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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 K201005
Device Name FullFocus
Applicant
Paige.Ai, Inc.
11 Times Square 37th Floor
New York,  NY  10036
Applicant Contact Jillian Sue
Correspondent
Paige.Ai, Inc.
11 Times Square 37th Floor
New York,  NY  10036
Correspondent Contact Jillian Sue
Regulation Number864.3700
Classification Product Code
QKQ  
Subsequent Product Code
PSY  
Date Received04/16/2020
Decision Date 07/15/2020
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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