# K954276: Stealthstation

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Navigation Technologies, Inc.
- Decided: Jan 24, 1996 after 133 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
549 later devices descend from it; 23 cite it directly.
7 of 550 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## 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
- K981686: Stealthstation System Digitizer Change (1998), 281 descendants of its own
- K040050: Instatrak System with Multiple Dataset Navigation, Model IT3500 (2004), 280 descendants of its own
- K992461: Stealthstation Treatment Guidance Platform (2000), 279 descendants of its own

## Recalls of this device
- Jan 28, 2005 · Not classified · Z-0711-05: The Stealth Station Cranial Application Version 4.5 contains a software anomaly, which may present a hazard to the patient.

Source page: https://510kreport.com/device/K954276
Methodology: https://510kreport.com/methodology