# K223032: SIS System (Version 5.6.0)

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Information Sciences, Inc.
- Decided: Nov 21, 2022 after 53 days
- Product code: QIH (Automated Radiological Image Processing Software)
- 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: 5 generations back to K050438 (2005). 6 ancestors in all.
3 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)
- K210071: SIS System (Version 5.1.0), Surgical Information Sciences, Inc. (2021) Summary page 4.

## Most influential descendants
- 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 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, visualization and localization. The device can be used in conjunction with other clinical methods as an aid in visualization and location of the subthalamic nuclei (STN) and globus pallidus externa and interna (GPe and GPi, respectively) in neurological procedures. The system is indicated for surgical procedures in which anatomical structure locations are identified in images, including Deep Brain Stimulation Lead Placement. Typical users of the SIS Software are medical professionals, including but not limited to surgeons, neurologists and radiologists.

Source page: https://510kreport.com/device/K223032
Methodology: https://510kreport.com/methodology