INTUITION


Device Classification Name

system, image processing, radiological

510(k) Number K121916
Device Name INTUITION
Applicant
TERARECON, INC.
4000 e 3rd ave ste 200
foster city, 
CA 
94404

Applicant Contact robert taylor
Correspondent
TERARECON, INC.
4000 e 3rd ave ste 200
foster city, 
CA 
94404

Correspodent Contact robert taylor
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 07/02/2012
Decision Date 04/02/2013
Decision

substantially equivalent

(SESE)
Regulation Medical Specialty

Radiology

510k Review Panel

Radiology
summary

summary

Type Traditional
Reviewed by Third Party No
Combination Product

No
Recalls CDRH Recalls