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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 K253628
Device Name Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012)
Applicant
Agada Medical, Ltd.
18 Haroshet St.
Ramat-Hasharon,  IL 4702519
Applicant Contact Duane Linenkugel
Correspondent
Shriner & Associates, Inc.
429 Whitepine Creek Rd.
Trout Creek,  MT  59874
Correspondent Contact Clay Anselmo
Regulation Number892.2050
Classification Product Code
QIH  
Date Received11/19/2025
Decision Date 06/29/2026
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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