# K990632: Optical Tracking System (Ots)

- Pathway: 510(k) (Traditional)
- Applicant: Radionics, Inc.
- Decided: Apr 29, 1999 after 62 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). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964801: Optical Tracking System (Ots), Radionics Software Applications, Inc. (1997) Summary page 1.
- K974602: Optical Tracking System (Ots), Radionics Software Applications, Inc. (1998) Summary page 1.
- K954276: Stealthstation, Surgical Navigation Technologies, Inc. (1996) Summary page 1.
- K971247: SNT Disposable Biopsy Needle, Surgical Navigation Technologies, Inc. (1997) Summary page 1.

## Indications for use
The OTS is a graphical planning tool that allows for preoperative planning of, and intraoperative navigation during, cranial and spinal surgical procedures. This includes use in frameless cranial biopsy procedures.

Source page: https://510kreport.com/device/K990632
Methodology: https://510kreport.com/methodology