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FDA 510(k)

QLAB Advanced Quantification Software

K-Number: K181264 · 2018-06-07

ApplicantPhilips Ultrasound, Inc.
Decision Date2018-06-07
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

QLAB Advanced Quantification Software is a medical device manufactured by Philips Ultrasound, Inc.. It received FDA 510(k) clearance on 2018-06-07 under approval number K181264. 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 Advanced Quantification Software?

QLAB Advanced Quantification Software is a medical device that received FDA 510(k) clearance on 2018-06-07. It is manufactured by Philips Ultrasound, Inc.. The 510(k) number is K181264.

When was QLAB Advanced Quantification Software approved by the FDA?

QLAB Advanced Quantification Software received FDA 510(k) clearance on 2018-06-07, under approval number K181264.

What company makes QLAB Advanced Quantification Software?

QLAB Advanced Quantification Software is manufactured by Philips Ultrasound, Inc..

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

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

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Related Devices (Code: 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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