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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radiological Computer-Assisted Prioritization Software For Lesions
510(k) Number K203517
Device Name Saige-Q
Applicant
DeepHealth, Inc.
1000 Massachusetts Ave.
Cambridge,  MA  02138
Applicant Contact A. Gregory Sorensen
Correspondent
DeepHealth, Inc.
1000 Massachusetts Ave.
Cambridge,  MA  02138
Correspondent Contact A Gregory Sorensen
Regulation Number892.2080
Classification Product Code
QFM  
Date Received11/30/2020
Decision Date 04/16/2021
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		 No
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