WBR XPRESS PET


Device Classification Name

system, tomography, computed, emission

510(k) Number K103710
Device Name WBR XPRESS PET
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  
Date Received 12/20/2010
Decision Date 01/19/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No