Photoelectron Corporation
United StatesFDA applicant, unverified
- Devices
- 2
What Photoelectron Corporation makes
Photoelectron Corporation manufactures the Photon Radiosurgery System (PRS), a device designed for precise, non-invasive radiation therapy targeting tumors and other abnormalities in the brain and body. The system delivers high-dose radiation with sub-millimeter accuracy, enabling complex treatment plans for conditions such as brain tumors, arteriovenous malformations, and trigeminal neuralgia. It operates using photon beams generated through advanced linear accelerator technology, tailored for radiosurgery applications. The device is intended for use in specialized medical facilities with experienced radiation oncology teams.
The Photon Radiosurgery System (PRS) is classified as a Class II medical device under FDA regulations, requiring premarket notification (510(k)) clearance before commercial distribution in the United States. The system is listed in the FDA’s 510(k) database, reflecting its regulatory status for radiosurgery applications. The company is headquartered in the United States, where its devices are authorized for use.
Catalogue
Photon Radiosurgery System (Prs) Ref K992577
Regimes: 510(k) Registry: 510(k)Photon Radiosurgery System (Prs) Ref K964947
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Photoelectron Corporation have in the registry?
The registry currently lists 2 devices for Photoelectron Corporation. Devices recorded under merged duplicate company entries are counted once.
Which registries list Photoelectron Corporation's devices?
Among its 2 most recently registered devices, Photoelectron Corporation has devices listed in FDA 510(k) (2 devices).
What risk classes do Photoelectron Corporation's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Photoelectron Corporation's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Photoelectron Corporation in the registry?
The most recently registered devices listed for Photoelectron Corporation include PHOTON RADIOSURGERY SYSTEM (PRS).