FDA 510(k)

Overjet 瞳孔智能成像系统

K号: K253930 · 2026-04-10

决定日期2026-04-10

产品代码QIH

咨询委员会RA

决定实质等同

器械摘要

Overjet Iris Intelligent Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Overjet, Inc.. It received FDA 510(k) clearance on 2026-04-10 under 510(k) number K253930. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Overjet Iris Intelligent Imaging System?

Overjet Iris Intelligent Imaging System is a medical device that received FDA 510(k) clearance on 2026-04-10. The listed applicant is Overjet, Inc.. The 510(k) number is K253930.

When did Overjet Iris Intelligent Imaging System receive FDA 510(k) clearance?

Overjet Iris Intelligent Imaging System received FDA 510(k) clearance on 2026-04-10, under 510(k) number K253930.

Who is the listed applicant for Overjet Iris Intelligent Imaging System?

FDA 510(k)记录中列出Overjet, 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 Overjet Iris Intelligent Imaging System?

The FDA product code for Overjet Iris Intelligent Imaging System is QIH.

列明Overjet, 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。

K261059Overjet 多图像龋齿和图表辅助设备 K251514Overjet CBCT 辅助 K241681Overjet 图像增强辅助 K241684Overjet 绘图辅助 K233738Overjet 龋齿辅助-儿科 K233590Overjet 绘图辅助

查看所有 12 个设备 →

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。