510(k) · Cleared
ClearedStealthConnect Remote Viewing, Planning and Collaboration System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Navigation, Inc. · HAW Neurological Stereotaxic Instrument
Cleared on Apr 21, 2017 as substantially equivalent to K153660 (Medtronic Navigation, Inc., 2016) and 2 other predicates after a 210-day review. Its family tree reaches back 12 generations to 1996. 2 of the 59 devices in its family, counting itself, have a Class I recall.
- Decided
- Apr 21, 2017
- Review
- 210 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 12 generations to K954874 (1996). 58 ancestors in all, the oldest K885054 (1989). No later device cites it as a predicate yet. 2 of the 59 devices in this family, counting this one, have a Class I recall.
- Root · 12 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 8 generations between
- 3 generations backK112930 Mobile MimMim Software, Inc. · 2011
- 2 generations backK133508 Resolutionmd MobileCalgary Scientific, Inc. · 2014
- 1 generation backK161130 ResolutionMDCalgary Scientific, Inc. · 2016
- This deviceK162655 StealthConnect Remote Viewing, Planning and Collaboration SystemMedtronic Navigation, Inc. · 2017
Show all 12 generations
- Root · 12 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 11 generations backK980914 Emory Cardiac Tool BoxEmory University · 1998
- 10 generations backK992450 Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University · 1999
- 9 generations backK014033 Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc. · 2002
- 8 generations backK040141 Emory Cardiac Toolbox Version 2.6Syntermed, Inc. · 2004
- 7 generations backK052379 Mim 3.5 (Circa)Mimvista Corp. · 2005
- 6 generations backK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- 5 generations backK062163 MimviewerMimvista Corp. · 2006
- 4 generations backK103785 Mobile MimMim Software, Inc. · 2011
- 3 generations backK112930 Mobile MimMim Software, Inc. · 2011
- 2 generations backK133508 Resolutionmd MobileCalgary Scientific, Inc. · 2014
- 1 generation backK161130 ResolutionMDCalgary Scientific, Inc. · 2016
- This deviceK162655 StealthConnect Remote Viewing, Planning and Collaboration SystemMedtronic Navigation, Inc. · 2017
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K954874 | Spectef Protocol | GE Medical Systems | 1996 | — |
| −11 | K980914 | Emory Cardiac Tool Box | Emory University | 1998 | — |
| −10 | K992450 | Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers | Emory University | 1999 | — |
| −9 | K014033 | Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers | Syntermed, Inc. | 2002 | — |
| −8 | K040141 | Emory Cardiac Toolbox Version 2.6 | Syntermed, Inc. | 2004 | — |
| −7 | K052379 | Mim 3.5 (Circa) | Mimvista Corp. | 2005 | — |
| −6 | K060816 | Mim 4.0 (Neuro | Mimvista Corp. | 2006 | 1 |
| −5 | K062163 | Mimviewer | Mimvista Corp. | 2006 | — |
| −4 | K103785 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| −3 | K112930 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| −2 | K133508 | Resolutionmd Mobile | Calgary Scientific, Inc. | 2014 | — |
| −1 | K161130 | ResolutionMD | Calgary Scientific, Inc. | 2016 | — |
| 0 (this device) | K162655 | StealthConnect Remote Viewing, Planning and Collaboration System | Medtronic Navigation, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 1 |
| 2016 | 1 | 1 |
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.
2 devices in this family have a Class I recall. 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 HAW device
- #1 K253856 Geniant Cranial (Navigated Neurosurgical…score 15.0 · 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? (3)
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 |
|---|---|---|---|
| * | K153660 | StealthStation System with Cranial SoftwareSummary page 4…eotaxic Instrument (HAW) 21 CFR 892.2050 – Picture Archiving and Communications System (LLZ) Predicate Device: K153660 – StealthStation Cranial v 3.0 (Primary) K984000 – StealthSERVER Image Storage and… | 2016 |
| * | K984000 | Stealthserver Image Storage and Communication SystemSummary page 4…re Archiving and Communications System (LLZ) Predicate Device: K153660 – StealthStation Cranial v 3.0 (Primary) K984000 – StealthSERVER Image Storage and Communication System (Secondary) K161130 – Re… | 1999 |
| * | K161130 | ResolutionMDSummary page 4…ial v 3.0 (Primary) K984000 – StealthSERVER Image Storage and Communication System (Secondary) K161130 – ResolutionMD (Secondary) Device Description: The StealthConnect™ System enables web clients on users’… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
- The line of descent spans 21 years and passes through 7 companies; a new generation was cleared every 1.9 years on median.
- 14 of the 58 ancestors have a recall of any class; 2 have a Class I recall.
- 3 other devices also cite its predicate K153660.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · HAW
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HAW
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HAW
2in 2025
Class I (9 since 2007) Class II/III not classified
Adverse event reports per year · HAW
3,425in 2025
MAUDE reports naming product code HAW, 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 | 15 | 107 | 2 | 49 |
| 2008 | 12 | 112 | 10 | 53 |
| 2009 | 8 | 221 | 6 | 96 |
| 2010 | 6 | 138 | 28 | 299 |
| 2011 | 4 | 66 | 5 | 1,725 |
| 2012 | 8 | 178 | 4 | 986 |
| 2013 | 3 | 172 | 6 (1) | 1,290 |
| 2014 | 5 | 238 | 5 | 1,606 |
| 2015 | 10 | 232 | 3 | 1,767 |
| 2016 | 9 | 175 | 5 | 1,828 |
| 2017 | 7 | 226 | 2 | 3,505 |
| 2018 | 6 | 112 | 2 (2) | 4,439 |
| 2019 | 10 | 147 | 4 (1) | 6,062 |
| 2020 | 5 | 88 | 1 | 3,480 |
| 2021 | 9 | 168 | 4 (2) | 2,827 |
| 2022 | 7 | 128 | 1 | 1,929 |
| 2023 | 14 | 142 | 4 (1) | 2,510 |
| 2024 | 7 | 107 | 2 (2) | 3,755 |
| 2025 | 9 | 163 | 2 | 3,425 |
| 2026 | 5 | 162 | 6 | — |
What is it indicated for?
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…
Read the full statement (170 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162655 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162655: StealthConnect Remote Viewing, Planning and Collaboration System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162655
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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