# K040050: Instatrak System with Multiple Dataset Navigation, Model IT3500

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems Navigation and Visualization IN
- Decided: Mar 24, 2004 after 72 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 K983410 (1999). 6 ancestors in all.
280 later devices descend from it; 3 cite it directly.
3 of 287 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020631: IPLAN, Brainlab AG (2002) Summary page 3.
- K954276: Stealthstation, Surgical Navigation Technologies, Inc. (1996) Summary page 3.

## 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
- Feb 24, 2011 · Not classified · Z-1941-2011: Sensor cables may suffer material degradation when exposed to certain sterilization procedures.
- Feb 24, 2011 · Not classified · Z-1942-2011: Sensor cables may suffer material degradation when exposed to certain sterilization procedures.
- Sep 15, 2006 · Class I · Z-1985-2012: Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. On October 11, 2006, GE Healthcare recall
- Dec 13, 2004 · Not classified · Z-0691-05: Enhanced sterility testing revealed the sterilization efficacy of accessories ('Sensors') used with certain Navigation and Visualization systems may be compromised.
- Sep 15, 2004 · Not classified · Z-0155-05: Threads on this accessory spine clamp may become tight, which may make it difficult to install or remove.
- 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 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 anatomical structures such as sinus, skull, long bone, or vertebra, visible on medical images such as CT, MR, or X-ray.

Source page: https://510kreport.com/device/K040050
Methodology: https://510kreport.com/methodology