# K981998: Pediatric Instatrak System

- Pathway: 510(k) (Traditional)
- Applicant: Visualization Technology, Inc.
- Decided: Aug 21, 1998 after 74 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: 1 generation back to K911783 (1994). 2 ancestors in all.
327 later devices descend from it; 4 cite it directly.
9 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.
- K911783: Allegro Viewing Wand, I.S.G. Technologies, Inc. (1994) Summary page 1.

## Most influential descendants
- K983529: Instatrak 3000 (1998), 325 descendants of its own
- K994270: Instatrak 3000 System with Fluorotrak Module, Model IT3000 (2000), 294 descendants of its own
- K982994: Skull Base Instatrak System (1998), 280 descendants of its own
- K053610: Abaris (2006), 278 descendants of its own
- K121498: Percunav (2012), 222 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 Pediatric InstaTrak System is intended for image guided assistance cluring nasal surgery in pediatric patients. It is intended to be used during the treatment of acute and chronic sinusitis, endoscopic dacryocystorhinostomy, optic nerve and orbital decompression, the removal of polyps, the biopsy and removal of tumors, and the repair of CSF leaks, pituitary disorder and encephalocele.

Source page: https://510kreport.com/device/K981998
Methodology: https://510kreport.com/methodology