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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
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