# K053610: Abaris - Pathway: 510(k) (Traditional) - Applicant: Traxtal Technologies, Inc. - Decided: Apr 19, 2006 after 113 days - Product code: JAK (System, X-Ray, Tomography, Computed) - Device class: 2 - Regulation: 21 CFR 892.1750 - Recalls of this device: 3 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 4 generations back to K911783 (1994). 48 ancestors in all. 278 later devices descend from it; 7 cite it directly. 8 of 327 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K023227: USG 2000SA, Ultraguide, Ltd. (2002) Summary page 3. - K022354: Ultraguide CTG 2000SA, Ultraguide, Ltd. (2002) Summary page 3. - K013150: MR-Guide 2000, Ultraguide, Ltd. (2001) Summary page 3. - K011418: Ultraguide MR-Guide 3000, Ultraguide, Ltd. (2001) Summary page 3. - K002258: Ultraguide CT-Guide 1010, Ultraguide, Ltd. (2000) Summary page 3. - K974432: Ultraguide 1000, Ultraguide, Ltd. (1998) Summary page 3. - K050438: Stealthstation System Update, Medtronic Surgical Navigation Technologies (2005) Summary page 3. - K043088: Medtronic SNT Stealthstation Axiem Imageless Knee Module, Medtronic Surgical Navigation Technologies (2005) Summary page 3. - K030552: Imageless Knee Module for the Stealthstation System, Medtronic Surgical Navigation Technologies (2003) Summary page 3. - K030106: Stealthstation System Advanced Contour Registration Software Module, Medtronic Surgical Navigation Technologies (2003) Summary page 3. - K022126: Catheter Introducer for the Stealthstation System, Medtronic Surgical Navigation Technologies (2003) Summary page 3. - K021980: Hip Module for the Stealthstation System, Medtronic Surgical Navigation Technologies (2002) Summary page 3. - K022414: Stealthstation System Three Dimensional C-Arm Interface, Medtronic Surgical Navigation Technologies (2002) Summary page 3. - K020338: Stealthstation with Fluoromerge Software, Medtronic Surgical Navigation Technologies (2002) Summary page 3. - K012937: Knee Module for the Stealthstation System, Medtronic Surgical Navigation Technologies (2002) Summary page 3. - K003201: Stealthstation Treatment Guidance Platform, Medtronic Surgical Navigation Technologies (2000) Summary page 3. - K001284: Stealthstation System Goldeneye Micro-Magnetic Tracking System, Medtronic Surgical Navigation Technologies (2000) Summary page 3. - K992461: Stealthstation Treatment Guidance Platform, Surgical Navigation Technologies, Inc. (2000) Summary page 3. - K992927: Stealthstation Treatment Guidance Platform, Surgical Navigation Technologies, Inc. (1999) Summary page 3. - K990214: Fluoronav Module for the Stealthstation System, Surgical Navigation Technologies, Inc. (1999) Summary page 3. - K983670: Stealthstation System, Surgical Navigation Technologies, Inc. (1999) Summary page 3. - K983397: Stealthstation Treatment Guidance Plafform, Surgical Navigation Technologies, Inc. (1998) Summary page 3. - K981768: Stealthstation Treatment Guidance Platform, Surgical Navigation Technologies, Inc. (1998) Summary page 3. - K981686: Stealthstation System Digitizer Change, Surgical Navigation Technologies, Inc. (1998) Summary page 3. - K981684: Stealthstation Treatment Guidance Platform, Surgical Navigation Technologies, Inc. (1998) Summary page 3. - K974187: Stealthstation System, Surgical Navigation Technologies, Inc. (1998) Summary page 3. - K974161: Stealthstation System, Surgical Navigation Technologies, Inc. (1997) Summary page 3. - K972398: Stealthstation Passive Instrument Option, Surgical Navigation Technologies, Inc. (1997) Summary page 3. - K963173: Stealthstation System, Surgical Navigation Technologies, Inc. (1996) Summary page 3. - K954276: Stealthstation, Surgical Navigation Technologies, Inc. (1996) Summary page 3. - K012886: Cbyon System with Image Enhanced Fluoroscopy Module, Cbyon, Inc. (2001) Summary page 3. - K960330: Instatrak, Visualization Technology, Inc. (1996) Summary page 3. - K981998: Pediatric Instatrak System, Visualization Technology, Inc. (1998) Summary page 3. - K982994: Skull Base Instatrak System, Visualization Technology, Inc. (1998) Summary page 3. - K983529: Instatrak 3000, Visualization Technology, Inc. (1998) Summary page 3. - K994270: Instatrak 3000 System with Fluorotrak Module, Model IT3000, Visualization Technology, Inc. (2000) Summary page 3. - K003510: Instatrak System with Fluorocat, Model IT3500, Visualization Technology, Inc. (2001) Summary page 3. - K040050: Instatrak System with Multiple Dataset Navigation, Model IT3500, Ge Medical Systems Navigation and Visualization IN (2004) Summary page 3. ## Cited in the summary but 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 ## Most influential descendants - K121498: Percunav (2012), 222 descendants of its own - K132304: Epiq Diagnostic Ultrasound System (2013), 211 descendants of its own - K160807: EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System (2016), 100 descendants of its own - K133833: Nuvis Diagnostic Ultrasound System (2014), 87 descendants of its own - K152899: Philips Lumify Diagnostic Ultrasound System (2015), 79 descendants of its own ## Recalls of this device - Jun 1, 2011 · Not classified · Z-2769-2011: 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: The PercuNav Field Generator Stand could tip over during set up, during use, or during transport. - Nov 10, 2010 · Not classified · Z-0617-2011: 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. ## Indications for use 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. Source page: https://510kreport.com/device/K053610 Methodology: https://510kreport.com/methodology