Isocentric Neutron Therapy Systems
510(k) K812337
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK812337 | Date2 Oct 1981 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- IWL
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.5300
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The Isocentric Neutron Therapy Systems is a Radiation Therapy, Neutron, Medical System designed to generate high-energy neutrons for targeted cancer treatment. These systems employ cyclotron-based neutron production to deliver precise radiation doses to malignant tissues, particularly effective for radioresistant tumors. The device integrates treatment planning software, patient positioning equipment, and real-time monitoring to ensure accurate delivery. Its isocentric design allows for multi-directional irradiation, optimizing coverage of complex tumor geometries.
These systems are supplied as traditional 510(k)-cleared medical devices under FDA regulation number 892.5300, classified as Class II. They are intended for use in radiation oncology facilities and require specialized infrastructure, including cyclotron operation and radiation safety protocols. While not explicitly stated as single-use or reusable, neutron therapy systems are typically non-disposable and require maintenance, calibration, and periodic regulatory inspections. No MRI compatibility or sterility specifications are provided in the available data.
Other devices from The Cyclotron Corp.
Questions
AI-generated answers, 20 Sep 2026
What types of cancer are these neutron therapy systems primarily designed to treat, and why are they considered effective for those cases?
These Isocentric Neutron Therapy Systems are specifically designed to target radioresistant tumors, which are cancers that do not respond well to conventional radiation therapy. Neutrons are particularly effective because they deposit more energy in dense tissues, such as those found in radioresistant tumors like sarcomas, melanomas, and some brain cancers. The high-energy neutrons generated by the cyclotron-based system allow for more precise and effective dose delivery to malignant tissues while sparing surrounding healthy tissue.
How is the device supplied, and what kind of infrastructure does a facility need to operate it?
The Isocentric Neutron Therapy Systems are supplied as fully integrated medical devices, including cyclotron-based neutron production, treatment planning software, patient positioning equipment, and real-time monitoring tools. To operate this system, a facility must have specialized infrastructure such as dedicated radiation oncology space, cyclotron operation capabilities, and robust radiation safety protocols. Additionally, trained personnel are required to manage the device’s complex operations, maintenance, and regulatory compliance.
Is this device single-use or reusable, and what maintenance or regulatory requirements apply?
The Isocentric Neutron Therapy Systems are not single-use devices; they are designed for repeated use within a radiation oncology facility. However, they require regular maintenance, calibration, and periodic regulatory inspections to ensure safe and accurate operation. Given their complexity and the high-energy neutron production involved, adherence to strict safety protocols and compliance with radiation therapy standards are essential.
What regulatory pathway was followed for FDA clearance, and how does this classification impact its use?
The Isocentric Neutron Therapy Systems were cleared through a traditional 510(k) process under FDA regulation number 892.5300, with a decision classification of