WBR XPRESS.CARDIAC, WBR XPRESS.BONE; WBR XACT.CARDIAC, WBR XACT.BONE


Device Classification Name

system, tomography, computed, emission

510(k) Number K080784
Device Name WBR XPRESS.CARDIAC, WBR XPRESS.BONE; WBR XACT.CARDIAC, WBR XACT.BONE
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 03/20/2008
Decision Date 04/02/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No