# K981686: Stealthstation System Digitizer Change

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Navigation Technologies, Inc.
- Decided: Aug 7, 1998 after 86 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K954276 (1996). 1 ancestor in all.
281 later devices descend from it; 2 cite it directly.
2 of 283 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954276: Stealthstation, Surgical Navigation Technologies, Inc. (1996) 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

## Indications for use
The StealthStation® System is intended as an aid for precisely locating anatomical locations in either open or percutaneous procedures. The StealthStation® System is indicated for any medical condition in which the use of stereotactic surgery may be considered to be safe and effective, and where a reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT or MR based model of the anatomy.

Source page: https://510kreport.com/device/K981686
Methodology: https://510kreport.com/methodology