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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 K051549
Device Name CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM
Applicant
Digirad Corp.
13950 Stowe Dr.
Poway,  CA  92064
Applicant Contact Joel Tuckey
Correspondent
Digirad Corp.
13950 Stowe Dr.
Poway,  CA  92064
Correspondent Contact Joel Tuckey
Regulation Number892.1200
Classification Product Code
KPS  
Date Received06/13/2005
Decision Date 07/13/2005
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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