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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K223125
Device Name XR90 (XR90-SYS)
Applicant
MediView XR, Inc.
10000 Cedar Ave
STE# GCIC 2-153
Cleveland,  OH  44106
Applicant Contact Adam Cargill
Correspondent
MediView XR, Inc.
10000 Cedar Ave
STE# GCIC 2-153
Cleveland,  OH  44106
Correspondent Contact Adam Cargill
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received10/03/2022
Decision Date 07/13/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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