QLAB Advanced Quantification Software 13

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K190913 ↗

FDA Product Code

LLZ

Device Class

Class II

Regulation

21 CFR Part 892.2050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• ST80I Stress Test System

  Class II

  FDA 510(k) K121638 Active Cleared 18 Jul 2012

• Philips Lumify Diagnostic Ultrasound System Open recall

  Class II

  FDA 510(k) K152899 Active Cleared 30 Oct 2015

• QLAB Advanced Quantification Software

  Class II

  FDA 510(k) K191647 Active Cleared 20 Dec 2019

• Philips EPIQ 5 Diagnostic Ultrasound System Open recall

  Class II

  FDA 510(k) K172607 Active Cleared 4 Oct 2017

• Lumify Diagnostic Ultrasound System Open recall

  Class II

  FDA 510(k) K192226 Active Cleared 6 Sep 2019

• Lumify Ultrasound System Open recall

  Class II

  FDA 510(k) K162549 Active Cleared 3 Oct 2016

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• What is QLAB Advanced Quantification Software 13 used for?

  QLAB Advanced Quantification Software 13 is designed to view and quantify image data acquired on Philips ultrasound systems. It operates as a standalone application for offline review and quantification of ultrasound studies in radiology applications.

• How is QLAB Advanced Quantification Software 13 supplied?

  The software is supplied as a digital application and is not specified as single-use or reusable. It is compatible with standard PCs, dedicated workstations, or onboard Philips ultrasound systems.

• What regulatory status does QLAB Advanced Quantification Software 13 have?

  QLAB Advanced Quantification Software 13 has received FDA 510(k) clearance with product code LLZ. It is intended for use in radiology applications and was determined to be substantially equivalent to predicate devices.

• Is QLAB Advanced Quantification Software 13 MRI safe?

  The device is not indicated as MRI safe. It is specifically designed for viewing and quantifying ultrasound data and should only be used in accordance with its intended purpose and compatibility specifications.