# K130159: Qlab Quantification Software Heart Model

- Pathway: 510(k) (Traditional)
- Applicant: Philips Health Care
- Decided: May 13, 2013 after 110 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K935595 (1995). 80 ancestors in all.
92 later devices descend from it; 1 cites it directly.
0 of 173 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040227: Qlab Quantification Software, Philips Ultrasound (2004) Summary page 1.
- K042540: Philips IU22 Ultrasound System, Philips Ultrasound, Inc. (2004) Summary page 1.
- K042293: Brilliance CT, Private Practice CV Configuration, CT Scanner, Philips Medical Systems (Cleveland), Inc. (2004) Summary page 2.
- K091286: Syngo US Workplace, Siemens Medical Solutions USA, Inc. (2009)

## Most influential descendants
- K132165: Qlab Quantification Software (2013), 91 descendants of its own
- 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

## 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/K130159
Methodology: https://510kreport.com/methodology