Sonotherm 1000 Ultrasound Hyperthermia System
by Labthermics Technologies, Inc.
PMA P880062
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP880062 | Date29 Sep 1989 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Generic Name
- Applicator, hyperthermia, deep heating, ultrasound
- PMA Number
- FDA Product Code
- LNB
- Device Class
- Class III
- Advisory Committee
- Radiology
- FDA Decision
- APPR Approved
Overview
AI-generated summary, 18 Sep 2026
The Sonotherm 1000 Ultrasound Hyperthermia System is a medical device categorized as an applicator for deep heating via ultrasound. It is designed to deliver targeted thermal energy to tissues as part of hyperthermia therapy procedures.
This system is manufactured by Labthermics Technologies, Inc., based in Champaign, Illinois. The device is authorized for use under FDA PMA number P880062, following a decision date of September 29, 1989.
Questions
AI-generated answers, 18 Sep 2026
What is the primary function of the Sonotherm 1000?
The Sonotherm 1000 functions as an applicator for deep heating, utilizing ultrasound technology to provide hyperthermia treatment.
Who is the manufacturer of this hyperthermia system?
The Sonotherm 1000 is manufactured by Labthermics Technologies, Inc., which is located in Champaign, Illinois.
Is the Sonotherm 1000 authorized for medical use?
Yes, the device is authorized under FDA PMA number P880062, which was granted following a regulatory review process concluded in 1989.