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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Tomography, Computed, Emission
510(k) Number K031825
Device Name C.CAM
Applicant
DANISH DIAGNOSTIC DEVELOPMENT A/S
DR. NEERGAARDSVEJ 5F
HORSHOLM,  DK 2970
Applicant Contact NIELS SORENSEN
Correspondent
UNDERWRITERS LABORATORIES, INC.
12 LABORATORY DR.
RESEARCH TRIANGLE,  NC  27709
Correspondent Contact KENT DONOHUE
Regulation Number892.1200
Classification Product Code
KPS  
Date Received06/13/2003
Decision Date 06/20/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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