3.0T Air MP M，3.0T Air MP L
K号: K182504 · 2018-10-12
广告
器械摘要
3.0T Air MP M, 3.0T Air MP L 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 2018-10-12 under 510(k) number K182504. 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 3.0T Air MP M, 3.0T Air MP L?
3.0T Air MP M, 3.0T Air MP L is a medical device that received FDA 510(k) clearance on 2018-10-12. The listed applicant is Ge Healthcare Coils (Usa Instruments, Inc.). The 510(k) number is K182504.
When did 3.0T Air MP M, 3.0T Air MP L receive FDA 510(k) clearance?
3.0T Air MP M, 3.0T Air MP L received FDA 510(k) clearance on 2018-10-12, under 510(k) number K182504.
Who is the listed applicant for 3.0T Air MP M, 3.0T Air MP L?
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 3.0T Air MP M, 3.0T Air MP L?
The FDA product code for 3.0T Air MP M, 3.0T Air MP L 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。
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。
广告