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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 K241684
Device Name Overjet Charting Assist
Applicant
Overjet, Inc
50 Milk Street, 16th Floor
Boston,  MA  02109
Applicant Contact Deepthi Paknikar
Correspondent
Overjet, Inc
50 Milk Street, 16th Floor
Boston,  MA  02109
Correspondent Contact Deepthi Paknikar
Regulation Number892.2050
Classification Product Code
QIH  
Date Received06/11/2024
Decision Date 08/27/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 Yes
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