# K121223: Qlab with FHN and VPQ Plug-in

- Pathway: 510(k) (Traditional)
- Applicant: Philips Ultrasound, Inc.
- Decided: May 15, 2012 after 22 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: 7 generations back to K003525 (2000). 11 ancestors in all.
98 later devices descend from it; 3 cite it directly.
0 of 110 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070792: Qlab Quantification, Philips Ultrasound, Inc. (2007) Summary page 1.
- K113758: Voluson E6/E8/E8EXPERT/E10, GE Healthcare (2012) Summary page 1.
- K021966: Q Lab Software, Advanced Technology Laboratories, Inc. (2002) Summary page 1.
- K040686: M'ath STD, Intelligence IN Medical Technologies (2004) Summary page 1.

## Most influential descendants
- K162094: RS80A Diagnostic Ultrasound System (2016), 64 descendants of its own
- K163691: HS70A Diagnostic Ultrasound System (2017), 58 descendants of its own
- K171048: RS80A Diagnostic Ultrasound System (2017), 50 descendants of its own
- K171070: WS80A Diagnostic Ultrasound System (2017), 42 descendants of its own
- K173204: RS85 Diagnostic Ultrasound System (2018), 39 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/K121223
Methodology: https://510kreport.com/methodology