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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, x-ray, tomographic
510(k) Number K221949
Device Name Ortho Device, ADAPTIX 3D Orthopedic Imaging System
Applicant
Pausch Medical GmbH
Graf-Zeppelin-Strabe 1
Erlangen,  DE D-91056
Applicant Contact Christian Stoian
Correspondent
Emergo Global Consulting LLC
2500 Bee Cave Road
Building 1, Suite 300
Austin,  TX  78746
Correspondent Contact Oliver Eikenberg
Regulation Number892.1740
Classification Product Code
IZF  
Subsequent Product Code
MQB  
Date Received07/05/2022
Decision Date 01/26/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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