medical Systems Nederland B.V.K2609470.55T 12Ch乳腺线圈Neocoil, LLC K252587HD 8Ch 腕带阵列Shenzhen RF Tech Co., Ltd.K252876GEM Flex Coil 16-L阵列，3.0T仅接收；GEM Flex Coil 16-M阵列，3.0T仅接收；GEM Flex Coil 16-S阵列，3.0T仅接收Shenzhen RF Tech Co., Ltd.K260519Smart Fit TorsoCardiac 1.5TPhilips Healthcare (Suzhou) Co., Ltd.

官方来源

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