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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Digital Pathology Image Viewing And Management Software
510(k) Number K241273
Device Name FullFocus
Applicant
Paige.Ai, Inc.
11 Times Sq
Floor 37
New York,  NY  10036
Applicant Contact Mufaddal Jafferji
Correspondent
Paige.Ai, Inc.
11 Times Sq
Floor 37
New York,  NY  10036
Correspondent Contact Mufaddal Jafferji
Regulation Number864.3700
Classification Product Code
QKQ  
Subsequent Product Code
PSY  
Date Received05/06/2024
Decision Date 01/09/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Pathology
510k Review Panel Pathology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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