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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 K222275
Device Name Saige-Density
Applicant
DeepHealth, Inc.
1000 Massachusetts Ave.
Cambridge,  MA  01238
Applicant Contact B. Nathan Hunt
Correspondent
DeepHealth, Inc.
1000 Massachusetts Ave.
Cambridge,  MA  01238
Correspondent Contact B. Nathan Hunt
Regulation Number892.2050
Classification Product Code
QIH  
Date Received07/29/2022
Decision Date 12/16/2022
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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