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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K253930
Device Name Overjet Iris Intelligent Imaging System
Applicant
Overjet, Inc.
200 State St.
Suite 1220
Boston,  MA  02109
Applicant Contact Gayatri Sekaran
Correspondent
Overjet, Inc.
200 State St.
Suite 1220
Boston,  MA  02109
Correspondent Contact Gayatri Sekaran
Regulation Number892.2050
Classification Product Code
QIH  
Date Received12/09/2025
Decision Date 04/10/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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