CARDIOSPECT D90/CARDIO CAM


Device Classification Name

system, tomography, computed, emission

510(k) Number K021823
Device Name CARDIOSPECT D90/CARDIO CAM
Original Applicant
NUCLEAR CARDIOLOGY SYSTEMS, INC.
5660 airport blvd., suite 101
boulder, 
CO 
80301

Original Contact charlie h rose
Regulation Number 892.1200
Classification Product Code
KPS  
Date Received 06/04/2002
Decision Date 06/17/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No