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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K203744
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 Marina Codari
Regulation Number892.2050
Classification Product Code
QIH  
Subsequent Product Code
LLZ  
Date Received12/22/2020
Decision Date 03/14/2022
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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