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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 detection/diagnosis software for lesions suspicious for cancer
510(k) Number K220105
Device Name Saige-Dx
Applicant
DeepHealth, Inc.
1000 Massachusetts Avenue
Cambridge,  MA  01238
Applicant Contact B. Nathan Hunt
Correspondent
DeepHealth, Inc.
1000 Massachusetts Avenue
Cambridge,  MA  01238
Correspondent Contact B. Nathan Hunt
Regulation Number892.2090
Classification Product Code
QDQ  
Date Received01/12/2022
Decision Date 05/12/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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