# K042096: Misonix Inc. Sonatherm 600 Ultrasonic Lesion Generating System

- Pathway: 510(k) (Traditional)
- Applicant: Misonix, Inc.
- Decided: Jan 26, 2006 after 540 days
- Product code: NTB (System, Ablation, Ultrasound And 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
Longest line of descent: 1 generation back to K901540 (1991). 5 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983214: Rita RF Generator and Accessories, Model 500 Series, Rita Medical Systems (2000) Summary page 1.
- K993944: Rita Model 1500 Electrosurgical Generator, Power Cord,Footswitch,Main Cable, Dispersive Electrode, Rita Medical Systems (1999) Summary page 1.
- K003978: Afx Microwave Generator, Flex Ablation Wand, Lynx Ablation Wand, Model Series 1000, P/N 102006, P/N 102007, Afx, Inc. (2001) Summary page 1.
- K011074: Cryocare Surgical System, Endocare, Inc. (2002) Summary page 1.
- K901540: Model RFG-3C Radiofrequency Lesion Generator, Radionics, Inc. (1991) Summary page 1.

## Most influential descendants
- 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

## Indications for use
The Sonatherm is indicated For the laparoseopic or intraopenrtive ablation of soil tissue from the ultrasound tbcal zone back to the surtice ofethe targeted treatment area in General SUrgery.

Source page: https://510kreport.com/device/K042096
Methodology: https://510kreport.com/methodology