510(k) · Cleared

Cleared

TheraVision Ultrasound Ablation System and ACOUSTx Applicators

K150019510(k) TraditionalCleared Jan 13, 2016373-day reviewClass II21 CFR 878.4400

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Acoustic Medsystems, Inc. · NTB System, Ablation, Ultrasound And Accessories

Cleared on Jan 13, 2016 as substantially equivalent to K070779 (Misonix, Inc., 2008) and 4 other predicates after a 373-day review. Its family tree reaches back 7 generations to 1993.

Decided: Jan 13, 2016
Review: 373 days
Class: Class II
Product code: NTB
Recalls: None
Predicates: 5

Its longest line of descent runs back 7 generations to K926514 (1993). 49 ancestors in all, the oldest K790187 (1979). No later device cites it as a predicate yet.

By dateBy generation

Root · 7 generations backK926514 Endoscopic Ultrasound System Type 20Olympus Corp. · 1993 · Recalled
6 generations backK963023 Ultrasound Gastroscope GF Type UM30POlympus America, Inc. · 1997
5 generations backK994373 Hdi 1500/SA 8800 Ultrasound System with Multiplane Transesophageal…Atl Ultrasound, Inc. · 2000
4 generations backK030191 Terason Model 2000/Bas Portable Ultrasound SystemTeratech Corp. · 2003
3 generations backK032333 Cryocare CS Surgical SystemEndocare, Inc. · 2003
2 generations backK050347 Modification to Cryocare CS Surgical SystemEndocare, Inc. · 2005
1 generation backK070779 Sonatherm 600I Ultrasonic Lesion Generating SystemMisonix, Inc. · 2008
This deviceK150019 TheraVision Ultrasound Ablation System and ACOUSTx ApplicatorsAcoustic Medsystems, Inc. · 2016

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−7	K926514	Endoscopic Ultrasound System Type 20	Olympus Corp.	1993	1
−6	K963023	Ultrasound Gastroscope GF Type UM30P	Olympus America, Inc.	1997	—
−5	K994373	Hdi 1500/SA 8800 Ultrasound System with Multiplane Transesophageal Ultrasound…	Atl Ultrasound, Inc.	2000	—
−4	K030191	Terason Model 2000/Bas Portable Ultrasound System	Teratech Corp.	2003	—
−3	K032333	Cryocare CS Surgical System	Endocare, Inc.	2003	—
−2	K050347	Modification to Cryocare CS Surgical System	Endocare, Inc.	2005	—
−1	K070779	Sonatherm 600I Ultrasonic Lesion Generating System	Misonix, Inc.	2008	—
0 (this device)	K150019	TheraVision Ultrasound Ablation System and ACOUSTx Applicators	Acoustic Medsystems, Inc.	2016	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1979	1	0
1985	1	0
1986	3	0
1987	1	0
1991	1	0
1994	1	0
1996	3	0
1997	2	0
1998	3	0
1999	5	0
2000	3	0
2001	4	0
2002	4	0
2003	5	0
2004	2	0
2006	2	0
2008	1	0

FIG. 1 — Lineage of K150019, 1993–2016Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in NTB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

What was it cleared against? (5)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K070779	Sonatherm 600I Ultrasonic Lesion Generating System Summary page 4 …System and ACOUSTx Applicators are substantially equivalent to the following legally marketed devices:  Sonatherm 600i Ultrasonic Lesion Generating System [K070779] - Primary Predicate  Cool-tipTM RF Ablation System [K053290]  Valleylab Microwave Ablation Generator and Micro…	Misonix, Inc.	2008	—
*	K053290	Cool-Tip RF Generator, Cool-Tip RF System Accessories Summary page 4 …following legally marketed devices:  Sonatherm 600i Ultrasonic Lesion Generating System [K070779] - Primary Predicate  Cool-tipTM RF Ablation System [K053290]  Valleylab Microwave Ablation Generator and Microwave Antennas [K072687 and K011676/K032702, respectively]…	Valleylab	2006	—
*	K072687	Valleylab Microwave Ablation Generator Summary page 4 …enerating System [K070779] - Primary Predicate  Cool-tipTM RF Ablation System [K053290]  Valleylab Microwave Ablation Generator and Microwave Antennas [K072687 and K011676/K032702, respectively] 510(k) Notification: TheraVision System and ACOUSTx Applicators…	Covidien Lp, Formerly Know AS Valleylab, A Divison	2008	—
*	K011676	Vivawave Microwave System Summary page 4 …779] - Primary Predicate  Cool-tipTM RF Ablation System [K053290]  Valleylab Microwave Ablation Generator and Microwave Antennas [K072687 and K011676/K032702, respectively] 510(k) Notification: TheraVision System and ACOUSTx Applicators…	Vivant Medical, Inc.	2002	1
*	K032702	Vivatip Microwave Ablation Probe Summary page 4 …rimary Predicate  Cool-tipTM RF Ablation System [K053290]  Valleylab Microwave Ablation Generator and Microwave Antennas [K072687 and K011676/K032702, respectively] 510(k) Notification: TheraVision System and ACOUSTx Applicators…	Vivant Medical, Inc.	2003	—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 23 years and passes through 7 companies; a new generation was cleared every 3.1 years on median.
9 of the 49 ancestors have a recall of any class.

How does its category compare?

All NTB devices

NTB System, Ablation, Ultrasound And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.

FDA decisions per year · NTB

1in 2016

2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NTB

Too few NTB 510(k)s in any year since 2007 to give a median.

Recalls per year · NTB

No recall names NTB since 2007.

Adverse event reports per year · NTB

2in 2012

2007high 19 (2009) · low 0 (2011)2025

MAUDE reports naming product code NTB, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	2
2008	1	—	5
2009	0	—	19
2010	0	—	5
2011	0	—	0
2012	0	—	2
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	1	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K150019 · printed Nov 4, 2026

Cite this page

510(k) Report. “K150019: TheraVision Ultrasound Ablation System and ACOUSTx Applicators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K150019

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026