Sentinel BreastScan II System
K号: K162767 · 2017-01-09
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决定日期2017-01-09
产品代码LHQ
咨询委员会OB
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器械摘要
Sentinel BreastScan II System is the device name listed in this FDA 510(k) record. The listed applicant is First Sense Medical, LLC. It received FDA 510(k) clearance on 2017-01-09 under 510(k) number K162767. The device is classified under product code LHQ. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Sentinel BreastScan II System?
Sentinel BreastScan II System is a medical device that received FDA 510(k) clearance on 2017-01-09. The listed applicant is First Sense Medical, LLC. The 510(k) number is K162767.
When did Sentinel BreastScan II System receive FDA 510(k) clearance?
Sentinel BreastScan II System received FDA 510(k) clearance on 2017-01-09, under 510(k) number K162767.
Who is the listed applicant for Sentinel BreastScan II System?
The FDA 510(k) record lists First Sense Medical, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Sentinel BreastScan II System?
The FDA product code for Sentinel BreastScan II System is LHQ.
相关临床试验
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列明First Sense Medical, LLC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：LHQ）
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。
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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