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FDA 510(k)

QLAB Advanced Quantification Software

K-Number: K200974 · 2020-06-03

ApplicantPhilips Health Care
Decision Date2020-06-03
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

QLAB Advanced Quantification Software is a medical device manufactured by Philips Health Care. It received FDA 510(k) clearance on 2020-06-03 under approval number K200974. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QLAB Advanced Quantification Software?

QLAB Advanced Quantification Software is a medical device that received FDA 510(k) clearance on 2020-06-03. It is manufactured by Philips Health Care. The 510(k) number is K200974.

When was QLAB Advanced Quantification Software approved by the FDA?

QLAB Advanced Quantification Software received FDA 510(k) clearance on 2020-06-03, under approval number K200974.

What company makes QLAB Advanced Quantification Software?

QLAB Advanced Quantification Software is manufactured by Philips Health Care.

What is the FDA product code for QLAB Advanced Quantification Software?

The FDA product code for QLAB Advanced Quantification Software is QIH.

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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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