# K983529: Instatrak 3000

- Pathway: 510(k) (Traditional)
- Applicant: Visualization Technology, Inc.
- Decided: Dec 31, 1998 after 84 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 6 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K911783 (1994). 4 ancestors in all.
325 later devices descend from it; 5 cite it directly.
8 of 330 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960330: Instatrak, Visualization Technology, Inc. (1996) Summary page 1.
- K981998: Pediatric Instatrak System, Visualization Technology, Inc. (1998) Summary page 1.
- K954276: Stealthstation, Surgical Navigation Technologies, Inc. (1996) Summary page 1.
- K911783: Allegro Viewing Wand, I.S.G. Technologies, Inc. (1994) Summary page 1.

## Most influential descendants
- K994270: Instatrak 3000 System with Fluorotrak Module, Model IT3000 (2000), 294 descendants of its own
- K053610: Abaris (2006), 278 descendants of its own
- 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

## Recalls of this device
- Jun 22, 2009 · Class I · Z-2251-2012: GE Healthcare Surgery had discovered that using the Inverted Headset Placement is not a validated configuration with the IT 3000, 2500, 2500 plus, 3500, 3500 plus, ConneCTstat, and ConneCTstat Plus Su
- Feb 6, 2006 · Not classified · Z-0709-06: Small retaining pin may detach and fall into the surgical field during stereotactic surgery.
- Jan 26, 2005 · Not classified · Z-0704-2007: Tracking inaccuracy of 5-10 mm may result when the shunt guide accessory is used with version 5.1 software.
- Dec 13, 2004 · Not classified · Z-0689-05: Enhanced sterility testing revealed the sterilization efficacy of accessories ('Sensors') used with certain Navigation and Visualization systems may be compromised.
- Jul 12, 2004 · Not classified · Z-0814-05: Navigation inaccuracy may result if the headset registration method is used with the Axcess System Kit.
- Jul 12, 2004 · Not classified · Z-0815-05: Navigation inaccuracy may result if the headset registration method is used with the Axcess System Kit.

## Indications for use
The InstaTrak 3000 System is intended as an aid to the surgeon for precisely locating anatomical structures anywhere on the human body during either open or percutaneous procedures. It is indicated for any medical condition that may benefit from the use of stereotactic surgery and which provides a reference to rigid anatomical structures such as sinus, skull, cranial, a long bone or vertebra, visible on medical images such as CT or MR.

Source page: https://510kreport.com/device/K983529
Methodology: https://510kreport.com/methodology