LHN — System, Radiation Therapy, Charged-Particle, Medical Class II
FDA product code LHN covers "System, Radiation Therapy, Charged-Particle, Medical", a Class II medical device regulated under 21 CFR 892.5050. Submissions are reviewed by the Radiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K260174 | hitachi high-tech | PROBEAT-CR | June 11, 2026 |
| K252815 | varian medical systems | ProBeam 360 Proton Therapy System v3.0 | April 23, 2026 |
| K253406 | mevion medical systems | S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) | March 25, 2026 |
| 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 |