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FDA 510(k)

QLAB QUANTIFICATION SOFTWARE

K-Number: K120525 · 2012-03-09

ApplicantPhilips Healthcare Group
Decision Date2012-03-09
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

QLAB QUANTIFICATION SOFTWARE is the device name listed in this FDA 510(k) record. The listed applicant is Philips Healthcare Group. It received FDA 510(k) clearance on 2012-03-09 under 510(k) number K120525. 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 QLAB QUANTIFICATION SOFTWARE?

QLAB QUANTIFICATION SOFTWARE is a medical device that received FDA 510(k) clearance on 2012-03-09. The listed applicant is Philips Healthcare Group. The 510(k) number is K120525.

When did QLAB QUANTIFICATION SOFTWARE receive FDA 510(k) clearance?

QLAB QUANTIFICATION SOFTWARE received FDA 510(k) clearance on 2012-03-09, under 510(k) number K120525.

Who is the listed applicant for QLAB QUANTIFICATION SOFTWARE?

The FDA 510(k) record lists Philips Healthcare Group as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QLAB QUANTIFICATION SOFTWARE?

The FDA product code for QLAB QUANTIFICATION SOFTWARE is LLZ.

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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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