CARDIUS-1 AND CARDIS-2


Device Classification Name

system, tomography, computed, emission

510(k) Number K030085
Device Name CARDIUS-1 AND CARDIS-2
Original Applicant
DIGIRAD CORP.
9350 trade place
san diego, 
CA 
92126 -6334

Original Contact corey stewart
Regulation Number 892.1200
Classification Product Code
KPS  
Date Received 01/09/2003
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