# K103761: Visualize: Vascular

- Pathway: 510(k) (Traditional)
- Applicant: The Medipattern Corporation
- Decided: Feb 11, 2011 after 50 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: 5 generations back to K935595 (1995). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021966: Q Lab Software, Advanced Technology Laboratories, Inc. (2002) Summary page 1.
- K040227: Qlab Quantification Software, Philips Ultrasound (2004) Summary page 1.
- K022824: Echo-View 5.X, Easy-View 2.X, Omni View 2.X, Cardio-View 1.X, LV Analysis 1.X & Surgical View 1.X, Tomtec Imaging Systems GmbH (2002) Summary page 1.
- K040546: Image-Arena and Research-Arena Applications, Tomtec Imaging Systems GmbH (2004) Summary page 1.

## Indications for use
Visualize: Vascular is a software application package. It is designed to view and quantify image data acquired on commercially available ultrasound products. Regions of interest can be segmented, measured and annotated. The results can be displayed in 2D or 3D. The system automatically generates reports of user inputs.

Source page: https://510kreport.com/device/K103761
Methodology: https://510kreport.com/methodology