510(k) · Cleared
ClearedSIS System (Version 5.6.0)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgical Information Sciences, Inc. · QIH Automated Radiological Image Processing Software
Cleared on Nov 21, 2022 as substantially equivalent to K210071 (Surgical Information Sciences, Inc., 2021) after a 53-day review. Its family tree reaches back 5 generations to 2005. 3 later devices descend from it.
- Decided
- Nov 21, 2022
- Review
- 53 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K050438 (2005). 6 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK050438 Stealthstation System UpdateMedtronic Surgical Navigation Technologies · 2005 · Recalled
- 4 generations backK162830 SIS SoftwareSurgical Information Sciences, Inc. · 2017
- 3 generations backK183019 SIS Software version 3.3.0Surgical Information Sciences, Inc. · 2019
- 2 generations backK192304 SIS Software Version 3.6.0Surgical Information Sciences, Inc. · 2019
- 1 generation backK210071 SIS System (Version 5.1.0)Surgical Information Sciences, Inc. · 2021
- This deviceK223032 SIS System (Version 5.6.0)Surgical Information Sciences, Inc. · 2022
- Descendant · cites it directly · 2 of its ownK230977 SIS SystemSurgical Information Sciences, Inc. · 2023
- Descendant · 2 generations on · 1 of its ownK241083 SIS SystemSurgical Information Sciences, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK261795 Quicktome Software SuiteOmniscient Neurotechnology Pty, Ltd. · 2026
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K050438 | Stealthstation System Update | Medtronic Surgical Navigation Technologies | 2005 | 11 |
| −4 | K162830 | SIS Software | Surgical Information Sciences, Inc. | 2017 | — |
| −3 | K183019 | SIS Software version 3.3.0 | Surgical Information Sciences, Inc. | 2019 | — |
| −2 | K192304 | SIS Software Version 3.6.0 | Surgical Information Sciences, Inc. | 2019 | — |
| −1 | K210071 | SIS System (Version 5.1.0) | Surgical Information Sciences, Inc. | 2021 | — |
| 0 (this device) | K223032 | SIS System (Version 5.6.0) | Surgical Information Sciences, Inc. | 2022 | — |
| +1 | K230977 | SIS System | Surgical Information Sciences, Inc. | 2023 | — |
| +2 | K241083 | SIS System | Surgical Information Sciences, Inc. | 2024 | — |
| +3 | K261795 | Quicktome Software Suite | Omniscient Neurotechnology Pty, Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QIH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QIH device
- #1 K213998 cvi42 Auto Imaging Software Applicationscore 23.6 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K210071 | SIS System (Version 5.1.0)Summary page 4…ogical (Product Code: LLZ; 21 C.F.R 892.2050) Regulatory Class: Class II Predicate Devices Predicate: Surgical Information Sciences SIS Software version 5.1.0 (K210071) Reference: Medtronic Navigation, Inc. StealthStation System with StealthStation Cranial Software (K153… | 2021 |
| † | K153660 | StealthStation System with Cranial Software | 2016 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230977 | SIS System | 2023 | 2 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 1.6 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K230977 (Surgical Information Sciences, Inc., 2023) has gone furthest, with 2 descendants of its own.
How does its category compare?
All QIH devicesQIH Automated Radiological Image Processing Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · QIH
94in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QIH
150in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QIH
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QIH
4in 2025
MAUDE reports naming product code QIH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 11 | 145 | 0 | 0 |
| 2021 | 19 | 125 | 0 | 0 |
| 2022 | 25 | 134 | 0 | 0 |
| 2023 | 45 | 151 | 0 | 0 |
| 2024 | 64 | 141 | 0 | 2 |
| 2025 | 94 | 150 | 0 | 4 |
| 2026 | 78 | 130 | 1 | — |
What is it indicated for?
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…
Read the full statement (124 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223032 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223032: SIS System (Version 5.6.0).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223032
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026