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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K152716
Device Name EV Insite System
Applicant
Psp Corporation
Nishi-Azabu 28 Moribldg. Nishi-Azabu 4-16-13
Minato-Ku Tokyo,  JP 106-0031
Applicant Contact Kenji Ishida
Correspondent
Emergo
816 Congress Ave. Suite 1400
Austin,  TX  78701
Correspondent Contact Adrienne Lenz
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/21/2015
Decision Date 03/24/2016
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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