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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 K243705
Device Name Saige-Density (2.5.0)
Applicant
DeepHealth, Inc
212 Elm Street
Somerville,  MA  02144
Applicant Contact B. Nathan Hunt
Correspondent
DeepHealth, Inc
212 Elm Street
Somerville,  MA  02144
Correspondent Contact B. Nathan Hunt
Regulation Number892.2050
Classification Product Code
QIH  
Date Received11/29/2024
Decision Date 12/19/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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