# K994421: SNN Stereotaxic Planning Application; SNN Stereotactic Application

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Navigation Specialists, Inc.
- Decided: Feb 23, 2000 after 56 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.
No later device cites it as a predicate yet.
0 of 1 device 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) StereoPlan software from Radionics: named in the summary without a submission number
- (no number) AtlasPlan software from Radionics: named in the summary without a submission number
- (no number) @Target software from Brainlab: named in the summary without a submission number

## Indications for use
The SNN Stereotactic Planning Application module is intended to be used as an accessory for planning stereotactic frame-based procedures such as biopsies, functional stereotaxy, tumor resections, vascular malformation surgeries, thalamotomies and pallidotomies.

Source page: https://510kreport.com/device/K994421
Methodology: https://510kreport.com/methodology