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FDA 510(k)

ARiX RAD Radiographic System

K-Number: K182134 · 2018-11-26

ApplicantCompania Mexicana DE Radiologia Cgr, S.A. DE C.V.
Decision Date2018-11-26
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ARiX RAD Radiographic System is a medical device manufactured by Compania Mexicana DE Radiologia Cgr, S.A. DE C.V.. It received FDA 510(k) clearance on 2018-11-26 under approval number K182134. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARiX RAD Radiographic System?

ARiX RAD Radiographic System is a medical device that received FDA 510(k) clearance on 2018-11-26. It is manufactured by Compania Mexicana DE Radiologia Cgr, S.A. DE C.V.. The 510(k) number is K182134.

When was ARiX RAD Radiographic System approved by the FDA?

ARiX RAD Radiographic System received FDA 510(k) clearance on 2018-11-26, under approval number K182134.

What company makes ARiX RAD Radiographic System?

ARiX RAD Radiographic System is manufactured by Compania Mexicana DE Radiologia Cgr, S.A. DE C.V..

What is the FDA product code for ARiX RAD Radiographic System?

The FDA product code for ARiX RAD Radiographic System is KPR.

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Other Devices by Compania Mexicana DE Radiologia Cgr, S.A. DE C.V.

K161518PACS CORE/ENCORE K193637MRH ALFA Radiographic System, MRH II Radiographic System, MRH IIE Radiographic System

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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