DIRECTPATH


Device Classification Name

system, image processing, radiological

510(k) Number K121449
Device Name DIRECTPATH
Applicant
CYBERNET SYSTEMS CO., LTD.
611 west 5th st.
austin, 
TX 
78701

Applicant Contact diane sudduth
Correspondent
CYBERNET SYSTEMS CO., LTD.
611 west 5th st.
austin, 
TX 
78701

Correspodent Contact diane sudduth
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 05/15/2012
Decision Date 07/10/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No