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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, Stationary
510(k) Number K182134
Device Name ARiX RAD Radiographic System
Applicant
Compania Mexicana DE Radiologia Cgr, S.A. DE C.V.
Fraccionamiento Industrial La Noria S/N
El Marques, Queretaro,  MX 76240
Applicant Contact Tonatiuh Monroy Soberon
Correspondent
Emergo Global Consulting, LLC
2500 Bee Cave Rd.
Bldg. 1, Suite 300
Austin,  TX  78746
Correspondent Contact Stuart R. Goldman
Regulation Number892.1680
Classification Product Code
KPR  
Date Received08/06/2018
Decision Date 11/26/2018
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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