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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 K250484
Device Name PIUR tUS inside
Applicant
Piur Imaging GmbH
Kaiserstrasse 8/1/11
Vienna,  AT 1070
Applicant Contact Milos Stojanovic
Correspondent
JW Regulatory Consulting, LLC
406 Wacouta St., Suite 417
Saint Paul,  MN  55101
Correspondent Contact Jennifer Willner
Regulation Number892.2050
Classification Product Code
QIH  
Date Received02/19/2025
Decision Date 06/30/2025
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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