# K984245: Non-Invasive Dynamic Reference Frame (DRF) for Optical Tracking System, Model Ots

- Pathway: 510(k) (Special)
- Applicant: Radionics, Inc.
- Decided: Dec 18, 1998 after 21 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) Radionics Cranial DRF for OTS: named in the summary without a submission number
- (no number) Radionics Spinal DRF for OTS: named in the summary without a submission number

## 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. Examples of such procedures using OTS with the Non-Invasive DRF include, but are not limited to: Catheter shunt placement. Craniotomies / Tumor resections Skull lesioning Vascular malformations Various ENT procedures

Source page: https://510kreport.com/device/K984245
Methodology: https://510kreport.com/methodology