LHN — System, Radiation Therapy, Charged-Particle, Medical Class II
FDA Device Classification
Classification Details
- Product Code
- LHN
- Device Class
- Class II
- Regulation Number
- 892.5050
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K250986 | mevion medical systems | S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) | September 12, 2025 |
| K243900 | empnia | eMotus Respiratory Motion Management System | June 27, 2025 |
| K242418 | p-cure | P-Cure Proton Therapy System (PPTS) | May 12, 2025 |
| K232032 | hitachi, ltd. radiation oncology systems, kashiwanoha | PROBEAT-FR | January 12, 2024 |
| K231863 | varian medical systems | ProBeam 360° Proton Therapy System v2.0 (Multiroom) | October 6, 2023 |
| K221996 | p-cure | P-Cure Proton Beam Therapy System | March 20, 2023 |
| K220883 | hitachi, ltd. radiation oncology systems, kashiwanoha | Small Field Applicator | December 15, 2022 |
| K221791 | varian medical systems | ProBeam 360° Proton Therapy System | December 1, 2022 |
| K201798 | iba dosimetry | myQA iON | July 17, 2020 |
| K201042 | hitachi | PROBEAT-CR | July 13, 2020 |
| K200282 | orfit industries | Orfit Aerial Couchtop | April 8, 2020 |
| K191821 | iba dosimetry | Blue Phantom PT | January 23, 2020 |
| K191521 | protom international holding corporation | Radiance 330 Proton Beam Therapy System | September 27, 2019 |
| K191801 | hitachi | PROBEAT-CR | September 13, 2019 |
| K181498 | ehmetdx | X-ray Imaging System for the McLaren Proton Treatment System | December 10, 2018 |
| K181789 | medcom | VeriSuite | September 21, 2018 |
| K181676 | hitachi ltd. healthcare hitachi works | Mini Ridge Filter and auxiliary functions for PROBEAT-V | August 15, 2018 |
| K172848 | mevion medical systems | MEVION S250i Proton Beam Radiation Therapy Device | December 27, 2017 |
| K171049 | hitachi, ltd. healthcare | Real Time Image Gating System for Proton Beam Therapy Systems | December 26, 2017 |
| K163500 | ion beam applications | IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, | August 17, 2017 |