Clini-Therm Mark I/IV
PMA P840015
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP840015 | Date16 Aug 1985 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Generic Name
- System, rf/microwave hyperthermia, cancer treatment
- PMA Number
- FDA Product Code
- LOC
- Device Class
- Class III
- Advisory Committee
- Radiology
- FDA Decision
- APPR Approved
Overview
AI-generated summary, 18 Sep 2026
The Clini-Therm Mark I/IV is a radiofrequency and microwave hyperthermia system intended for use in cancer treatment. This medical device utilizes electromagnetic energy to induce localized heating within targeted tissue as part of a therapeutic regimen.
This system is manufactured by Clini-Therm Corp. and is authorized for use under FDA PMA number P840015. It is categorized within the radiology specialty and is subject to the regulatory requirements associated with class 3 medical devices.
Other devices from Clini-Therm Corp.
Questions
AI-generated answers, 18 Sep 2026
What is the primary function of the Clini-Therm Mark I/IV?
The Clini-Therm Mark I/IV is a specialized system designed to deliver radiofrequency and microwave hyperthermia for the purpose of cancer treatment.
Is the Clini-Therm Mark I/IV FDA authorized?
Yes, the device is authorized under the FDA Premarket Approval (PMA) process, specifically identified by PMA number P840015.
What medical specialty is this device associated with?
The Clini-Therm Mark I/IV is classified under the radiology advisory committee, which oversees systems used for diagnostic and therapeutic imaging and energy-based treatments.