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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Tomography, Computed
510(k) Number K253836
Device Name FCT iStream Phase 2
Applicant
Fujifilm Corporation
26-30, Nishiazabu 2-Chome
Minato-Ku,  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 Number892.1750
Classification Product Code
JAK  
Date Received12/01/2025
Decision Date 09/04/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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