510(k) · Cleared
ClearedNavstationirad Emt, Version 1.1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cas Innovations AG · JAK System, X-Ray, Tomography, Computed
Cleared on Apr 11, 2008 as substantially equivalent to K053610 (Traxtal Technologies, Inc., 2006) and 3 other predicates after a 37-day review. Its family tree reaches back 5 generations to 1994. 6 of the 113 devices in its family, counting itself, have a Class I recall. 63 later devices descend from it.
- Decided
- Apr 11, 2008
- Review
- 37 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K911783 (1994). 49 ancestors in all, the oldest K882383 (1988). 63 later devices descend from it, 2 citing it directly. 6 of the 113 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK911783 Allegro Viewing WandI.S.G. Technologies, Inc. · 1994
- 4 generations backK981998 Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · Recalled (Class I)
- 3 generations backK983529 Instatrak 3000Visualization Technology, Inc. · 1998 · Recalled (Class I)
- 2 generations backK994270 Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · Recalled (Class I)
- 1 generation backK053610 AbarisTraxtal Technologies, Inc. · 2006 · Recalled
- This deviceK080624 Navstationirad Emt, Version 1.1Cas Innovations AG · 2008
- Descendant · cites it directly · 61 of its ownK092619 Etrax Needle System, Etrax Variable Angle Needle Guidance System…Civco · 2009 · Recalled
- Descendant · 2 generations on · 39 of its ownK141459 Aplio 500/400/300 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation · 2014
- Descendant · 3 generations on · 34 of its ownK151451 Aplio 500/400/300 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation · 2015 · Recalled
- Descendant · 4 generations on · 23 of its ownK161843 Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0Toshibamedical Systems Corporation · 2016 · Recalled
- Descendant · 4 generations on · 22 of its ownK163702 Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1Toshibamedical Systems Corporation · 2017 · Recalled
Showing 5 of 63 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 63 · See all- K092619Etrax Needle System, Etrax Variable Angle Needle Guidance System, Virtutrax Universal…Civco · 2009 · cites it directly61descendants
- K141459Aplio 500/400/300 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation · 2014 · 2 generations on39descendants
- K151451Aplio 500/400/300 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation · 2015 · 3 generations on34descendants
- K161843Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0Toshibamedical Systems Corporation · 2016 · 4 generations on23descendants
- K163702Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1Toshibamedical Systems Corporation · 2017 · 4 generations on22descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K911783 | Allegro Viewing Wand | I.S.G. Technologies, Inc. | 1994 | — |
| −4 | K981998 | Pediatric Instatrak System | Visualization Technology, Inc. | 1998 | Class I |
| −3 | K983529 | Instatrak 3000 | Visualization Technology, Inc. | 1998 | Class I |
| −2 | K994270 | Instatrak 3000 System with Fluorotrak Module, Model IT3000 | Visualization Technology, Inc. | 2000 | Class I |
| −1 | K053610 | Abaris | Traxtal Technologies, Inc. | 2006 | 3 |
| 0 (this device) | K080624 | Navstationirad Emt, Version 1.1 | Cas Innovations AG | 2008 | — |
| +1 | K092619 | Etrax Needle System, Etrax Variable Angle Needle Guidance System, Virtutrax… | Civco | 2009 | 17 |
| +2 | K141459 | Aplio 500/400/300 Diagnostic Ultrasound System, V5.0 | Toshibamedical Systems Corporation | 2014 | — |
| +3 | K151451 | Aplio 500/400/300 Diagnostic Ultrasound System V6.0 | Toshibamedical Systems Corporation | 2015 | 2 |
| +4 | K161843 | Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0 | Toshibamedical Systems Corporation | 2016 | 1 |
| +4 | K163702 | Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1 | Toshibamedical Systems Corporation | 2017 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 1 |
| 1997 | 2 | 0 |
| 1998 | 7 | 1 |
| 1999 | 4 | 0 |
| 2000 | 5 | 0 |
| 2001 | 7 | 0 |
| 2002 | 7 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 1 |
| 2005 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 7 | 0 |
| 2019 | 6 | 0 |
| 2020 | 8 | 0 |
| 2021 | 5 | 0 |
| 2022 | 6 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 5 | 0 |
| 2026 | 5 | 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.
