FDA 510(k)

MDIXON SOFTWARE OPTION FOR INTERA 1.5T, ACHIEVA 1.5T & ACHIEVA 3.0T MR SYSTEMS

K-Number: K102344 · 2010-11-09

ApplicantPhilips Medical Systems Nederland B.V.

Decision Date2010-11-09

Product CodeLNH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

MDIXON SOFTWARE OPTION FOR INTERA 1.5T, ACHIEVA 1.5T & ACHIEVA 3.0T MR SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2010-11-09 under 510(k) number K102344. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MDIXON SOFTWARE OPTION FOR INTERA 1.5T, ACHIEVA 1.5T & ACHIEVA 3.0T MR SYSTEMS?

MDIXON SOFTWARE OPTION FOR INTERA 1.5T, ACHIEVA 1.5T & ACHIEVA 3.0T MR SYSTEMS is a medical device that received FDA 510(k) clearance on 2010-11-09. The listed applicant is Philips Medical Systems Nederland B.V.. The 510(k) number is K102344.

When did MDIXON SOFTWARE OPTION FOR INTERA 1.5T, ACHIEVA 1.5T & ACHIEVA 3.0T MR SYSTEMS receive FDA 510(k) clearance?

MDIXON SOFTWARE OPTION FOR INTERA 1.5T, ACHIEVA 1.5T & ACHIEVA 3.0T MR SYSTEMS received FDA 510(k) clearance on 2010-11-09, under 510(k) number K102344.

Who is the listed applicant for MDIXON SOFTWARE OPTION FOR INTERA 1.5T, ACHIEVA 1.5T & ACHIEVA 3.0T MR SYSTEMS?

The FDA 510(k) record lists Philips Medical Systems Nederland B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MDIXON SOFTWARE OPTION FOR INTERA 1.5T, ACHIEVA 1.5T & ACHIEVA 3.0T MR SYSTEMS?

The FDA product code for MDIXON SOFTWARE OPTION FOR INTERA 1.5T, ACHIEVA 1.5T & ACHIEVA 3.0T MR SYSTEMS is LNH.

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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.