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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 K061173
Device Name CPIVISION DIGITAL IMAGING SYSTEM
Applicant
COMMUNICATIONS & POWER INDUSTRIES CANADA, INC.
45 RIVER DRIVE
GEORGETOWN,ONTARIO,  CA L7G 2J4
Applicant Contact NORM MORIKAWA
Correspondent
COMMUNICATIONS & POWER INDUSTRIES CANADA, INC.
45 RIVER DRIVE
GEORGETOWN,ONTARIO,  CA L7G 2J4
Correspondent Contact NORM MORIKAWA
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Code
JAA  
Date Received04/27/2006
Decision Date 06/09/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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