QuantX乳腺MRI活检引导插件
K号: K191959 · 2019-11-08
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器械摘要
QuantX Breast MRI Biopsy Guidance Plugin is the device name listed in this FDA 510(k) record. The listed applicant is Qlarity Imaging. It received FDA 510(k) clearance on 2019-11-08 under 510(k) number K191959. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the QuantX Breast MRI Biopsy Guidance Plugin?
QuantX Breast MRI Biopsy Guidance Plugin is a medical device that received FDA 510(k) clearance on 2019-11-08. The listed applicant is Qlarity Imaging. The 510(k) number is K191959.
When did QuantX Breast MRI Biopsy Guidance Plugin receive FDA 510(k) clearance?
QuantX Breast MRI Biopsy Guidance Plugin received FDA 510(k) clearance on 2019-11-08, under 510(k) number K191959.
Who is the listed applicant for QuantX Breast MRI Biopsy Guidance Plugin?
The FDA 510(k) record lists Qlarity Imaging as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for QuantX Breast MRI Biopsy Guidance Plugin?
The FDA product code for QuantX Breast MRI Biopsy Guidance Plugin is LLZ.
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相关器械（代码：LLZ）
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
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