510(k) · Cleared

Recalled · 2011

Abaris

K053610510(k) TraditionalCleared Apr 19, 2006113-day reviewClass II21 CFR 892.1750Recalls 3

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Traxtal Technologies, Inc. · JAK System, X-Ray, Tomography, Computed

Cleared on Apr 19, 2006 as substantially equivalent to K023227 (Ultraguide, Ltd., 2002) and 37 other predicates after a 113-day review. Its family tree reaches back 4 generations to 1994. 8 of the 327 devices in its family, counting itself, have a Class I recall. 278 later devices descend from it. It has been recalled 3 times.

Decided: Apr 19, 2006
Review: 113 days
Class: Class II
Product code: JAK
Recalls: 3
Predicates: 39

Its longest line of descent runs back 4 generations to K911783 (1994). 48 ancestors in all, the oldest K882383 (1988). 278 later devices descend from it, 7 citing it directly. 8 of the 327 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 4 generations backK911783 Allegro Viewing WandI.S.G. Technologies, Inc. · 1994
3 generations backK981998 Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · Recalled (Class I)
2 generations backK983529 Instatrak 3000Visualization Technology, Inc. · 1998 · Recalled (Class I)
1 generation backK994270 Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · Recalled (Class I)
This deviceK053610 AbarisTraxtal Technologies, Inc. · 2006
Descendant · cites it directly · 222 of its ownK121498 PercunavPhilips Health Care · 2012
Descendant · 2 generations on · 211 of its ownK132304 Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2013 · Recalled
Descendant · 3 generations on · 100 of its ownK160807 EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound…Philips Ultrasound, Inc. · 2016 · Recalled
Descendant · 3 generations on · 87 of its ownK133833 Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2014 · Recalled
Descendant · 4 generations on · 79 of its ownK152899 Philips Lumify Diagnostic Ultrasound SystemPhilips Healthcare, Inc. · 2015 · Recalled

Showing 5 of 278 descendants. See all descendants

Descendants cleared per year

2008high 30 (2017) · low 1 (2008)2026

Class I recalls in this family

K040050 Instatrak System with Multiple Dataset…direct predicate · 2004
K994270 Instatrak 3000 System with Fluorotrak Module…direct predicate · 2000
K983529 Instatrak 3000direct predicate · 1998
K982994 Skull Base Instatrak Systemdirect predicate · 1998

Most influential descendants

Showing 5 of 278 · See all

K121498PercunavPhilips Health Care · 2012 · cites it directly222descendants
K132304Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2013 · 2 generations on211descendants
K160807EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50…Philips Ultrasound, Inc. · 2016 · 3 generations on100descendants
K133833Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2014 · 3 generations on87descendants
K152899Philips Lumify Diagnostic Ultrasound SystemPhilips Healthcare, Inc. · 2015 · 4 generations on79descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K911783	Allegro Viewing Wand	I.S.G. Technologies, Inc.	1994	—
−3	K981998	Pediatric Instatrak System	Visualization Technology, Inc.	1998	Class I
−2	K983529	Instatrak 3000	Visualization Technology, Inc.	1998	Class I
−1	K994270	Instatrak 3000 System with Fluorotrak Module, Model IT3000	Visualization Technology, Inc.	2000	Class I
0 (this device)	K053610	Abaris	Traxtal Technologies, Inc.	2006	—
+1	K121498	Percunav	Philips Health Care	2012	—
+2	K132304	Epiq Diagnostic Ultrasound System	Philips Ultrasound, Inc.	2013	36
+3	K160807	EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System…	Philips Ultrasound, Inc.	2016	33
+3	K133833	Nuvis Diagnostic Ultrasound System	Philips Ultrasound, Inc.	2014	3
+4	K152899	Philips Lumify Diagnostic Ultrasound System	Philips Healthcare, Inc.	2015	4

