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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
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