Breast BI 7 MR线圈1.5T Mammavention
K号: K180123 · 2018-02-16
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器械摘要
Breast BI 7 MR Coil 1.5T Mammavention 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 2018-02-16 under 510(k) number K180123. 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 7 MR Coil 1.5T Mammavention?
Breast BI 7 MR Coil 1.5T Mammavention is a medical device that received FDA 510(k) clearance on 2018-02-16. The listed applicant is Noras Mri Products GmbH. The 510(k) number is K180123.
When did Breast BI 7 MR Coil 1.5T Mammavention receive FDA 510(k) clearance?
Breast BI 7 MR Coil 1.5T Mammavention received FDA 510(k) clearance on 2018-02-16, under 510(k) number K180123.
Who is the listed applicant for Breast BI 7 MR Coil 1.5T Mammavention?
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 7 MR Coil 1.5T Mammavention?
The FDA product code for Breast BI 7 MR Coil 1.5T Mammavention 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。
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。
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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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