510(k) · Cleared
ClearedIguide Cappa
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cas Innovations GmbH & Co. KG · JAK System, X-Ray, Tomography, Computed
Cleared on Mar 11, 2010 as substantially equivalent to K080624 (Cas Innovations AG, 2008) after a 92-day review. Its family tree reaches back 6 generations to 1994. 6 of the 51 devices in its family, counting itself, have a Class I recall.
- Decided
- Mar 11, 2010
- Review
- 92 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K911783 (1994). 50 ancestors in all, the oldest K882383 (1988). No later device cites it as a predicate yet. 6 of the 51 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK911783 Allegro Viewing WandI.S.G. Technologies, Inc. · 1994
- 5 generations backK981998 Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · Recalled (Class I)
- 4 generations backK983529 Instatrak 3000Visualization Technology, Inc. · 1998 · Recalled (Class I)
- 3 generations backK994270 Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · Recalled (Class I)
- 2 generations backK053610 AbarisTraxtal Technologies, Inc. · 2006 · Recalled
- 1 generation backK080624 Navstationirad Emt, Version 1.1Cas Innovations AG · 2008
- This deviceK093787 Iguide CappaCas Innovations GmbH & Co. KG · 2010
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K911783 | Allegro Viewing Wand | I.S.G. Technologies, Inc. | 1994 | — |
| −5 | K981998 | Pediatric Instatrak System | Visualization Technology, Inc. | 1998 | Class I |
| −4 | K983529 | Instatrak 3000 | Visualization Technology, Inc. | 1998 | Class I |
| −3 | K994270 | Instatrak 3000 System with Fluorotrak Module, Model IT3000 | Visualization Technology, Inc. | 2000 | Class I |
| −2 | K053610 | Abaris | Traxtal Technologies, Inc. | 2006 | 3 |
| −1 | K080624 | Navstationirad Emt, Version 1.1 | Cas Innovations AG | 2008 | — |
| 0 (this device) | K093787 | Iguide Cappa | Cas Innovations GmbH & Co. KG | 2010 | — |
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 |
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? (2)
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 |
|---|---|---|---|
| * | K080624 | Navstationirad Emt, Version 1.1Summary page 3…tware and hardware are identical to those of NavStationirad EMT, 013 also manufactured by CAS innovations GmbH & Co. KG and cleared by premarket ° notification number K080624. The accessory needles for biopsy and RF ablation procedures cleared by K080624 can also be used with iGuide CAPPA. The reason f… | 2008 |
| * | — | Introduction Needles and Stylets for vertebroplasty and kyphoplasty manufactured by… Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
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 · 3 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K994270Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · 3 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K983529Instatrak 3000Visualization Technology, Inc. · 1998 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K982994Skull Base Instatrak SystemVisualization Technology, Inc. · 1998 · 3 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K981998Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K960330InstatrakVisualization Technology, Inc. · 1996 · 3 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 16 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- 19 of the 50 ancestors have a recall of any class; 6 have a Class I recall.
- 1 other device also cites its predicate K080624.
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. 2010, 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?
iGuide CAPPA is intended to be an intraoperative image-guided computer-assisted navigation system for minimally invasive interventions for interventional radiology. iGuide CAPPA can be used 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…
Read the full statement (133 words)
iGuide CAPPA is intended to be an intraoperative image-guided computer-assisted navigation system for minimally invasive interventions for interventional radiology. iGuide CAPPA can be used 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 to be used in clinical applications and for anatomic structures where computer tomography or c-arm is currently used for visualizing such devices.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K093787 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093787: Iguide Cappa.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093787
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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