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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interventional Fluoroscopic X-Ray System
510(k) Number K234067
Device Name ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version 2.0)
Applicant
Medphoton GmbH
Karolingerstraße. 16
Salzburg,  AT 5020
Applicant Contact Thomas Fessmann
Correspondent
Medphoton GmbH
Karolingerstraße. 16
Salzburg,  AT 5020
Correspondent Contact Thomas Fessmann
Regulation Number892.1650
Classification Product Code
OWB  
Date Received12/22/2023
Decision Date 03/28/2025
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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