# K053043: Encompass Software Package

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: Nov 18, 2005 after 21 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: 8 generations back to K894632 (1989). 54 ancestors in all.
No later device cites it as a predicate yet.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040896: Modification to Encompass, Heartlab, Inc. (2004) Summary page 1.
- K041499: Ssa-770A, Aplio Version 5.5, Toshibamedical Systems Corporation (2004) Summary page 1.
- K031663: GE Vivid 7, Model FC0003XX, General Electric Co. (2003) Summary page 1.

## Indications for use
Using the software listed to post-process images, various analysis and reconstruction can be initiated by the user to obtain clinically relevant information pertaining to cardiac and radiology. Additionally this information can be used in the detection of cardiovascular disease and radiology diagnosis and risk management. Support functions are: * URSE-001A: Stress Echo analysis of the ultrasound diagnostic images. * URFR-001A: Three-dimensional image reconstruction from the ultrasound diagnostic images for abdominal, small organs and peripheral vascular. * URTQ-001A: Following analysis from the TDI (Tissue Doppler Image) from the ultrasound diagnostic images. - Gray scale (display of only black-and-white images) - Velocity display (display of the velocity after angle correction and smoothing) - Display of the velocity gradient based on the velocity image - Display of the degree of myocardial strain based on the velocity image - Display of the displacement based on the velocity image - Display of the dyssynchrony imaging based on the above imaging methods

Source page: https://510kreport.com/device/K053043
Methodology: https://510kreport.com/methodology