# K140808: Q-Station

- Pathway: 510(k) (Traditional)
- Applicant: Philips Ultrasound, Inc.
- Decided: Apr 17, 2014 after 16 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K935595 (1995). 135 ancestors in all.
No later device cites it as a predicate yet.
6 of 136 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061995: Xcelera, Philips Medical Systems North America Co. (2006) Summary page 1.
- K132304: Epiq Diagnostic Ultrasound System, Philips Ultrasound, Inc. (2013) Summary page 1.

## Recalls of this device
- May 15, 2015 · Class II · Z-1807-2015: Philips Healthcare has discovered a problem in the Philips Ultrasound Q-Station version 3.0 or higher that could result in measurements from a study (Structured Report) to be appended to subsequent st
- Nov 5, 2014 · Class II · Z-0818-2015: When using the QLAB Auto 2D Quantification (a2DQ) and Auto Cardiac Motion Quantification (aCMQ) applications, the reported End-Systolic Volume (ESV) may be smaller, and the Left Ventricular Ejection F

## Indications for use
Q-Station is application software intended to manage, view, analyze, and report qualitative and quantitative image data from ultrasound exams. It is designed to host optional advanced analysis applications via QLAB integration and provides integrated tools that allow users to manually assess and score cardiac wall motion and export images and/or exams and reports. Q-Station can view DICOM images of non-ultrasound images such as CT, MR, NMV, CR, MG, XA, PET, RT, and X-Ray modalities for reference viewing. It supports connectivity to ultrasound systems, PACS and other DICOM storage repositories.

Source page: https://510kreport.com/device/K140808
Methodology: https://510kreport.com/methodology