# K211656: 3D Echo v1.1

- Pathway: 510(k) (Traditional)
- Applicant: Jointvue, LLC
- Decided: Jun 25, 2021 after 28 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: 26 generations back to K924432 (1993). 211 ancestors in all.
No later device cites it as a predicate yet.
0 of 212 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172513: 3D Echo, Jointvue, LLC (2017) Summary page 4.

## Indications for use
JointVue’s 3D Echo v1.1 is a software application for the display and 3D visualization of ultrasound volume data derived from the Terason uSmart3200T ultrasound system. It is designed to allow the user to observe images and perform analyses of musculoskeletal structures using the ultrasound volume data acquired with the Terason ultrasound scanner. Typical users of this system are trained medical professionals including physicians, nurses, and technicians.

Source page: https://510kreport.com/device/K211656
Methodology: https://510kreport.com/methodology