# K111142: Echosoft (TM)

- Pathway: 510(k) (Traditional)
- Applicant: Echometrix, LLC
- Decided: Sep 21, 2012 after 518 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: 13 generations back to K894632 (1989). 106 ancestors in all.
No later device cites it as a predicate yet.
0 of 107 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093563: IU22 Ultrasound System and Transducers, Philips Ultrasound, Inc. (2010) Summary page 1.
- K092179: Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A Version 4.0R001, Toshiba America Medical Systems, In.C (2009) Summary page 1.
- K093466: HI Vision Preirus Doagnostic Ultrasound Scanner Model HI Vision Preirus, Hitachi Medical Systems America, Inc. (2010) Summary page 2.

## Indications for use
EchoSoft™ is a software calculation package that is used with diagnostic ultrasound images to provide mechanical information about tendon and tendon-like tissues of interest that may be used by a physician, along with other medical data, to assist in clinical diagnosis. The software is intended to be used by trained professionals only.

Source page: https://510kreport.com/device/K111142
Methodology: https://510kreport.com/methodology