# K901540: Model RFG-3C Radiofrequency Lesion Generator

- Pathway: 510(k) (Traditional)
- Applicant: Radionics, Inc.
- Decided: Apr 8, 1991 after 371 days
- Product code: GXD (Generator, Lesion, Radiofrequency)
- Device class: 2
- Regulation: 21 CFR 882.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K042096: Misonix Inc. Sonatherm 600 Ultrasonic Lesion Generating System (2006), 2 descendants of its own
- K070779: Sonatherm 600I Ultrasonic Lesion Generating System (2008), 1 descendant of its own
- K150019: TheraVision Ultrasound Ablation System and ACOUSTx Applicators (2016), 0 descendants of its own

Source page: https://510kreport.com/device/K901540
Methodology: https://510kreport.com/methodology