InkSpace 成像儿童体阵列
K号: K213397 · 2021-12-17
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器械摘要
InkSpace Imaging Pediatric Body Array is the device name listed in this FDA 510(k) record. The listed applicant is Inkspace Imaging, Inc.. It received FDA 510(k) clearance on 2021-12-17 under 510(k) number K213397. 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 InkSpace Imaging Pediatric Body Array?
InkSpace Imaging Pediatric Body Array is a medical device that received FDA 510(k) clearance on 2021-12-17. The listed applicant is Inkspace Imaging, Inc.. The 510(k) number is K213397.
When did InkSpace Imaging Pediatric Body Array receive FDA 510(k) clearance?
InkSpace Imaging Pediatric Body Array received FDA 510(k) clearance on 2021-12-17, under 510(k) number K213397.
Who is the listed applicant for InkSpace Imaging Pediatric Body Array?
The FDA 510(k) record lists Inkspace Imaging, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for InkSpace Imaging Pediatric Body Array?
The FDA product code for InkSpace Imaging Pediatric Body Array 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Inkspace Imaging, 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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