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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interventional Fluoroscopic X-Ray System
510(k) Number K203535
Device Name Trinias
Applicant
Shimadzu Corporation Medical Systems
1, Nishinokyo-Kuwabaracho, Nakagyo-Ku
Kyoto,  JP 604-8511
Applicant Contact Shigeru Naganishi
Correspondent
Shimadzu Corporation Medical Systems
1, Nishinokyo-Kuwabaracho, Nakagyo-Ku
Kyoto,  JP 604-8511
Correspondent Contact Daniel Kamm
Regulation Number892.1650
Classification Product Code
OWB  
Date Received12/03/2020
Decision Date 04/28/2021
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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