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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 K040028
Device Name CA-1500
Applicant
R2 Technology, Inc.
1195 W. Fremont Ave.
Sunnyvale,  CA  94087
Applicant Contact Kathy O'Shaughnessy
Correspondent
Underwriters Laboratories, Inc.
1655 Scott Blvd.
Santa Clara,  CA  95050
Correspondent Contact DENISE LEUNG KLINKER
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received01/08/2004
Decision Date 01/22/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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