LHN · System, Radiation Therapy, Charged-Particle, Medical
Radiology · 21 CFR 892.5050 · Class 2
Overview
| Product Code | LHN |
|---|---|
| Device Name | System, Radiation Therapy, Charged-Particle, Medical |
| Regulation | 21 CFR 892.5050 |
| Device Class | Class 2 |
| Review Panel | Radiology |
Identification
A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.
Classification Rationale
Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Recent Cleared Devices (20 of 91)
Showing 20 most recent of 91 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252815 | ProBeam 360 Proton Therapy System v3.0 | Varian Medical Systems, Inc. | Apr 23, 2026 | SESE |
| K253406 | S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) | Mevion Medical Systems, Inc. | Mar 25, 2026 | SESE |
| K250986 | S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) | Mevion Medical Systems, Inc. | Sep 12, 2025 | SESE |
| K243900 | eMotus Respiratory Motion Management System | Empnia, Inc. | Jun 27, 2025 | SESE |
| K242418 | P-Cure Proton Therapy System (PPTS) | P-Cure, Ltd. | May 12, 2025 | SESE |
| K232032 | PROBEAT-FR | Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha | Jan 12, 2024 | SESE |
| K231863 | ProBeam 360° Proton Therapy System v2.0 (Multiroom) | Varian Medical Systems, Inc. | Oct 6, 2023 | SESE |
| K221996 | P-Cure Proton Beam Therapy System | P-Cure, Ltd. | Mar 20, 2023 | SESE |
| K220883 | Small Field Applicator | Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha | Dec 15, 2022 | SESE |
| K221791 | ProBeam 360° Proton Therapy System | Varian Medical Systems, Inc. | Dec 1, 2022 | SESE |
| K201798 | myQA iON | Iba Dosimetry GmbH | Jul 17, 2020 | SESE |
| K201042 | PROBEAT-CR | Hitachi , Ltd. | Jul 13, 2020 | SESE |
| K200282 | Orfit Aerial Couchtop | Orfit Industries NV | Apr 8, 2020 | SESE |
| K191821 | Blue Phantom PT | Iba Dosimetry GmbH | Jan 23, 2020 | SESE |
| K191521 | Radiance 330 Proton Beam Therapy System | Protom International Holding Corporation | Sep 27, 2019 | SESE |
| K191801 | PROBEAT-CR | Hitachi , Ltd. | Sep 13, 2019 | SESE |
| K181498 | X-ray Imaging System for the McLaren Proton Treatment System | Ehmetdx, LLC | Dec 10, 2018 | SESE |
| K181789 | VeriSuite | Medcom GmbH | Sep 21, 2018 | SESE |
| K181676 | Mini Ridge Filter and auxiliary functions for PROBEAT-V | Hitachi Ltd. Healthcare Hitachi Works | Aug 15, 2018 | SESE |
| K172848 | MEVION S250i Proton Beam Radiation Therapy Device | Mevion Medical Systems | Dec 27, 2017 | SESE |
Top Applicants
- Ion Beam Applications S.A. — 13 clearances
- Varian Medical Systems, Inc. — 5 clearances
- Hitachi , Ltd. — 4 clearances
- Hitachi, Ltd., Health Care Company — 4 clearances
- Anzai Medical Co., Ltd. — 3 clearances
