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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 K191585
Device Name iNtuition-Structural Heart Module
Applicant
TeraRecon Inc.
4000 East, 3rd Ave, Suite 200
Foster City,  CA  94402
Applicant Contact Megha Jain
Correspondent
TeraRecon Inc.
4000 East, 3rd Ave, Suite 200
Foster City,  CA  94402
Correspondent Contact Megha Jain
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received06/14/2019
Decision Date 07/12/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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