FDA 510(k) Application Details - K023110

Device Classification Name System, Tomography, Computed, Emission

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510(K) Number K023110
Device Name System, Tomography, Computed, Emission
Applicant DIGIRAD CORP.
9350 TRADE PLACE
SAN DIEGO, CA 92126-6334 US
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Contact COREY STEWART
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Regulation Number 892.1200

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Classification Product Code KPS
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Date Received 09/19/2002
Decision Date 11/22/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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