# K964801: Optical Tracking System (Ots)

- Pathway: 510(k) (Traditional)
- Applicant: Radionics Software Applications, Inc.
- Decided: Jun 2, 1997 after 185 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: 2 generations back to K911783 (1994). 4 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951262: Operating Arm System (Oas), Radionics Software Applications, Inc. (1995) Summary page 1.
- K961844: Operating Arm System (Oas) [with CT and MR Images], Radionics Software Applications, Inc. (1996) Summary page 1.
- K954276: Stealthstation, Surgical Navigation Technologies, Inc. (1996) Summary page 1.

## Most influential descendants
- K974602: Optical Tracking System (Ots) (1998), 2 descendants of its own
- K990632: Optical Tracking System (Ots) (1999), 0 descendants of its own
- K983669: Optical Tracking System with Surface Matching Module, Model Ots (1998), 0 descendants of its own

## Indications for use
The Optical Tracking System (OTS) is a graphical planning tool that allows for pre-operative and operative planning of surgical procedures. The OTS is indicated for use in surgical procedures in which anatomical landmarks are noi clearly visible or where a desired target is close to critical structures.

Source page: https://510kreport.com/device/K964801
Methodology: https://510kreport.com/methodology