WBR XPRESS3.CARDIAC


Device Classification Name

system, tomography, computed, emission

510(k) Number K081201
Device Name WBR XPRESS3.CARDIAC
Applicant
ULTRASPECT LTD.
6 sireni
haifa, 

IL

32972

Applicant Contact dan laor
Correspondent
ULTRASPECT LTD.
6 sireni
haifa, 

IL

32972

Correspodent Contact dan laor
Regulation Number 892.1200
Classification Product Code
KPS  
Subsequent Product Code
LLZ  
Date Received 04/28/2008
Decision Date 05/28/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No