Z3D CONTRAST ACUITY


Device Classification Name

system, image processing, radiological

510(k) Number K080196
Device Name Z3D CONTRAST ACUITY
Applicant
CLARIO MEDICAL IMAGING, INC.
1924 first ave., suite 4w
seattle, 
WA 
98101

Applicant Contact chris wood
Correspondent
CLARIO MEDICAL IMAGING, INC.
1924 first ave., suite 4w
seattle, 
WA 
98101

Correspodent Contact chris wood
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 01/25/2008
Decision Date 09/05/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No