# K220946: SURGIVISIO Device

- Pathway: 510(k) (Special)
- Applicant: Ecential Robotics
- Decided: Apr 15, 2022 after 14 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K973598 (1997). 7 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202547: Surgivisio system, Surgivisio (2021) Summary page 5.
- K220627: SURGIVISIO Device, Ecential Robotics (2022) Summary page 5.

## Most influential descendants
- K231886: SURGIVISIO Device (2023), 6 descendants of its own
- K242890: SPINEART Navigation Instrument System (2025), 3 descendants of its own
- K242933: SPINEART Navigation Instrument System (2025), 2 descendants of its own
- K233228: Spine Navigation and Robotic-Assistance Device (2024), 2 descendants of its own
- K261113: Op.n™ Spine Navigation and Robotic Guidance (2026), 1 descendant of its own

## Indications for use
The SURGIVISIO device is intended to be used during surgical procedures in which the physician would benefit from the visualization of 2D medical imaging and/or intraoperatively generated 3D medical imaging of anatomical structures or objects with high x-ray attenuation such as bony anatomy or metallic objects. Such procedures include procedures during which the spine, pelvis or articulation structures are visualized.

Source page: https://510kreport.com/device/K220946
Methodology: https://510kreport.com/methodology