# K972441: Radiotherapeutics RF Generator. Model #RF-2000

- Pathway: 510(k) (Traditional)
- Applicant: Radiotherapeutics Corp.
- Decided: Sep 4, 1997 after 66 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The RadioTherapeutics Corp. RF Generator is a medium power electrosurgical generator intended for use with separately approved electrodes for the thermal coagulation of soft tissues.

Source page: https://510kreport.com/device/K972441
Methodology: https://510kreport.com/methodology