# K960330: Instatrak

- Pathway: 510(k) (Traditional)
- Applicant: Visualization Technology, Inc.
- Decided: Apr 8, 1996 after 75 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 9 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
328 later devices descend from it; 8 cite it directly.
9 of 329 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Viewing Wand: named in the summary without a submission number
- (no number) Barnes Suction Tube: named in the summary without a submission number

## Most influential descendants
- K981998: Pediatric Instatrak System (1998), 327 descendants of its own
- 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

## Recalls of this device
- Nov 26, 2013 · Class II · Z-0524-2014: GE OEC Medical Systems Inc is recalling InstaTrak 3500 Plus, ENTrakTM Plus, InstaTrak 3500, ENTrakTM Computer-Assisted Navigation Systems (USA) due to several potential safety issues related to the us
- 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
- Oct 18, 2007 · Not classified · Z-0183-2008: Crack, Fracture or Detachment: The Transmitter Arm for the Mayfield-compatible Transmitter may become detached from the unit and enter into the surgical field.
- May 18, 2007 · Not classified · Z-1130-2007: Cleaning probes used to unclog disposable aspirators may shed small particles of nylon material which may be transferred into the nasal cavity.
- Dec 13, 2004 · Not classified · Z-0687-05: Enhanced sterility testing revealed the sterilization efficacy of accessories ('Sensors') used with certain Navigation and Visualization systems may be compromised.
- Dec 13, 2004 · Not classified · Z-0688-05: 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-0813-05: Navigation inaccuracy may result if the headset registration method is used with the Axcess System Kit.
- Jul 12, 2004 · Not classified · Z-0812-05: Navigation inaccuracy may result if the headset registration method is used with the Axcess System Kit.
- Jul 12, 2004 · Not classified · Z-0814-05: Navigation inaccuracy may result if the headset registration method is used with the Axcess System Kit.

## Indications for use
Intranasal or sinuses 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/K960330
Methodology: https://510kreport.com/methodology