6 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 JAK device
- #1 K230223 iCAC Devicescore 23.5 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K053610 | AbarisSummary page 3…lence NavStationlrad EMT is substantially equivalent to the following FDA cleared frameless stereotaxic systems: Traxtat Technologies ABARIS K053610 UltraGuide Ltd. UltraGude CT-Guide K002258 UltraGude 1000 K974432 Medtron… | 2006 |
| * | K002258 | Ultraguide CT-Guide 1010Summary page 3…ollowing FDA cleared frameless stereotaxic systems: Traxtat Technologies ABARIS K053610 UltraGuide Ltd. UltraGude CT-Guide K002258 UltraGude 1000 K974432 Medtronic StealthStation FluoroNav K990214 The dev… | 2000 |
| * | K974432 | Ultraguide 1000Summary page 3…at Technologies ABARIS K053610 UltraGuide Ltd. UltraGude CT-Guide K002258 UltraGude 1000 K974432 Medtronic StealthStation FluoroNav K990214 The device labeling contains instructions for use, the indication fo… | 1998 |
| * | K990214 | Fluoronav Module for the Stealthstation SystemSummary page 3…raGuide Ltd. UltraGude CT-Guide K002258 UltraGude 1000 K974432 Medtronic StealthStation FluoroNav K990214 The device labeling contains instructions for use, the indication for use, clinical workflow, cautions, contraindications, warn… | 1999 |
What descends from it? (63)
See all 632 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (6 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.
- K040050Instatrak System with Multiple Dataset Navigation, Model IT3500Ge Medical Systems Navigation and Visualization IN · 2004 · 2 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K994270Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · 2 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K983529Instatrak 3000Visualization Technology, Inc. · 1998 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K982994Skull Base Instatrak SystemVisualization Technology, Inc. · 1998 · 2 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K981998Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K960330InstatrakVisualization Technology, Inc. · 1996 · 2 generations back · ◆ in the 1996 ancestors bar of FIG. 11 Class I recall
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- 19 of the 49 ancestors have a recall of any class; 6 have a Class I recall.
- Of its descendants, K092619 (Civco, 2009) has gone furthest, with 61 descendants of its own.
- 6 other devices also cite its predicate K053610.
How does its category compare?
All JAK devicesJAK System, X-Ray, Tomography, Computed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · JAK
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAK
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAK
17in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAK
219in 2025
MAUDE reports naming product code JAK, 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 | 14 | 27 | 11 | 76 |
| 2008 | 26 | 42 | 16 | 120 |
| 2009 | 15 | 31 | 29 | 105 |
| 2010 | 7 | 92 | 51 | 119 |
| 2011 | 16 | 155 | 34 | 205 |
| 2012 | 28 | 121 | 23 | 192 |
| 2013 | 17 | 132 | 11 | 414 |
| 2014 | 30 | 200 | 10 | 308 |
| 2015 | 30 | 140 | 28 | 454 |
| 2016 | 25 | 129 | 44 | 365 |
| 2017 | 29 | 96 | 33 | 338 |
| 2018 | 24 | 114 | 10 | 543 |
| 2019 | 28 | 94 | 5 | 233 |
| 2020 | 30 | 112 | 8 | 177 |
| 2021 | 20 | 145 | 15 | 261 |
| 2022 | 30 | 131 | 9 | 199 |
| 2023 | 27 | 139 | 9 | 310 |
| 2024 | 26 | 141 | 20 | 212 |
| 2025 | 27 | 141 | 17 | 219 |
| 2026 | 21 | 167 | 23 | — |
What is it indicated for?
NavStationlrad EMT is intended to be an intraoperative image guided computer assisted navigation system for minimally invasive interventions for interventional radiology. NavStationlrad EMT can be used in combination with imaging systems that create a 3D-based model of the anatomy, like Computer Tomography (CT) or C-Arm systems. It displays the simulated image of a tracked device (needle) on a computer monitor screen that shows images of anatomic…
Read the full statement (135 words)
NavStationlrad EMT is intended to be an intraoperative image guided computer assisted navigation system for minimally invasive interventions for interventional radiology. NavStationlrad EMT can be used in combination with imaging systems that create a 3D-based model of the anatomy, like Computer Tomography (CT) or C-Arm systems.
It displays the simulated image of a tracked device (needle) on a computer monitor screen that shows images of anatomic relevant regions of the patient. The system also allows the planning of trajectories and displays the planning information together with the simulated image of a tracked needle on a computer monitor screen. At the same time movements of the patient are taking into account.
The device is intended for use in clinical applications and for anatomic structures where computer tomography or c-arm is currently used for visualizing such devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080624 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080624: Navstationirad Emt, Version 1.1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080624
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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