LHN
- Product code
- LHN
- Device name
- System, Radiation Therapy, Charged-Particle, Medical
- Device class
- Class 2
- 21 CFR
- 21 CFR 892.5050
- Medical specialty
- Radiology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 8
- Summaries archived here
- 7 (direct download)
- 510(k) clearances (all years, FDA)
- 92 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (8)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260174 | 2026-06-11 | Hitachi High-Tech Corp. | PROBEAT-CR | |
| K252815 | 2026-04-23 | Varian Medical Systems, Inc. | ProBeam 360 Proton Therapy System v3.0 | |
| K253406 | 2026-03-25 | Mevion Medical Systems, Inc. | S250-FIT Proton Beam Radiation Therapy Device (S250-… | FDA |
| K250986 | 2025-09-12 | Mevion Medical Systems, Inc. | S250-FIT Proton Beam Radiation Therapy Device (S250-… | |
| K243900 | 2025-06-27 | Empnia, Inc. | eMotus Respiratory Motion Management System | |
| K242418 | 2025-05-12 | P-Cure, Ltd. | P-Cure Proton Therapy System (PPTS) | |
| K232032 | 2024-01-12 | Hitachi, Ltd. Radiation Oncology Syste… | PROBEAT-FR | |
| K231863 | 2023-10-06 | Varian Medical Systems, Inc. | ProBeam 360° Proton Therapy System v2.0 (Multiroom) |
Official FDA classification page: LHN
Classification and pathway per current FDA publications. Data from openFDA (CC0).