PERFSCAPE V2.0


Device Classification Name

system, image processing, radiological

510(k) Number K111161
Device Name PERFSCAPE V2.0
Applicant
OLEA MEDICAL
611 west 5th street
third floor
austin, 
TX 
78701

Applicant Contact kristi gusman
Correspondent
OLEA MEDICAL
611 west 5th street
third floor
austin, 
TX 
78701

Correspodent Contact kristi gusman
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 04/25/2011
Decision Date 11/04/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

Yes