510(k) · Cleared
ClearedStealthviz Advanced Planning Application with Stealthdti Package
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Navigation, Inc. · LLZ System, Image Processing, Radiological
Cleared on Jul 18, 2008 after a 49-day review. The FDA summary names no predicate by number. 27 later devices descend from it.
- Decided
- Jul 18, 2008
- Review
- 49 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 0
27 later devices descend from it, 4 citing it directly.
- This deviceK081512 Stealthviz Advanced Planning Application with Stealthdti PackageMedtronic Navigation, Inc. · 2008
- Descendant · cites it directly · 9 of its ownK162830 SIS SoftwareSurgical Information Sciences, Inc. · 2017
- Descendant · cites it directly · 8 of its ownK092954 Cadstream Version 5Confirma, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 6 of its ownK183019 SIS Software version 3.3.0Surgical Information Sciences, Inc. · 2019
- Descendant · 3 generations on · 5 of its ownK192304 SIS Software Version 3.6.0Surgical Information Sciences, Inc. · 2019
- Descendant · 4 generations on · 4 of its ownK210071 SIS System (Version 5.1.0)Surgical Information Sciences, Inc. · 2021
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K162830SIS SoftwareSurgical Information Sciences, Inc. · 2017 · cites it directly9descendants
- K092954Cadstream Version 5Confirma, Inc. · 2009 · cites it directly8descendants
- K183019SIS Software version 3.3.0Surgical Information Sciences, Inc. · 2019 · 2 generations on6descendants
- K192304SIS Software Version 3.6.0Surgical Information Sciences, Inc. · 2019 · 3 generations on5descendants
- K210071SIS System (Version 5.1.0)Surgical Information Sciences, Inc. · 2021 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K081512 | Stealthviz Advanced Planning Application with Stealthdti Package | Medtronic Navigation, Inc. | 2008 | — |
| +1 | K162830 | SIS Software | Surgical Information Sciences, Inc. | 2017 | — |
| +1 | K092954 | Cadstream Version 5 | Confirma, Inc. | 2009 | 3 |
| +2 | K183019 | SIS Software version 3.3.0 | Surgical Information Sciences, Inc. | 2019 | — |
| +3 | K192304 | SIS Software Version 3.6.0 | Surgical Information Sciences, Inc. | 2019 | — |
| +4 | K210071 | SIS System (Version 5.1.0) | Surgical Information Sciences, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 5 | 0 |
| 2024 | 6 | 0 |
| 2025 | 3 | 0 |
| 2026 | 4 | 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?
The FDA summary names no predicate by number.
What descends from it? (27)
See all 274 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?
- Of its descendants, K162830 (Surgical Information Sciences, Inc., 2017) has gone furthest, with 9 descendants of its own.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
StealthViz is a software application indicated for use in 2D/3D surgical planning and image review and analysis. It enables: * importing digital diagnostic and functional imaging datasets (e.g. MR, MRA, CT, CTA, fMRI, X-ray, DSA, PET, SPECT, MEG, MSI, * reviewing and analyzing the data in various 2D and 3D presentation formats, * performing image fusion (co-registration) of datasets, * segmenting structures in the images with manual and automatic tools…
Read the full statement (175 words)
StealthViz is a software application indicated for use in 2D/3D surgical planning and image review and analysis. It enables:
* importing digital diagnostic and functional imaging datasets (e.g. MR, MRA, CT, CTA, fMRI, X-ray, DSA, PET, SPECT, MEG, MSI,
* reviewing and analyzing the data in various 2D and 3D presentation formats,
* performing image fusion (co-registration) of datasets,
* segmenting structures in the images with manual and automatic tools and converting them into 3D objects for display,
* exporting results to other Medtronic Navigation planning applications, to a PACS or to Medtronic Navigation surgical navigation systems such as the StealthStation System.
The StealthDTI Package is a subset of StealthViz that implements a special case of segmenting 3D structures from the datasets. It is indicated for use in the processing of diffusion-weighted MRI sequences into 3D objects that represent white-matter tracts.
Only DICOM for presentation images can be used on an FDA approved monitor for mammography for primary image diagnosis. Only uncompressed or non-lossy compressed images must be used for primary image diagnosis in mammography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081512 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081512: Stealthviz Advanced Planning Application with Stealthdti Package.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081512
Report an extraction error
Are you the manufacturer?
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