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
2008	1	0
2009	2	0
2010	1	0
2011	1	0
2012	3	0
2013	4	0
2014	8	0
2015	16	0
2016	16	0
2017	30	0
2018	19	0
2019	16	0
2020	27	0
2021	24	0
2022	23	0
2023	18	0
2024	19	0
2025	28	2
2026	22	0

FIG. 1 — Lineage of K053610, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) Report

What was it cleared against? (39)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
*	K023227	USG 2000SA Summary page 3 …number Ultraguide Ultraguide Ltd. K023227, K022354, K013150, K011418,…	Ultraguide, Ltd.	2002	—
*	K022354	Ultraguide CTG 2000SA Summary page 3 …number Ultraguide Ultraguide Ltd. K023227, K022354, K013150, K011418,…	Ultraguide, Ltd.	2002	—
*	K013150	MR-Guide 2000 Summary page 3 …Ultraguide Ultraguide Ltd. K023227, K022354, K013150, K011418, K002258, K974432…	Ultraguide, Ltd.	2001	—
*	K011418	Ultraguide MR-Guide 3000 Summary page 3 …Ultraguide Ultraguide Ltd. K023227, K022354, K013150, K011418, K002258, K974432 StealthS…	Ultraguide, Ltd.	2001	—
*	K002258	Ultraguide CT-Guide 1010 Summary page 3 …K013150, K011418, K002258, K974432 StealthStation System Medtronic Navigation, K050438, K043088,…	Ultraguide, Ltd.	2000	—
*	K974432	Ultraguide 1000 Summary page 3 …K013150, K011418, K002258, K974432 StealthStation System Medtronic Navigation, K050438, K043088,…	Ultraguide, Ltd.	1998	—
*	K050438	Stealthstation System Update Summary page 3 …K002258, K974432 StealthStation System Medtronic Navigation, K050438, K043088, Inc. K030552, K030106,…	Medtronic Surgical Navigation Technologies	2005	11
*	K043088	Medtronic SNT Stealthstation Axiem Imageless Knee Module Summary page 3 …K002258, K974432 StealthStation System Medtronic Navigation, K050438, K043088, Inc. K030552, K030106,…	Medtronic Surgical Navigation Technologies	2005	1
*	K030552	Imageless Knee Module for the Stealthstation System Summary page 3 …StealthStation System Medtronic Navigation, K050438, K043088, Inc. K030552, K030106, K022126, K021980,…	Medtronic Surgical Navigation Technologies	2003	1
*	K030106	Stealthstation System Advanced Contour Registration Software Module Summary page 3 …StealthStation System Medtronic Navigation, K050438, K043088, Inc. K030552, K030106, K022126, K021980,…	Medtronic Surgical Navigation Technologies	2003	—
*	K022126	Catheter Introducer for the Stealthstation System Summary page 3 …Inc. K030552, K030106, K022126, K021980, K022414, K020338,…	Medtronic Surgical Navigation Technologies	2003	—
*	K021980	Hip Module for the Stealthstation System Summary page 3 …Inc. K030552, K030106, K022126, K021980, K022414, K020338,…	Medtronic Surgical Navigation Technologies	2002	2
*	K022414	Stealthstation System Three Dimensional C-Arm Interface Summary page 3 …K022126, K021980, K022414, K020338, K012937, K003201,…	Medtronic Surgical Navigation Technologies	2002	—
*	K020338	Stealthstation with Fluoromerge Software Summary page 3 …K022126, K021980, K022414, K020338, K012937, K003201,…	Medtronic Surgical Navigation Technologies	2002	—
*	K012937	Knee Module for the Stealthstation System Summary page 3 …K022414, K020338, K012937, K003201, K001284, K992461,…	Medtronic Surgical Navigation Technologies	2002	26
*	K003201	Stealthstation Treatment Guidance Platform Summary page 3 …K022414, K020338, K012937, K003201, K001284, K992461,…	Medtronic Surgical Navigation Technologies	2000	1
*	K001284	Stealthstation System Goldeneye Micro-Magnetic Tracking System Summary page 3 …K012937, K003201, K001284, K992461, K992927, K990214,…	Medtronic Surgical Navigation Technologies	2000	28
*	K992461	Stealthstation Treatment Guidance Platform Summary page 3 …K012937, K003201, K001284, K992461, K992927, K990214,…	Surgical Navigation Technologies, Inc.	2000	—
*	K992927	Stealthstation Treatment Guidance Platform Summary page 3 …K001284, K992461, K992927, K990214, K983670, K983397,…	Surgical Navigation Technologies, Inc.	1999	2
