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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 K163253
Device Name Arterys Cardio DL
Applicant
Arterys, Inc.
51 Federal St., Suite 305
San Francisco,  CA  94107
Applicant Contact Golnaz Moeini
Correspondent
Arterys, Inc.
51 Federal St., Suite 305
San Francisco,  CA  94107
Correspondent Contact Golnaz Moeini
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/18/2016
Decision Date 01/05/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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