# K121076: Ultraextend FX, Ultrasound Workstation Package

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: Oct 9, 2012 after 183 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: 14 generations back to K935595 (1995). 130 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 133 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110870: Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound System, Toshiba America Medical Systems, In.C (2011) Summary page 2.
- (no number) UltraExtend (Model USWS-900A): named in the summary without a submission number

## Most influential descendants
- K250328: UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program (2025), 0 descendants of its own
- K131822: Ultraextend Usws-900A V2.1 and V3.1 (2013), 0 descendants of its own

## Indications for use
The UltraExtend FX (TUW-UCOl S) is designed to allow the user to observe images and perform analysis using the examination data acquired with specified diagnostic ultrasound systems Aplio 500, Aplio 400 and Aplio 300.

Source page: https://510kreport.com/device/K121076
Methodology: https://510kreport.com/methodology