510(k) · Cleared
ClearedSIS Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgical Information Sciences, Inc. · LLZ System, Image Processing, Radiological
Cleared on Feb 14, 2017 as substantially equivalent to K050438 (Medtronic Surgical Navigation Technologies, 2005) and 1 other predicate after a 130-day review. Its family tree reaches back 1 generation to 2005. 9 later devices descend from it.
- Decided
- Feb 14, 2017
- Review
- 130 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K050438 (2005). 2 ancestors in all. 9 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK050438 Stealthstation System UpdateMedtronic Surgical Navigation Technologies · 2005 · Recalled
- This deviceK162830 SIS SoftwareSurgical Information Sciences, Inc. · 2017
- Descendant · cites it directly · 6 of its ownK183019 SIS Software version 3.3.0Surgical Information Sciences, Inc. · 2019
- Descendant · 2 generations on · 5 of its ownK192304 SIS Software Version 3.6.0Surgical Information Sciences, Inc. · 2019
- Descendant · 3 generations on · 4 of its ownK210071 SIS System (Version 5.1.0)Surgical Information Sciences, Inc. · 2021
- Descendant · 4 generations on · 3 of its ownK223032 SIS System (Version 5.6.0)Surgical Information Sciences, Inc. · 2022
- Descendant · 5 generations on · 2 of its ownK230977 SIS SystemSurgical Information Sciences, Inc. · 2023
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K183019SIS Software version 3.3.0Surgical Information Sciences, Inc. · 2019 · cites it directly6descendants
- K192304SIS Software Version 3.6.0Surgical Information Sciences, Inc. · 2019 · 2 generations on5descendants
- K210071SIS System (Version 5.1.0)Surgical Information Sciences, Inc. · 2021 · 3 generations on4descendants
- K223032SIS System (Version 5.6.0)Surgical Information Sciences, Inc. · 2022 · 4 generations on3descendants
- K230977SIS SystemSurgical Information Sciences, Inc. · 2023 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K050438 | Stealthstation System Update | Medtronic Surgical Navigation Technologies | 2005 | 11 |
| 0 (this device) | K162830 | SIS Software | Surgical Information Sciences, Inc. | 2017 | — |
| +1 | 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 | — |
| +3 | K210071 | SIS System (Version 5.1.0) | Surgical Information Sciences, Inc. | 2021 | — |
| +4 | K223032 | SIS System (Version 5.6.0) | Surgical Information Sciences, Inc. | 2022 | — |
| +5 | K230977 | SIS System | Surgical Information Sciences, Inc. | 2023 | — |
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 |
|---|---|---|
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 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 LLZ? 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 LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K050438 | Stealthstation System UpdateSummary page 4…ation Name Picture Archiving and Communication System (Product Code: LLZ; 21 C.F.R. 892.2050) Predicate and Reference Devices Medtronic’s StealthStation (K050438) Medtronic’s Stealth Viz Advanced Planning Application with StealthDTI Package (K081512) Brainreader ApS’ Neuroread… | 2005 |
| * | K081512 | Stealthviz Advanced Planning Application with Stealthdti PackageSummary page 4…2050) Predicate and Reference Devices Medtronic’s StealthStation (K050438) Medtronic’s Stealth Viz Advanced Planning Application with StealthDTI Package (K081512) Brainreader ApS’ Neuroreader Image Processing Software (K140828) (Reference device) Intended Use / Indications for Use… | 2008 |
| † | K140828 | Neuroreader Medical Image Processing Software | 2015 |
What descends from it? (9)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, 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 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162830 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162830: SIS Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162830
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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