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FDA 510(k)

QPLAQUE MR

K-Number: K073156 · 2008-03-04

ApplicantMedis Medical Imaging Systems BV
Decision Date2008-03-04
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

QPLAQUE MR is the device name listed in this FDA 510(k) record. The listed applicant is Medis Medical Imaging Systems BV. It received FDA 510(k) clearance on 2008-03-04 under 510(k) number K073156. 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 QPLAQUE MR?

QPLAQUE MR is a medical device that received FDA 510(k) clearance on 2008-03-04. The listed applicant is Medis Medical Imaging Systems BV. The 510(k) number is K073156.

When did QPLAQUE MR receive FDA 510(k) clearance?

QPLAQUE MR received FDA 510(k) clearance on 2008-03-04, under 510(k) number K073156.

Who is the listed applicant for QPLAQUE MR?

The FDA 510(k) record lists Medis Medical Imaging Systems BV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QPLAQUE MR?

The FDA product code for QPLAQUE MR is LNH.

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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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