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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Image Acquisition And/Or Optimization Guided By Artificial Intelligence
510(k) Number K260338
Device Name ThinkSono Guidance
Applicant
ThinkSono GmbH
C/O Hpi Seed Fund Gmbh, August-Bebel-Straße 88
Potsdam,  DE 14482
Applicant Contact Fouad Al-Noor
Correspondent
ThinkSono GmbH
C/O Hpi Seed Fund Gmbh, August-Bebel-Straße 88
Potsdam,  DE 14482
Correspondent Contact Dignesh Shah
Classification Product Code
QJU  
Date Received02/02/2026
Decision Date 07/15/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Clinical Trials NCT06652568
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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