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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 K243762
Device Name Synapse 3D Base Tools (V7.0)
Applicant
Fujifilm Corporation
26-30, Nishiazabu 2-Chome
Minato-Ku,  JP 106-8620
Applicant Contact Kulkarni Chaitrali
Correspondent
Fujifilm Corporation
26-30, Nishiazabu 2-Chome
Minato-Ku,  JP 106-8620
Correspondent Contact Chaitrali Kulkarni
Regulation Number892.2050
Classification Product Code
QIH  
Subsequent Product Code
LLZ  
Date Received12/06/2024
Decision Date 05/21/2025
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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