FDA 510(k)

AIR前阵列，AIR后阵列

K号: K172695 · 2017-11-22

申请人Ge Healthcare Coils (Usa Instruments, Inc.)

决定日期2017-11-22

产品代码MOS

咨询委员会RA

决定实质等同

器械摘要

AIR Anterior Array, AIR Posterior Array is the device name listed in this FDA 510(k) record. The listed applicant is Ge Healthcare Coils (Usa Instruments, Inc.). It received FDA 510(k) clearance on 2017-11-22 under 510(k) number K172695. 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 AIR Anterior Array, AIR Posterior Array?

AIR Anterior Array, AIR Posterior Array is a medical device that received FDA 510(k) clearance on 2017-11-22. The listed applicant is Ge Healthcare Coils (Usa Instruments, Inc.). The 510(k) number is K172695.

When did AIR Anterior Array, AIR Posterior Array receive FDA 510(k) clearance?

AIR Anterior Array, AIR Posterior Array received FDA 510(k) clearance on 2017-11-22, under 510(k) number K172695.

Who is the listed applicant for AIR Anterior Array, AIR Posterior Array?

The FDA 510(k) record lists Ge Healthcare Coils (Usa Instruments, Inc.) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AIR Anterior Array, AIR Posterior Array?

The FDA product code for AIR Anterior Array, AIR Posterior Array is MOS.

列明Ge Healthcare Coils (Usa Instruments, 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。

K2537383.0T AIR 32CH HNA K2233783.0T 16通道AIR AA K1825043.0T Air MP M，3.0T Air MP L K18066648CH头线圈 K16320548CH头线圈

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.

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。