XENOVIEW 3.0T 胸部线圈
K号: K231647 · 2023-06-29
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器械摘要
XENOVIEW 3.0T Chest Coil is the device name listed in this FDA 510(k) record. The listed applicant is Polarean, Inc.. It received FDA 510(k) clearance on 2023-06-29 under 510(k) number K231647. 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 XENOVIEW 3.0T Chest Coil?
XENOVIEW 3.0T Chest Coil is a medical device that received FDA 510(k) clearance on 2023-06-29. The listed applicant is Polarean, Inc.. The 510(k) number is K231647.
When did XENOVIEW 3.0T Chest Coil receive FDA 510(k) clearance?
XENOVIEW 3.0T Chest Coil received FDA 510(k) clearance on 2023-06-29, under 510(k) number K231647.
Who is the listed applicant for XENOVIEW 3.0T Chest Coil?
The FDA 510(k) record lists Polarean, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for XENOVIEW 3.0T Chest Coil?
The FDA product code for XENOVIEW 3.0T Chest Coil is MOS.
相关临床试验
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。
列明Polarean, Inc.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。
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, LLCK252587HD 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
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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