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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 K252922
Device Name Neosoma Brain Mets
Applicant
Neosoma, Inc.
44 Farmers Row
Groton,  MA  01450
Applicant Contact Kenneth Kolodziej
Correspondent
Innolitics, LLC
1101 W. 34th St.
#550
Austin,  TX  78705
Correspondent Contact Meritxell Martinez
Regulation Number892.2050
Classification Product Code
QIH  
Subsequent Product Code
QKB  
Date Received09/15/2025
Decision Date 12/17/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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