# K150019: TheraVision Ultrasound Ablation System and ACOUSTx Applicators

- Pathway: 510(k) (Traditional)
- Applicant: Acoustic Medsystems, Inc.
- Decided: Jan 13, 2016 after 373 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: 7 generations back to K926514 (1993). 49 ancestors in all.
No later device cites it as a predicate yet.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070779: Sonatherm 600I Ultrasonic Lesion Generating System, Misonix, Inc. (2008) Summary page 4.
- K053290: Cool-Tip RF Generator, Cool-Tip RF System Accessories, Valleylab (2006) Summary page 4.
- K072687: Valleylab Microwave Ablation Generator, Covidien Lp, Formerly Know AS Valleylab, A Divison (2008) Summary page 4.
- K011676: Vivawave Microwave System, Vivant Medical, Inc. (2002) Summary page 4.
- K032702: Vivatip Microwave Ablation Probe, Vivant Medical, Inc. (2003) Summary page 4.

## Indications for use
The TheraVision Ultrasound Ablation System, ACOUSTx Applicators, and accessories are intended for the laparoscopic, intraoperative, and percutaneous coagulation and ablation of soft tissue. It is not indicated for ablation of prostate tissue.

Source page: https://510kreport.com/device/K150019
Methodology: https://510kreport.com/methodology