FDA 510(k)

dS 躯干心脏 1.5T，dS MSK S 1.5T，dS MSK M 1.5T

K号: K212864 · 2021-12-01

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

决定日期2021-12-01

产品代码MOS

咨询委员会RA

决定实质等同

器械摘要

dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 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 2021-12-01 under 510(k) number K212864. 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 dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T?

dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T is a medical device that received FDA 510(k) clearance on 2021-12-01. The listed applicant is Philips Healthcare (Suzhou) Co., Ltd.. The 510(k) number is K212864.

When did dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T receive FDA 510(k) clearance?

dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T received FDA 510(k) clearance on 2021-12-01, under 510(k) number K212864.

Who is the listed applicant for dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 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 dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T?

The FDA product code for dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 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。

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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。

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