FDA 510(k)

ARIX RAD ACQUISITION CONSOLE

K-Number: K123650 · 2013-02-20

ApplicantCompania Mexicana DE Radiologia Cgr, S.A. DE C.V.

Decision Date2013-02-20

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

ARIX RAD ACQUISITION CONSOLE is the device name listed in this FDA 510(k) record. The listed applicant is Compania Mexicana DE Radiologia Cgr, S.A. DE C.V.. It received FDA 510(k) clearance on 2013-02-20 under 510(k) number K123650. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARIX RAD ACQUISITION CONSOLE?

ARIX RAD ACQUISITION CONSOLE is a medical device that received FDA 510(k) clearance on 2013-02-20. The listed applicant is Compania Mexicana DE Radiologia Cgr, S.A. DE C.V.. The 510(k) number is K123650.

When did ARIX RAD ACQUISITION CONSOLE receive FDA 510(k) clearance?

ARIX RAD ACQUISITION CONSOLE received FDA 510(k) clearance on 2013-02-20, under 510(k) number K123650.

Who is the listed applicant for ARIX RAD ACQUISITION CONSOLE?

The FDA 510(k) record lists Compania Mexicana DE Radiologia Cgr, S.A. DE C.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARIX RAD ACQUISITION CONSOLE?

The FDA product code for ARIX RAD ACQUISITION CONSOLE is LLZ.

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Official Source

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