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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, Stationary
510(k) Number K233719
Device Name FDR Visionary Suite
Applicant
Shimadzu Corporation
1, Nishinokyo Kuwabara-Cho, Nakagyo-Ku
Kyoto,  JP 604-8511
Applicant Contact Koichi Kataoka
Correspondent
Kamm & Associates
8870 Ravello Ct.
Naples,  FL  34114
Correspondent Contact Daniel Kamm
Regulation Number892.1680
Classification Product Code
KPR  
Subsequent Product Code
MQB  
Date Received11/21/2023
Decision Date 03/28/2024
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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