*	K990214	Fluoronav Module for the Stealthstation System Summary page 3 …K001284, K992461, K992927, K990214, K983670, K983397,…	Surgical Navigation Technologies, Inc.	1999	29
*	K983670	Stealthstation System Summary page 3 …K992927, K990214, K983670, K983397, K981768, K981686,…	Surgical Navigation Technologies, Inc.	1999	—
*	K983397	Stealthstation Treatment Guidance Plafform Summary page 3 …K992927, K990214, K983670, K983397, K981768, K981686,…	Surgical Navigation Technologies, Inc.	1998	—
*	K981768	Stealthstation Treatment Guidance Platform Summary page 3 …K983670, K983397, K981768, K981686, K981684, K974187,…	Surgical Navigation Technologies, Inc.	1998	—
*	K981686	Stealthstation System Digitizer Change Summary page 3 …K983670, K983397, K981768, K981686, K981684, K974187,…	Surgical Navigation Technologies, Inc.	1998	—
*	K981684	Stealthstation Treatment Guidance Platform Summary page 3 …K981768, K981686, K981684, K974187, K974161, K972398,…	Surgical Navigation Technologies, Inc.	1998	—
*	K974187	Stealthstation System Summary page 3 …K981768, K981686, K981684, K974187, K974161, K972398,…	Surgical Navigation Technologies, Inc.	1998	—
*	K974161	Stealthstation System Summary page 3 …K981684, K974187, K974161, K972398, K963 173, K954276…	Surgical Navigation Technologies, Inc.	1997	—
*	K972398	Stealthstation Passive Instrument Option Summary page 3 …K981684, K974187, K974161, K972398, K963 173, K954276 CBYON S…	Surgical Navigation Technologies, Inc.	1997	1
*	K963173	Stealthstation System Summary page 3 …K974161, K972398, K963 173, K954276 CBYON Surgical Operating Cbyon, Inc. K1000171, K012886…	Surgical Navigation Technologies, Inc.	1996	—
*	K954276	Stealthstation Summary page 3 …K974161, K972398, K963 173, K954276 CBYON Surgical Operating Cbyon, Inc. K1000171, K012886 System…	Surgical Navigation Technologies, Inc.	1996	1
Kept off the family tree	K100171	CBYON Surgical Operating System Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree
*	K012886	Cbyon System with Image Enhanced Fluoroscopy Module Summary page 3 …K963 173, K954276 CBYON Surgical Operating Cbyon, Inc. K1000171, K012886 System Instatrak GE Medical Systems K960330, K981998,…	Cbyon, Inc.	2001	—
*	K960330	Instatrak Summary page 3 …erating Cbyon, Inc. K1000171, K012886 System Instatrak GE Medical Systems K960330, K981998, Navigation and K982994, K983529,…	Visualization Technology, Inc.	1996	Class I
*	K981998	Pediatric Instatrak System Summary page 3 …Cbyon, Inc. K1000171, K012886 System Instatrak GE Medical Systems K960330, K981998, Navigation and K982994, K983529,…	Visualization Technology, Inc.	1998	Class I
*	K982994	Skull Base Instatrak System Summary page 3 …Instatrak GE Medical Systems K960330, K981998, Navigation and K982994, K983529, Visualization K994270,K0035 10,…	Visualization Technology, Inc.	1998	Class I
*	K983529	Instatrak 3000 Summary page 3 …Instatrak GE Medical Systems K960330, K981998, Navigation and K982994, K983529, Visualization K994270,K0035 10,…	Visualization Technology, Inc.	1998	Class I
*	K994270	Instatrak 3000 System with Fluorotrak Module, Model IT3000 Summary page 3 …Navigation and K982994, K983529, Visualization K994270,K0035 10, K040050 The device…	Visualization Technology, Inc.	2000	Class I
*	K003510	Instatrak System with Fluorocat, Model IT3500 Summary page 3 …Navigation and K982994, K983529, Visualization K994270,K0035 10, K040050 The device labeling…	Visualization Technology, Inc.	2001	2
*	K040050	Instatrak System with Multiple Dataset Navigation, Model IT3500 Summary page 3 …Visualization K994270,K0035 10, K040050 The device labeling contains instructions for use. It includes indications for use, cautio…	Ge Medical Systems Navigation and Visualization IN	2004	Class I

