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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 K241681
Device Name Overjet Image Enhancement 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  
Subsequent Product Code
LLZ  
Date Received06/11/2024
Decision Date 09/09/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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