# K210071: SIS System (Version 5.1.0)

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Information Sciences, Inc.
- Decided: Mar 31, 2021 after 79 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: 4 generations back to K050438 (2005). 5 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192304: SIS Software Version 3.6.0, Surgical Information Sciences, Inc. (2019) Summary page 4.

## Most influential descendants
- K223032: SIS System (Version 5.6.0) (2022), 3 descendants of its own
- K230977: SIS System (2023), 2 descendants of its own
- K241083: SIS System (2024), 1 descendant of its own
- K261795: Quicktome Software Suite (2026), 0 descendants of its own

## Indications for use
SIS System 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) and globus pallidus externa and interna (GPe and GPi, respectively). Typical users of SIS System are medical professionals, including but not limited to surgeons, neurologists, and radiologists.

Source page: https://510kreport.com/device/K210071
Methodology: https://510kreport.com/methodology