# K981768: Stealthstation Treatment Guidance Platform

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Navigation Technologies, Inc.
- Decided: Nov 23, 1998 after 188 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
No predicates in its family tree.
279 later devices descend from it; 1 cites it directly.
2 of 280 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) StealthStation™ System: named in the summary without a submission number

## 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 appropriate, and where a reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a2 CT or MR based model of the anatomy. The StealthStation™ System is also indicated for intranasal or sinus use. The Ultrasonic Probe Option provides the user with supplemental real time imaging information to be used to monitor soft tissue locations relative to the CT or MR based model of the anatomy.

Source page: https://510kreport.com/device/K981768
Methodology: https://510kreport.com/methodology