IMAGEN3D


Device Classification Name

system, tomography, computed, emission

510(k) Number K122241
Device Name IMAGEN3D
Applicant
CARDIOVASCULAR IMAGING TECHNOLOGIES
9755 ridge drive
lenexa, 
KS 
66219

Applicant Contact melanie hasek
Correspondent
CARDIOVASCULAR IMAGING TECHNOLOGIES
9755 ridge drive
lenexa, 
KS 
66219

Correspodent Contact melanie hasek
Regulation Number 892.1200
Classification Product Code
KPS  
Subsequent Product Code
LLZ  
Date Received 07/27/2012
Decision Date 10/24/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No