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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cephalometer
510(k) Number K021372
Device Name VERAVIEWEPOCS PANORAMIC X-RAY UNIT WITH CEPHALOMETRIC CAPABILITY
Applicant
J. Morita USA, Inc.
601 13th St. NW
Suite 500 N.
Washington,  DC  20005
Applicant Contact KEITH A BARRITT
Correspondent
J. Morita USA, Inc.
601 13th St. NW
Suite 500 N.
Washington,  DC  20005
Correspondent Contact KEITH A BARRITT
Regulation Number872.1830
Classification Product Code
EAG  
Date Received04/30/2002
Decision Date 06/07/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
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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