# K142107: Echo True 3D Viewer

- Pathway: 510(k) (Traditional)
- Applicant: Echopixel, Inc.
- Decided: Jan 21, 2015 after 173 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K924630 (1993). 9 ancestors in all.
27 later devices descend from it; 3 cite it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123023: Surgery Rehearsal Platform, Surgical Theater, LLC (2013) Summary page 4.

## Most influential descendants
- K171356: Clarity Reveal (2017), 18 descendants of its own
- K173274: Ceevra Reveal 2.0 (2018), 17 descendants of its own
- K170167: True 3D Viewer Software (2017), 6 descendants of its own
- K222676: Ceevra Reveal 3 (2023), 5 descendants of its own
- K172418: OpenSight (2018), 5 descendants of its own

## Recalls of this device
- Apr 11, 2016 · Class II · Z-1807-2025: Imaging system data may be displayed with an incorrect orientation (sidedness) where the patient side is not correct (left, right, superior, inferior, anterior or posterior). This may lead to an inacc

## Indications for use
Intended as a medical diagnostic imaging system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from CT or MR imaging devices. It is also intended as pre-operative software for simulating / evaluating surgical treatment options. The True 3D Viewer is designed for use by health care professionals and is intended to assist the clinician who is responsible for making all final patient management decisions.

Source page: https://510kreport.com/device/K142107
Methodology: https://510kreport.com/methodology