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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 K253825
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 Spence Hartwell
Classification Product Code
QDQ  
Date Received12/01/2025
Decision Date 06/15/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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