Identity
- Trade Name
- HYPERTHERMIA SYSTEM 100 A FDA PMA
- Generic Name
- Applicator, hyperthermia, superficial, rf/microwave FDA PMA
Identifiers
- PMA Number
- P880064 FDA PMA
- FDA Product Code
- LNC FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Radiology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Hyperthermia System 100 A is a superficial hyperthermia applicator that utilizes radiofrequency and microwave energy. It is designed to deliver localized thermal therapy for clinical applications as specified by its regulatory classification.
This device is manufactured by Medifocus, Inc. and is authorized for use under FDA PMA P880064. It is categorized within the radiology specialty and is intended for professional medical settings in accordance with its approved regulatory filing.
Frequently asked questions
What type of device is the Hyperthermia System 100 A?
The Hyperthermia System 100 A is a superficial hyperthermia applicator that uses radiofrequency and microwave energy to deliver thermal treatment.
Who is the manufacturer of this system?
The device is manufactured by Medifocus, Inc., located in Columbia, Maryland.
Is the Hyperthermia System 100 A FDA authorized?
Yes, the device is authorized under FDA PMA number P880064, which was granted following the regulatory review process.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P880064 | Class III | Active |
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Manufacturer
- Manufacturer
- Medifocus, Inc.
Sources (1)
- FDA PMA P880064 24 fields · synced Sep 18, 2026