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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 K982855
Device Name DIGIRAD 2020TC SPECT IMAGING SYSTEM
Applicant
Digirad Corp.
7408 Trade St.
San Diego,  CA  92121 -2410
Applicant Contact R. SCOTT HUENNEKENS
Correspondent
Digirad Corp.
7408 Trade St.
San Diego,  CA  92121 -2410
Correspondent Contact R. SCOTT HUENNEKENS
Regulation Number892.1200
Classification Product Code
KPS  
Date Received08/06/1998
Decision Date 11/04/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
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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