# K040227: Qlab Quantification Software

- Pathway: 510(k) (Traditional)
- Applicant: Philips Ultrasound
- Decided: Feb 17, 2004 after 15 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
No predicates in its family tree.
908 later devices descend from it; 5 cite it directly.
6 of 909 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Philips M2424 Diagnostic Ultrasound System: named in the summary without a submission number
- (no number) TomTec Cardio-View: named in the summary without a submission number
- (no number) HDI 5000: named in the summary without a submission number

## Most influential descendants
- K042540: Philips IU22 Ultrasound System (2004), 882 descendants of its own
- K093563: IU22 Ultrasound System and Transducers (2010), 588 descendants of its own
- K102041: Aixplorer (2010), 527 descendants of its own
- K112255: Aixplorer (2012), 525 descendants of its own
- K121329: Aixplorer (2012), 405 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 Medical Systems ultrasound products.

Source page: https://510kreport.com/device/K040227
Methodology: https://510kreport.com/methodology