# K982364: Wireless Standard Probe, Dynamic Reference Frame (DRF)

- Pathway: 510(k) (Special)
- Applicant: Radionics, Inc.
- Decided: Aug 5, 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
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 Optical Tracking System (OTS): named in the summary without a submission number

## Indications for use
The Radionics Optical Tracking System (OTS) Wireless System 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/K982364
Methodology: https://510kreport.com/methodology