FDA 510(k)

P-140-Flex线圈，Na-140-Flex线圈，C-140-Flex线圈

K号: K163661 · 2018-03-21

决定日期2018-03-21

产品代码MOS

咨询委员会RA

决定实质等同

器械摘要

P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil is the device name listed in this FDA 510(k) record. The listed applicant is Rapid Biomedical GmbH. It received FDA 510(k) clearance on 2018-03-21 under 510(k) number K163661. 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 P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil?

P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil is a medical device that received FDA 510(k) clearance on 2018-03-21. The listed applicant is Rapid Biomedical GmbH. The 510(k) number is K163661.

When did P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil receive FDA 510(k) clearance?

P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil received FDA 510(k) clearance on 2018-03-21, under 510(k) number K163661.

Who is the listed applicant for P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil?

The FDA 510(k) record lists Rapid Biomedical GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil?

The FDA product code for P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil is MOS.

列明Rapid Biomedical GmbH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。

K21348031P/1H 头线圈，23Na/1H 头线圈，13C/1H 头线圈 K1915391.5T 腹腔内线圈，3.0T 腹腔内线圈，ER 线圈支架 K1819481.5T 16Ch 诊断乳腺线圈，3.0T 16Ch 诊断乳腺线圈

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.

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