# K993673: SNN Fluoro Navigation System

- Pathway: 510(k) (Traditional)
- Applicant: I.S.G. Technologies, Inc.
- Decided: Dec 21, 1999 after 50 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 K982570 (1999). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982570: SNN Scout, I.S.G. Technologies, Inc. (1999) Summary page 1.
- K990214: Fluoronav Module for the Stealthstation System, Surgical Navigation Technologies, Inc. (1999) Summary page 1.

## Indications for use
The SNN System is indicated for patients who have space-occupying lesions or malformations (both soft tissue and osseous) in the head. It is also indicated for patients who require decompressive or reconstructive surgery of the spine, or who have imaged space-occupying lesions or malformations of the spine. The SNN System is contraindicated for patients suspected of having Creutzfeld-Jacob’s disease if adequate sterilization of the instruments cannot be assured. The SNN Fluoro Navigation Module is also indicated for situations where reference to a rigid anatomical structure such as the skull, a long bone or vertebra can be identified relative to a fluoroscopic image of the anatomy.

Source page: https://510kreport.com/device/K993673
Methodology: https://510kreport.com/methodology