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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 K030085
Device Name CARDIUS-1 AND CARDIS-2
Applicant
Digirad Corp.
9350 Trade Place
San Diego,  CA  92126 -6334
Applicant Contact COREY STEWART
Correspondent
Digirad Corp.
9350 Trade Place
San Diego,  CA  92126 -6334
Correspondent Contact COREY STEWART
Regulation Number892.1200
Classification Product Code
KPS  
Date Received01/09/2003
Decision Date 02/05/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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