SMARTSPOT PRIMAX


Device Classification Name

system, image processing, radiological

510(k) Number K080890
Device Name SMARTSPOT PRIMAX
Applicant
CMT MEDICAL TECHNOLOGIES, LTD.
6 sireni
haifa, 

IL

32972

Applicant Contact dan laor
Correspondent
CMT MEDICAL TECHNOLOGIES, LTD.
6 sireni
haifa, 

IL

32972

Correspodent Contact dan laor
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 03/31/2008
Decision Date 04/29/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No