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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 K252539
Device Name Tempus Pixel
Applicant
Arterys, Inc.
600 W Chicago Ave.
Suite #510
Chicago,  IL  60654
Applicant Contact Bethany Barrett
Correspondent
Arterys, Inc.
600 W Chicago Ave.
Suite #510
Chicago,  IL  60654
Correspondent Contact Bethany Barrett
Regulation Number892.2050
Classification Product Code
QIH  
Subsequent Product Code
LLZ  
Date Received08/12/2025
Decision Date 09/03/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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