510(k) · Cleared
ClearedPercunav
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Health Care · JAK System, X-Ray, Tomography, Computed
Cleared on Dec 14, 2012 as substantially equivalent to K053610 (Traxtal Technologies, Inc., 2006) after a 207-day review. Its family tree reaches back 5 generations to 1994. 8 of the 272 devices in its family, counting itself, have a Class I recall. 222 later devices descend from it.
- Decided
- Dec 14, 2012
- Review
- 207 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K911783 (1994). 49 ancestors in all, the oldest K882383 (1988). 222 later devices descend from it, 2 citing it directly. 8 of the 272 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 deviceK121498 PercunavPhilips Health Care · 2012
- Descendant · cites it directly · 211 of its ownK132304 Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 100 of its ownK160807 EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound…Philips Ultrasound, Inc. · 2016 · Recalled
- Descendant · 2 generations on · 87 of its ownK133833 Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2014 · Recalled
- Descendant · 3 generations on · 79 of its ownK152899 Philips Lumify Diagnostic Ultrasound SystemPhilips Healthcare, Inc. · 2015 · Recalled
- Descendant · 2 generations on · 58 of its ownK163120 EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound…Philips Ultrasound, Inc. · 2017 · Recalled
Showing 5 of 222 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 222 · See all- K132304Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2013 · cites it directly211descendants
- K160807EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50…Philips Ultrasound, Inc. · 2016 · 2 generations on100descendants
- K133833Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2014 · 2 generations on87descendants
- K152899Philips Lumify Diagnostic Ultrasound SystemPhilips Healthcare, Inc. · 2015 · 3 generations on79descendants
- K163120EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50…Philips Ultrasound, Inc. · 2017 · 2 generations on58descendants
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) | K121498 | Percunav | Philips Health Care | 2012 | — |
| +1 | K132304 | Epiq Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2013 | 36 |
| +2 | K160807 | EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System… | Philips Ultrasound, Inc. | 2016 | 33 |
| +2 | K133833 | Nuvis Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2014 | 3 |
| +3 | K152899 | Philips Lumify Diagnostic Ultrasound System | Philips Healthcare, Inc. | 2015 | 4 |
| +2 | K163120 | EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System… | Philips Ultrasound, Inc. | 2017 | 28 |
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 |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 13 | 0 |
| 2016 | 14 | 0 |
| 2017 | 25 | 0 |
| 2018 | 12 | 0 |
| 2019 | 12 | 0 |
| 2020 | 23 | 0 |
| 2021 | 19 | 0 |
| 2022 | 20 | 0 |
| 2023 | 15 | 0 |
| 2024 | 19 | 0 |
| 2025 | 25 | 2 |
| 2026 | 19 | 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.
8 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 |
|---|---|---|---|
| * | K053610 | AbarisSummary page 2…currently approved Indications for Use cleared for the PercuNav predicate device. The PercuNav System, originally named "Abaris" (K053610, cleared April 16, 2006) is currently marketed by Philips Healthcare. The manufacturer Traxtal Inc. was… | 2006 |
What descends from it? (222)
See all 2222 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (8 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
- K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 6 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
- K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 6 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
Nearest 5 of 8; all are on the web page.
What does this lineage say?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 4.4 years on median.
- 19 of the 49 ancestors have a recall of any class; 6 have a Class I recall.
- Of its descendants, K132304 (Philips Ultrasound, Inc., 2013) has gone furthest, with 211 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. 2012, 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?
PercuNav is a stereotaxic accessory for Computed Tomography (CT), Magnetic Resonance (MR), Ultrasound (US), Positron Emission Tomography (PET), Single Photon Emission Computed Tomography (SPECT), Rotational Fluoroscopy, Endoscopy, and other imaging systems. CT, Ultrasound, PET, MR, and Rotational Fluoroscopy may be fused in various combinations, such as CT with MR, MR with ultrasound, etc. It may include instrumentation to display the simulated image of…
Read the full statement (506 words)
PercuNav is a stereotaxic accessory for Computed Tomography (CT), Magnetic Resonance (MR), Ultrasound (US), Positron Emission Tomography (PET), Single Photon Emission Computed Tomography (SPECT), Rotational Fluoroscopy, Endoscopy, and other imaging systems. CT, Ultrasound, PET, MR, and Rotational Fluoroscopy may be fused in various combinations, such as CT with MR, MR with ultrasound, etc. It may include instrumentation to display the simulated image of a tracked insertion tool such as a biopsy needle, guidewire 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 taking into account patient movement. This is intended for treatment planning and guidance for clinical, interventional, and/or diagnostic procedures. The device also supports an image-free mode in which the proximity of the mnterventional device is displayed relative to another device.
The device is intended to be used in interventional and diagnostic procedures in a clinical setting. The device is also intended for use in clinical interventions to detennine the proximity of one device relative to another. Example procedures include, but are not limited to:
* Image fusion for diagnostic clinical examinations and procedures
* Soft tissue biopsies (liver, lung, kidney, breast, pancreas, bladder, adrenal glands, lymph node, mesentery, etc.)
* Soft tissue ablation (liver, kidney, breast, pancreas,, lung, etc.)
* Bone ablation
* Bone biopsies
* Nerve Blocks & Pain Management
* Drainage placements
* Hydrodissections
* Bladder Stimulation
* Fiducial placements
* Tumor resections
* Sinus procedures
* Intranasal procedures
* Transphenoidal procedures
PercuNav is a stereotaxic accessory for Computed Tomography (CT), Magnetic Resonance (MR), Ultrasound (US), Positron Emission Tomography (PET), Single Photon Emission Computed Tomography (SPECT), Rotational Fluoroscopy, Endoscopy, and other imaging systems. CT, Ultrasound, PET, MR, and Rotational Fluoroscopy may be fused in various combinations, such as CT with NM, MR with ultrasound, etc. It may include instrumentation to display the simulated image of a tracked insertion tool such as a biopsy needle, guidewire 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 instnrment taking into account patient movement. This is intended for treatment planning and guidance for clinical, interventional, and/or diagnostic procedures. The device also supports an image-free mode in which the proximity of the interventional device is displayed relative to another device.
The device is intended to be used in interventional and diagnostic procedures in a clinical setting. The device is also intended for use in clinical interventions to determine the proximity of one device relative to another. Example procedures include, but are not limited to:
* Image fusion for diagnostic clinical examinations and procedures
* Soft tissue biopsies (liver, lung, kidney, breast, pancreas, bladder, adrenal glands, lymph node, mesentery, etc.)
* Soft tissue ablation (liver, kidney, breast, pancreas,, lung, etc.)
* Bone ablation
* Bone biopsies
* Nerve Blocks & Pain Management
* Drainage placements
* Hydrodissections
* Bladder Stimulation
* Fiducial placements
* Tumor resections
* Sinus procedures
* Intranasal procedures
* Transphenoidal procedures
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121498 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121498: Percunav.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121498
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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