QLAB Advanced Quantification Software
K-Number: K191647 · 2019-12-20
ApplicantPhilips Health Care
Decision Date2019-12-20
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 2019-12-20 under approval number K191647. 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 2019-12-20. It is manufactured by Philips Health Care. The 510(k) number is K191647.
When was QLAB Advanced Quantification Software approved by the FDA?
QLAB Advanced Quantification Software received FDA 510(k) clearance on 2019-12-20, under approval number K191647.
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.