# K082596: Ultraextend Usws-900A

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: Sep 23, 2008 after 15 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: 10 generations back to K894632 (1989). 59 ancestors in all.
82 later devices descend from it; 2 cite it directly.
0 of 142 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071232: Image-Arena Applications and Research-Arena Applications, Tomtec Imaging Systems GmbH (2007) Summary page 1.
- K080160: Aplio Artida, Model SSH-880CV Diagnostic Ultrasound System, Toshiba America Medical Systems, In.C (2008) Summary page 1.

## Most influential descendants
- K110746: 4D LV-Analysis 3.0 (2011), 80 descendants of its own
- K132544: Tomtec-Arena 1.0, Tomtec-Arena 3D Echo, Cardio-Arena (2013), 78 descendants of its own
- K150122: Tomtec-Arena TTA2 (2015), 56 descendants of its own
- K170823: Vivid E80, Vivid E90, Vivid E95 (2017), 35 descendants of its own
- K173341: Vivid E80, Vivid E90, Vivid E95 (2017), 20 descendants of its own

## Indications for use
The USWS-900A Ultrasound Workstation, when used by a qualified physician, is intended for displaying and analyzing ultrasound images for medical diagnosis in cardiac and general examinations.

Source page: https://510kreport.com/device/K082596
Methodology: https://510kreport.com/methodology