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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lung Computed Tomography System, Computer-Aided Detection
510(k) Number K254075
Device Name Synapse Lung Nodule AI
Applicant
Fujifilm Corporation
26-30, Nishiazabu 2-Chome
Minato-Ku, Tokyo,  JP 106-8620
Applicant Contact Chaitrali Kulkarni
Correspondent
FUJIFILM Healthcare Americas Corporation
81 Hartwell Ave., Suite 100
Lexington,  MA  02421
Correspondent Contact Chaitrali Kulkarni
Regulation Number892.2050
Classification Product Code
OEB  
Date Received12/18/2025
Decision Date 05/27/2026
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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