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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 K173517
Device Name RADspeed fit
Applicant
Shimadzu Corporation
1 Nishinokyo-Kuwabaracho Nakagyo-Ku
Kyoto,  JP 604-8511
Applicant Contact Toshio Kadowaki
Correspondent
Shimadzu Medical Systems
20101 S. Vermont Ave.
Torrance,  CA  90502
Correspondent Contact Jeffrey Seiler
Regulation Number892.1680
Classification Product Code
KPR  
Subsequent Product Code
MQB  
Date Received11/14/2017
Decision Date 03/30/2018
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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