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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 K254131
Device Name BAC
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
Regulation Number892.2050
Classification Product Code
QIH  
Date Received12/22/2025
Decision Date 05/21/2026
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		 Yes
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