# K081512: Stealthviz Advanced Planning Application with Stealthdti Package

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Navigation, Inc.
- Decided: Jul 18, 2008 after 49 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
No predicates in its family tree.
27 later devices descend from it; 4 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K162830: SIS Software (2017), 9 descendants of its own
- K092954: Cadstream Version 5 (2009), 8 descendants of its own
- K183019: SIS Software version 3.3.0 (2019), 6 descendants of its own
- K192304: SIS Software Version 3.6.0 (2019), 5 descendants of its own
- K210071: SIS System (Version 5.1.0) (2021), 4 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K081512
Methodology: https://510kreport.com/methodology