# K110414: Qlab 8.1 Quantification Software

- Pathway: 510(k) (Traditional)
- Applicant: Philips Ultrasound, Inc.
- Decided: Jun 21, 2011 after 127 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). 66 ancestors in all.
No later device cites it as a predicate yet.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093563: IU22 Ultrasound System and Transducers, Philips Ultrasound, Inc. (2010) Summary page 4.

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

Source page: https://510kreport.com/device/K110414
Methodology: https://510kreport.com/methodology