QUANTITATIVE VASCULAR ANGIOGRAPHY – CMS


Device Classification Name

system, x-ray, angiographic

510(k) Number K023970
Device Name QUANTITATIVE VASCULAR ANGIOGRAPHY – CMS
Original Applicant
MEDIS MEDICAL IMAGING SYSTEMS, B.V.
poortgebouw rijnsburgerweg 10
leiden, 

NL

2333 aa

Original Contact j i hollander
Regulation Number 892.1600
Classification Product Code
IZI  
Date Received 11/29/2002
Decision Date 01/24/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No