Lunit INSIGHT DBT
K号: K231470 · 2023-11-06
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器械摘要
Lunit INSIGHT DBT is the device name listed in this FDA 510(k) record. The listed applicant is Lunit, Inc.. It received FDA 510(k) clearance on 2023-11-06 under 510(k) number K231470. The device is classified under product code QDQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Lunit INSIGHT DBT?
Lunit INSIGHT DBT is a medical device that received FDA 510(k) clearance on 2023-11-06. The listed applicant is Lunit, Inc.. The 510(k) number is K231470.
When did Lunit INSIGHT DBT receive FDA 510(k) clearance?
Lunit INSIGHT DBT received FDA 510(k) clearance on 2023-11-06, under 510(k) number K231470.
Who is the listed applicant for Lunit INSIGHT DBT?
The FDA 510(k) record lists Lunit, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Lunit INSIGHT DBT?
The FDA product code for Lunit INSIGHT DBT is QDQ.
相关临床试验
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列明Lunit, 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：QDQ）
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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