# K983669: Optical Tracking System with Surface Matching Module, Model Ots

- Pathway: 510(k) (Special)
- Applicant: Radionics, Inc.
- Decided: Nov 18, 1998 after 30 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: 4 generations back to K911783 (1994). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974602: Optical Tracking System (Ots), Radionics Software Applications, Inc. (1998) Summary page 1.
- K954276: Stealthstation, Surgical Navigation Technologies, Inc. (1996) Summary page 1.

## Indications for use
The Optical Tracking System (OTS) is a graphical planning tool that allows for pre-operative and operative planning of cranial and spinal surgical procedures. The OTS is indicated for use in cranial and spinal surgical procedures in which anatomical structures are not clearly visible or where a desired target is close to critical regions.

Source page: https://510kreport.com/device/K983669
Methodology: https://510kreport.com/methodology