Genius AI Detection 2.0
K号: K221449 · 2022-10-06
广告
器械摘要
Genius AI Detection 2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Hologic, Inc.. It received FDA 510(k) clearance on 2022-10-06 under 510(k) number K221449. 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 Genius AI Detection 2.0?
Genius AI Detection 2.0 is a medical device that received FDA 510(k) clearance on 2022-10-06. The listed applicant is Hologic, Inc.. The 510(k) number is K221449.
When did Genius AI Detection 2.0 receive FDA 510(k) clearance?
Genius AI Detection 2.0 received FDA 510(k) clearance on 2022-10-06, under 510(k) number K221449.
Who is the listed applicant for Genius AI Detection 2.0?
FDA 510(k)记录中列出了Hologic, Inc.为申请人。这本身并不能确立该设备制造商的身份。
What is the FDA product code for Genius AI Detection 2.0?
The FDA product code for Genius AI Detection 2.0 is QDQ.
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Hologic, 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。
广告