IMAGENMD WITH IMAGENQ


Device Classification Name

system, image processing, radiological

510(k) Number K080770
Device Name IMAGENMD WITH IMAGENQ
Applicant
CARDIOVASCULAR IMAGING TECHNOLOGIES, LLC
9755 ridge dr.
lenexa, 
KS 
66219

Applicant Contact melanie hasek
Correspondent
CARDIOVASCULAR IMAGING TECHNOLOGIES, LLC
9755 ridge dr.
lenexa, 
KS 
66219

Correspodent Contact melanie hasek
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 03/18/2008
Decision Date 04/09/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No