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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 K182034
Device Name Arterys MICA
Applicant
Arterys Inc.
51 Federal Street, Suite 305
San Francisco,  CA  94107
Applicant Contact Sharon Cholowsky
Correspondent
Arterys Inc.
51 Federal Street, Suite 305
San Francisco,  CA  94107
Correspondent Contact Sharon Cholowsky
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received07/30/2018
Decision Date 10/17/2018
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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