# K162375: Envision 3D: Image Guidance System

- Pathway: 510(k) (Traditional)
- Applicant: 7D Surgical, Inc.
- Decided: Dec 29, 2016 after 127 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K050438 (2005). 2 ancestors in all.
21 later devices descend from it; 5 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133444: Stealthstation S7 / I7 / Fusion Navigation Systems, Axiem Navigation System, Medtronic Navigation, Inc. (2014) Summary page 4.

## Most influential descendants
- K180352: 7D Surgical System (2018), 8 descendants of its own
- K181041: 7D Surgical System Cranial Application (2018), 6 descendants of its own
- K192945: 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application (2019), 5 descendants of its own
- K230661: Zeta Cranial Navigation System (2023), 3 descendants of its own
- K222291: Paradigm System (2023), 3 descendants of its own

## Indications for use
The Envision 3D™: Image Guidance System is a stereotaxic image guidance system intended for the spatial positioning and orientation of neurosurgical instruments used by surgeons. The system is also intended to be used as the primary surgical luminaire during image guided surgery. The device is indicated for posterior approach spine surgery where reference to a rigid anatomical structure can be identified.

Source page: https://510kreport.com/device/K162375
Methodology: https://510kreport.com/methodology