510(k) · Cleared
ClearedPercuNav Image Fusion and Interventional Navigation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Ultrasound, Inc. · JAK System, X-Ray, Tomography, Computed
Cleared on May 14, 2020 as substantially equivalent to K170716 (Philips Ultrasound, Inc., 2017) after a 23-day review. Its family tree reaches back 8 generations to 1994. 6 of the 54 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- May 14, 2020
- Review
- 23 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K911783 (1994). 52 ancestors in all, the oldest K882383 (1988). 1 later device descends from it, 1 citing it directly. 6 of the 54 devices in this family, counting this one, have a Class I recall.
- Root · 8 generations backK911783 Allegro Viewing WandI.S.G. Technologies, Inc. · 1994
- 7 generations backK981998 Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · Recalled (Class I)
- 6 generations backK983529 Instatrak 3000Visualization Technology, Inc. · 1998 · Recalled (Class I)
- 5 generations backK994270 Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · Recalled (Class I)
- 4 generations backK053610 AbarisTraxtal Technologies, Inc. · 2006 · Recalled
- 3 generations backK121498 PercunavPhilips Health Care · 2012
- 2 generations backK132087 Percunav SystemPhilips Health Care · 2013
- 1 generation backK170716 PercuNav Image Fusion and Interventional NavigationPhilips Ultrasound, Inc. · 2017
- This deviceK201053 PercuNav Image Fusion and Interventional NavigationPhilips Ultrasound, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK223804 PercuNav Image Fusion and Interventional Navigation SystemPhilips Ultrasound, LLC · 2023
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K223804PercuNav Image Fusion and Interventional Navigation SystemPhilips Ultrasound, LLC · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K911783 | Allegro Viewing Wand | I.S.G. Technologies, Inc. | 1994 | — |
| −7 | K981998 | Pediatric Instatrak System | Visualization Technology, Inc. | 1998 | Class I |
| −6 | K983529 | Instatrak 3000 | Visualization Technology, Inc. | 1998 | Class I |
| −5 | K994270 | Instatrak 3000 System with Fluorotrak Module, Model IT3000 | Visualization Technology, Inc. | 2000 | Class I |
| −4 | K053610 | Abaris | Traxtal Technologies, Inc. | 2006 | 3 |
| −3 | K121498 | Percunav | Philips Health Care | 2012 | — |
| −2 | K132087 | Percunav System | Philips Health Care | 2013 | — |
| −1 | K170716 | PercuNav Image Fusion and Interventional Navigation | Philips Ultrasound, Inc. | 2017 | — |
| 0 (this device) | K201053 | PercuNav Image Fusion and Interventional Navigation | Philips Ultrasound, Inc. | 2020 | — |
| +1 | K223804 | PercuNav Image Fusion and Interventional Navigation System | Philips Ultrasound, LLC | 2023 | — |
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 |
|---|---|---|
| 2023 | 1 | 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? (1)
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 |
|---|---|---|---|
| * | K170716 | PercuNav Image Fusion and Interventional NavigationSummary page 6…r later procedures. 5. Substantially Equivalent Devices Primary Predicate Device Philips PercuNav Image Fusion an Interventional Navigation System K170716 April 21, 2017 Reference Predicate Device 3 === Page 7 ==… | 2017 |
| † | K191647 | QLAB Advanced Quantification Software | 2019 |
| † | K093995 | IG 4 Image Guided System | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223804 | PercuNav Image Fusion and Interventional Navigation System | 2023 | 0 |
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 · 5 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K994270Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · 5 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K983529Instatrak 3000Visualization Technology, Inc. · 1998 · 5 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K982994Skull Base Instatrak SystemVisualization Technology, Inc. · 1998 · 5 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K981998Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · 5 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K960330InstatrakVisualization Technology, Inc. · 1996 · 5 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 26 years and passes through 5 companies; a new generation was cleared every 3.7 years on median.
- 19 of the 52 ancestors have a recall of any class; 6 have a Class I recall.
- Of its descendants, K223804 (Philips Ultrasound, LLC, 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K170716.
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. 2020, 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?
The PercuNav system is a stereotaxic accessory for computed tomography (CT), cone beam CT (CBCT), magnetic resonance (MR), ultrasound (US), and positron emission tomography (PET). CT, Ultrasound, PET, and MR may be fused in various combinations, such as CT with MR, MR with ultrasound, and so on. It may include instrumentation to display the simulated image of a tracked insertion tool such as a biopsy needle or probe on a computer monitor screen that…
Read the full statement (201 words)
The PercuNav system is a stereotaxic accessory for computed tomography (CT), cone beam CT (CBCT), magnetic resonance (MR), ultrasound (US), and positron emission tomography (PET). CT, Ultrasound, PET, and MR may be fused in various combinations, such as CT with MR, MR with ultrasound, and so on. It may include instrumentation to display the simulated image of a tracked insertion tool such as a biopsy needle or probe on a computer monitor screen that shows images of the target organs and the current and the projected future path of the interventional instrument. The PercuNav system is intended for treatment planning and to assist guidance for clinical, interventional, or diagnostic procedures in a clinical setting.
The PercuNav system is also intended to supplement live imaging in clinical interventions to determine the proximity of one device relative to another.
The PercuNav system is not intended to be the sole guidance for any procedure. Procedures that can be guided by the PercuNav system adjunctively include, but are not limited to, the following:
• Image fusion for diagnostic clinical examinations and procedures
• Soft tissue biopsies
• Soft tissue ablation
• Bone ablation
• Bone biopsies
• Nerve blocks and pain management
• Drainage placements
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201053 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201053: PercuNav Image Fusion and Interventional Navigation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201053
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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