FDA 510(k)

Breast BI线圈套装0.55T；Breast BI 7 MR线圈套装1.5T；Breast BI 7 MR线圈套装3T

K号: K220144 · 2022-04-08

决定日期2022-04-08

产品代码MOS

咨询委员会RA

决定实质等同

器械摘要

Breast BI Coil Set 0.55T; Breast BI 7 MR Coil Set 1.5T; Breast BI 7 MR Coil Set 3T is the device name listed in this FDA 510(k) record. The listed applicant is Noras Mri Products GmbH. It received FDA 510(k) clearance on 2022-04-08 under 510(k) number K220144. 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 Breast BI Coil Set 0.55T; Breast BI 7 MR Coil Set 1.5T; Breast BI 7 MR Coil Set 3T?

Breast BI Coil Set 0.55T; Breast BI 7 MR Coil Set 1.5T; Breast BI 7 MR Coil Set 3T is a medical device that received FDA 510(k) clearance on 2022-04-08. The listed applicant is Noras Mri Products GmbH. The 510(k) number is K220144.

When did Breast BI Coil Set 0.55T; Breast BI 7 MR Coil Set 1.5T; Breast BI 7 MR Coil Set 3T receive FDA 510(k) clearance?

Breast BI Coil Set 0.55T; Breast BI 7 MR Coil Set 1.5T; Breast BI 7 MR Coil Set 3T received FDA 510(k) clearance on 2022-04-08, under 510(k) number K220144.

Who is the listed applicant for Breast BI Coil Set 0.55T; Breast BI 7 MR Coil Set 1.5T; Breast BI 7 MR Coil Set 3T?

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

What is the FDA product code for Breast BI Coil Set 0.55T; Breast BI 7 MR Coil Set 1.5T; Breast BI 7 MR Coil Set 3T?

The FDA product code for Breast BI Coil Set 0.55T; Breast BI 7 MR Coil Set 1.5T; Breast BI 7 MR Coil Set 3T is MOS.

列明Noras Mri Products 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。

K241069iLoop 干预线圈 0.55T K211658OR 头部固定器 LUCY 配 HeadCoilSet Siemens 1.5T，OR 头部固定器 LUCY 配 HeadCoilSet Siemens 3T，OR 头部固定器 LUCY 配 HeadCoilSet Philips 1.5T，OR 头部固定器 LUCY 配 HeadCoilSet Philips 3T K180123Breast BI 7 MR线圈1.5T Mammavention

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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