# K990326: Optical Tracking System Microscope Module II, Model Ots Mmii

- Pathway: 510(k) (Special)
- Applicant: Radionics Software Applications, Inc.
- Decided: Mar 4, 1999 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: 1 generation back to K965139 (1997). 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)
- K981213: Universal Instrument Registration (Uir) Microscope Module I, Radionics, Inc. (1998) Summary page 1.
- K965139: Surgical Microscope Navigator (SMN) System/Surgical Tool Navigator (STN) System, Carl Zeiss, Inc. (1997) Summary page 1.

## Indications for use
Interactive, image-guided means of localizing targets in surgical procedures. OTS is indicated for use in cranial and spinal surgical procedures in which anatomical landmarks are not clearly visible or where a desired target is close to critical structures.

Source page: https://510kreport.com/device/K990326
Methodology: https://510kreport.com/methodology