CMRTOOLS AND PLUG-INS VENTRICULAR TOOLS & THALASSAEMIA TOOLS


Device Classification Name

system, image processing, radiological

510(k) Number K073194
Device Name CMRTOOLS AND PLUG-INS VENTRICULAR TOOLS & THALASSAEMIA TOOLS
Applicant
CARDIOVASCULAR IMAGING SOLUTIONS LTD.
1600 manchester way
corinth, 
TX 
76210

Applicant Contact carl thomas
Correspondent
CARDIOVASCULAR IMAGING SOLUTIONS LTD.
1600 manchester way
corinth, 
TX 
76210

Correspodent Contact carl thomas
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 11/13/2007
Decision Date 02/14/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No