Vol. Hyperthermia Treatment System Model Vh8500
FDA PMAClass III (US FDA PMA)
by Cook, Inc.
Identity
- Trade Name
- VH8500 HYPERTHERMIA TREATMENT SYSTEM FDA PMA
- Generic Name
- Applicator, hyperthermia, interstitial FDA PMA
Identifiers
- PMA Number
- P880078 FDA PMA
- FDA Product Code
- LMZ FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Radiology FDA PMA
- FDA Decision
- APWD FDA PMA
The Volumetric Hyperthermia Treatment System Model VH8500 is an interstitial hyperthermia applicator designed to deliver localized heat therapy to targeted tissue volumes. It operates by generating controlled thermal energy to raise tissue temperature, aiding in the treatment of certain cancers and other conditions through thermal ablation or enhanced chemotherapeutic effects.
This system is supplied as a reusable medical device and is intended for use in radiology settings under professional supervision. It requires proper calibration and maintenance to ensure accurate temperature control and safety. The device is classified as Class III under FDA regulations and is authorized under PMA number P880078, with product code LMZ. Sterility and MRI safety considerations must be evaluated per clinical protocol.
Frequently asked questions
What is the primary purpose of the Volumetric Hyperthermia Treatment System Model VH8500, and how does it work?
The VH8500 is designed to deliver **localized heat therapy** to specific tissue volumes, primarily to aid in cancer treatment or enhance chemotherapeutic effects. It achieves this by generating controlled thermal energy to raise tissue temperature, effectively targeting tumors or affected areas through **interstitial hyperthermia**. This method is used under professional supervision in radiology settings to improve treatment outcomes by combining heat with other therapies.
Is the VH8500 a single-use or reusable device, and what maintenance does it require?
The VH8500 is a **reusable medical device**, meaning it is intended for repeated use in clinical settings. Since it operates with precise temperature control, it requires **proper calibration and maintenance** to ensure safety and accuracy. Regular upkeep, as outlined in the manufacturer’s guidelines, is essential to sustain performance and compliance with regulatory standards.
How is the device supplied, and what considerations should be made regarding sterility and MRI safety?
The VH8500 is supplied as a reusable system, meaning it is not pre-sterilized for single-use. **Sterility must be managed per clinical protocol** before each procedure to prevent contamination. Additionally, since it operates in radiology settings, **MRI safety must be carefully evaluated**—the device’s materials and design may interact with magnetic fields, so compatibility should be confirmed with the specific MRI system in use.
What regulatory pathway does the VH8500 follow, and what does this mean for clinicians or facilities?
The VH8500 is authorized under an **FDA Premarket Approval (PMA)** with PMA number **P880078**, classified as a **Class III device** due to its high-risk nature. This means the device has undergone rigorous review by the FDA to ensure safety and effectiveness for its intended use. Clinicians or facilities using it must adhere to the approved indications and follow the manufacturer’s instructions to maintain compliance with regulatory requirements.
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 | P880078 | Class III | Active |
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Manufacturer
- Manufacturer
- Cook, Inc.
Sources (1)
- FDA PMA P880078 24 fields · synced Sep 18, 2026