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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 the device name listed in this FDA 510(k) record. The listed applicant is Philips Ultrasound, Inc.. It received FDA 510(k) clearance on 2018-06-07 under 510(k) 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. The listed applicant is Philips Ultrasound, Inc.. The 510(k) number is K181264.

When did QLAB Advanced Quantification Software receive FDA 510(k) clearance?

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

Who is the listed applicant for QLAB Advanced Quantification Software?

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

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

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

Other records listing Philips Ultrasound, Inc. as applicant

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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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