# K132165: Qlab Quantification Software

- Pathway: 510(k) (Traditional)
- Applicant: Philips Ultrasound, Inc.
- Decided: Aug 9, 2013 after 28 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K935595 (1995). 83 ancestors in all.
91 later devices descend from it; 3 cite it directly.
0 of 175 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042540: Philips IU22 Ultrasound System, Philips Ultrasound, Inc. (2004) Summary page 1.
- K070792: Qlab Quantification, Philips Ultrasound, Inc. (2007) Summary page 1.
- K120525: Qlab Quantification Software, Philips Healthcare Group (2012) Summary page 1.
- K130159: Qlab Quantification Software Heart Model, Philips Health Care (2013) Summary page 1.

## Most influential descendants
- K171314: QLAB Advanced Quantification Software (2017), 45 descendants of its own
- K181264: QLAB Advanced Quantification Software (2018), 44 descendants of its own
- K172162: ACUSON S3000 S2000 S1000 Diagnostic Ultrasound Systems (2017), 43 descendants of its own
- K191647: QLAB Advanced Quantification Software (2019), 41 descendants of its own
- K180067: ACUSON X800 Diagnostic Ultrasound System (2018), 28 descendants of its own

## Recalls of this device
- Nov 5, 2014 · Class II · Z-0815-2015: When using the QLAB Auto 2D Quantification (a2DQ) and Auto Cardiac Motion Quantification (aCMQ) applications, the reported End-Systolic Volume (ESV) may be smaller, and the Left Ventricular Ejection F

## Indications for use
QLAB Quantification Software is a software application package. It is designed to view and quantify image data acquired on Philips Healthcare ultrasound products.

Source page: https://510kreport.com/device/K132165
Methodology: https://510kreport.com/methodology