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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Pre-Programmed, Single-Function
510(k) Number K253092
Device Name Argos Infinity (Rev. 1.0)
Applicant
Retia Medical Systems, Inc.
333 Westchestaer Ave.
Suite 102w
White Plains,  NY  10604
Applicant Contact Alexander Markovic
Correspondent
Retia Medical Systems, Inc.
333 Westchestaer Ave.
Suite 102w
White Plains,  NY  10604
Correspondent Contact Alexander Markovic
Regulation Number870.1435
Classification Product Code
DXG  
Date Received09/23/2025
Decision Date 02/13/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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