# K982994: Skull Base Instatrak System

- Pathway: 510(k) (Traditional)
- Applicant: Visualization Technology, Inc.
- Decided: Nov 16, 1998 after 81 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 1 (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). 3 ancestors in all.
280 later devices descend from it; 2 cite it directly.
6 of 284 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.
- K911783: Allegro Viewing Wand, I.S.G. Technologies, Inc. (1994) Summary page 1.

## Most influential descendants
- 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
- K133833: Nuvis Diagnostic Ultrasound System (2014), 87 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

## Indications for use
The Skull Based InstaTrak System is intended for image guided assistance during skull base surgical procedures. It is intended to be used during skull base surgery involving procedures on the base of the brain (junction of the face and neurocranium).

Source page: https://510kreport.com/device/K982994
Methodology: https://510kreport.com/methodology