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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 K251873
Device Name Saige-Dx
Applicant
DeepHealth, Inc.
212 Elm St.
Somerville,  MA  02144
Applicant Contact B. Nathan Hunt
Correspondent
DeepHealth, Inc.
212 Elm St.
Somerville,  MA  02144
Correspondent Contact B. Nathan Hunt
Classification Product Code
QDQ  
Date Received06/18/2025
Decision Date 08/11/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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