# K170167: True 3D Viewer Software

- Pathway: 510(k) (Special)
- Applicant: Echopixel, Inc.
- Decided: Mar 3, 2017 after 43 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: 8 generations back to K924630 (1993). 10 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142107: Echo True 3D Viewer, Echopixel, Inc. (2015) Summary page 4.

## Most influential descendants
- K172418: OpenSight (2018), 5 descendants of its own
- K221796: Cyware 4H and Cysart 4H (2022), 1 descendant of its own
- K213128: IntraOp VSP Software Device (2022), 1 descendant of its own
- K243069: Lumys (V1) (2025), 0 descendants of its own
- K232189: OrionXR (2023), 0 descendants of its own

## Recalls of this device
- Feb 21, 2018 · Class II · Z-1785-2025: With certain software versions, import of enhanced ultrasound formatted data/ultrasound images into 3D viewer, (for digital image processing/review/analysis/communication/media interchange acquired fr

## Indications for use
The True 3D Viewer Software is intended for processing, review, analysis, communication and media interchange of digital images acquired from CT, MRI and Ultrasound sources. It is also intended as software for pre-operative analysis of surgical options. The True 3D Viewer Software is designed for use only with performance tested hardware specified in the user documentation. The device is intended to be used by health care professionals, who are responsible for making all final patient management decisions.

Source page: https://510kreport.com/device/K170167
Methodology: https://510kreport.com/methodology