# K162830: SIS Software

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Information Sciences, Inc.
- Decided: Feb 14, 2017 after 130 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: 1 generation back to K050438 (2005). 2 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050438: Stealthstation System Update, Medtronic Surgical Navigation Technologies (2005) Summary page 4.
- K081512: Stealthviz Advanced Planning Application with Stealthdti Package, Medtronic Navigation, Inc. (2008) Summary page 4.

## Most influential descendants
- K183019: SIS Software version 3.3.0 (2019), 6 descendants of its own
- K192304: SIS Software Version 3.6.0 (2019), 5 descendants of its own
- K210071: SIS System (Version 5.1.0) (2021), 4 descendants of its own
- K223032: SIS System (Version 5.6.0) (2022), 3 descendants of its own
- K230977: SIS System (2023), 2 descendants of its own

## Indications for use
SIS Software is an application intended for use in the viewing, presentation and documentation of medical imaging, including different modules for image processing, image fusion, and intraoperative functional planning where the 3D output can be used with stereotactic image guided surgery or other devices for further processing and visualization. The device can be used in conjunction with other clinical methods as an aid in visualization of the subthalamic nuclei (STN). Typical users of the SIS Software are medical professionals, including but not limited to surgeons, neurologists and radiologists.

Source page: https://510kreport.com/device/K162830
Methodology: https://510kreport.com/methodology