Model note · Hyperthermia System
Pyrexar BSD-2000 Hyperthermia System
The BSD-2000 is a deep regional hyperthermia system that heats deep-seated solid tumours with radiofrequency energy from a ring of antennas surrounding the patient. In the US it is approved under a Humanitarian Device Exemption alongside radiotherapy for cervical cancer patients who cannot have chemotherapy, and it has been sold internationally since 1988. Its key engineering idea is phased-array focusing: frequency, phase and amplitude across several channels are adjusted to steer the heating to the tumour.
The model
Maker, model and type.
- Maker
- Pyrexar Medical, Inc. (formerly BSD Medical Corporation)
- Model
- BSD-2000 Hyperthermia System (BSD-2000B and BSD-2000U)
- Device type
- Hyperthermia System
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| RF frequency range | 75 to 120 MHz | Source |
| Maximum output power | 1300 W (BSD-2000B basic) or 1800 W (BSD-2000U upgraded) | Source |
| Subsystems | RF power generator, thermistor-based thermometry, computerised monitoring and control, applicator with patient support | Source |
| Applicator | Deep-heating Sigma Base with antenna array applicators | Source |
| QA accessory | Tissue-equivalent lamp phantom to verify energy focus, steering and operation | Source |
| Site requirement | RF-shielded treatment room (not supplied with the system) for FCC compliance | Source |
| Maximum patient body width | 49 cm left to right (wider is a contraindication) | Source |
| FDA status | HDE H090002, approved 18 November 2011; HUD designation 09-0214 | Source |
Recalls
Recalls.
This note lists no recalls. Check the FDA recall database for the latest record.
Safety
Safety warnings from the record.
- Contraindicated with pacemakers, defibrillators, pumps, neurostimulators, cochlear implants or any implanted or worn active electronic device. Source
- Contraindicated with conductive, metal or foreign objects in, on or attached to the body. Source
- Patients who cannot feel or report pain properly, such as those with significant neuropathy, must not be treated. Source
- Recognised adverse effects include burns, blistering, ulceration, fat or muscle necrosis and thermal stress. Source
- Use is restricted to qualified operators supervised by a physician experienced in clinical hyperthermia. Source
Sources
Where this note comes from.
- FDA Summary of Safety and Probable Benefit, HDE H090002, BSD-2000
- FDA HDE database record H090002
- openFDA recall search, BSD-2000 (no matches)
- openFDA MAUDE search, BSD-2000 (no matches)
Not covered: The Pyrexar website blocked automated access and no public operator or service manual was found, so error codes, the number of RF channels and antennas, and applicator details are missing. There are no FDA recalls and no MAUDE reports under this brand, so no failing parts could be sourced.
BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.
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