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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
Correspondent Contact ROBERT TAYLOR
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received07/02/2012
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
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