Also cleared against K023227: 1 other device →

What descends from it? (278)

See all 278

7 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K121498	Percunav	Philips Health Care	2012	222
K080624	Navstationirad Emt, Version 1.1	Cas Innovations AG	2008	63
K092619	Etrax Needle System, Etrax Variable Angle Needle Guidance System, Virtutrax Universal…	Civco	2009	61
K093672	Aegis Navigation Anda Egis Pelvic Application	Sentinelle Medical, Inc.	2009	8
K120187	Multi-Modality Image Fusion	Igt, LLC Dba Eigen	2012	4
K151414	IQQA Guide	Edda Technology	2015	1
K133901	Pari-Path Surgical Navigation System	Paritic, Inc.	2014	0

Has anything in its family been recalled? (8 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jun 1, 2011	Not classified	Z-2769-2011	Nonconforming Material/Component	PercuNav Tool Connection Unit may contain an electronic component that does not meet specification, which could cause registration difficulties and/or inaccurate instrument tracking.
Apr 1, 2011	Not classified	Z-2219-2011	Device Design	The PercuNav Field Generator Stand could tip over during set up, during use, or during transport.
Nov 10, 2010	Not classified	Z-0617-2011	Other	The protective cover over the tip of the MP008R-B Button Probe may fall off, causing the probe tip to damage the packaging and compromise the sterility of the probe.

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 · Direct predicate · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
K994270Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · Direct predicate · ◆ on the line of descent in FIG. 12 Class I recalls
K983529Instatrak 3000Visualization Technology, Inc. · 1998 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
K982994Skull Base Instatrak SystemVisualization Technology, Inc. · 1998 · Direct predicate · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
K981998Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
K960330InstatrakVisualization Technology, Inc. · 1996 · Direct predicate · ◆ in the 1996 ancestors bar of FIG. 11 Class I recall
K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 7 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 7 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 12 years and passes through 3 companies; a new generation was cleared every 4.4 years on median.
18 of the 48 ancestors have a recall of any class; 6 have a Class I recall.
Of its descendants, K121498 (Philips Health Care, 2012) has gone furthest, with 222 descendants of its own.
1 other device also cites its predicate K023227.

How does its category compare?

All JAK devices

JAK System, X-Ray, Tomography, Computed: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JAK

27in 2025

2007high 30 (2014) · low 7 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JAK

141in 2025

2007high 200 (2014) · low 27 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JAK

17in 2025

2007high 51 (2010) · low 5 (2019)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JAK

219in 2025

2007high 543 (2018) · low 76 (2007)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?

Read the full statement (155 words)

ABARIS is a stereotaxic accessory for Computed Tomography (CT), Magnetic Resonance, (MR), Ultrasound (US), Positron Emission Tomography (PET), Single Photon Emission Computed Tomography (SPECT), Fluoroscopy, Endoscopy and other imaging systems. It displays 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 movements of the patient. This is intended for treatment planning and intra-operative guidance for surgical 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 clinical interventions and for anatomical structures where imaging is currently used for visualizing such procedures. The device is also intended for use in clinical interventions to determine the proximity of one device relative to another.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K053610 · printed Nov 6, 2026

Cite this page

510(k) Report. “K053610: Abaris.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053610

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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