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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Multi Format, Radiological
510(k) Number K925265
Device Name IMAGEVIEW 46000
Applicant
Canberra Industries, Inc.
150 Spring Lake Dr.
Itasca,  IL  60143
Applicant Contact JOHANNES SMITS
Correspondent
Canberra Industries, Inc.
150 Spring Lake Dr.
Itasca,  IL  60143
Correspondent Contact JOHANNES SMITS
Regulation Number892.2040
Classification Product Code
LMC  
Date Received10/19/1992
Decision Date 06/09/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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