FDA 510(k)

過度突出虹膜智能成像系統

K 號：K253930 · 2026-04-10

決定日期2026-04-10

產品代碼QIH

諮詢委員會RA

決定相當於

器材摘要

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.

常見問題

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) 記錄將 Overjet, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Overjet Iris Intelligent Imaging System?

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

其他以 Overjet, Inc. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K261059過度突出多影像蛀牙及圖表輔助設備 K251514過顎CBCT輔助設備 K241681過顎影像強化輔助設備 K241684過顎圖表輔助設備 K233738過度咬合蛀牙輔助－兒童版 K233590過顎圖表輔助設備

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相關器械（代碼：QIH）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K260055syngo.CT 脑量化Siemens Medical Solutions USA, Inc.K262390骨專家Visiana K261368快速平台（R6.7）Ischemaview, Inc.K261623EchoPAC 軟體僅 / EchoPAC 插件（v211）GE Medical Systems Ultrasound and Primary Care Diagnostics K261677人工智慧腎臟評估（AIRA）版本 1Aramis Global AI Consultancies, LLC K2608794DMINVIA, LLC

官方來源

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