MDIFICATION TO MEDIPRIME

Device Classification Name

system, image processing, radiological

510(k) Number K033013
Device Name MDIFICATION TO MEDIPRIME
Applicant
ALGOTEC SYSTEMS, LTD.
p.o. box 6718
efrat, 

IL

90435

Applicant Contact eli m orbach
Correspondent
ALGOTEC SYSTEMS, LTD.
p.o. box 6718
efrat, 

IL

90435

Correspodent Contact eli m orbach
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 09/26/2003
Decision Date 11/25/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No