# K162655: StealthConnect Remote Viewing, Planning and Collaboration System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Navigation, Inc.
- Decided: Apr 21, 2017 after 210 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K954874 (1996). 58 ancestors in all.
No later device cites it as a predicate yet.
2 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153660: StealthStation System with Cranial Software, Medtronic Navigation, Inc. (2016) Summary page 4.
- K984000: Stealthserver Image Storage and Communication System, Surgical Navigation Technologies, Inc. (1999) Summary page 4.
- K161130: ResolutionMD, Calgary Scientific, Inc. (2016) Summary page 4.

## Indications for use
The StealthConnect® System is web-based software to remotely access the StealthStation® Cranial software for viewing, stereotactic surgery planning and collaborating by trained professionals such as physicians, technologists and nurses. The StealthConnect® system has not been validated for primary diagnostic reading of Digital Imaging and Communications in Medicine (DICOM) images. The StealthConnect® Remote Viewing, Planning and Collaboration System is an accessory to the StealthStation® System. It provides a web- based client interface to securely access encrypted storage of DICOM-compliant images via a LAN, and/or the internet using general-purpose computers, and by one or more authorized people. It provides for communication, storage, reformatting, rendering, and display of DICOM 3.0 compliant image data derived from various sources including CT and MRI. In addition, the system provides access to the surgical planning aspects of StealthStation® software, and can be used to set or review surgical plans for stereotactic surgeries that are compatible with and can be transferred to a StealthStation® System or any DICOM-compliant PACS system. StealthConnect® is not to be used for mammography.

Source page: https://510kreport.com/device/K162655
Methodology: https://510kreport.com/methodology