# K200974: QLAB Advanced Quantification Software

- Pathway: 510(k) (Traditional)
- Applicant: Philips Health Care
- Decided: Jun 3, 2020 after 51 days
- Product code: QIH (Automated Radiological Image Processing Software)
- 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: 17 generations back to K935595 (1995). 144 ancestors in all.
12 later devices descend from it; 2 cite it directly.
0 of 157 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191647: QLAB Advanced Quantification Software, Philips Health Care (2019) Summary page 6.
- K150122: Tomtec-Arena TTA2, Tomtec Imaging Systems GmbH (2015) Summary page 6.

## Most influential descendants
- K201632: Tomtec-Arena (2020), 10 descendants of its own
- K213544: Tomtec-Arena (2022), 6 descendants of its own
- K230209: Sonix Health (2023), 3 descendants of its own
- K243684: BrightHeart View Classifier (2025), 1 descendant of its own
- K251417: ReVISION 2 (2026), 0 descendants of its own

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

Source page: https://510kreport.com/device/K200974
Methodology: https://510kreport.com/methodology