ProBeam 360 Proton Therapy System v3.0
FDA 510(k) K252815 · Varian Medical Systems, Inc.
510(k) numberK252815
Submission
- Device name
- ProBeam 360 Proton Therapy System v3.0
- Applicant
- Varian Medical Systems, Inc.
Palo Alto, CA, US - Received
- September 4, 2025
- Decision date
- April 23, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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|---|---|---|---|
| K260174 | Probeat-CrLHN · Traditional | Hitachi High-Tech Corp. | 06/11/2026SE |
| K253406 | S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)LHN · Traditional | Mevion Medical Systems, Inc. | 03/25/2026SE |
| K250986 | S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)LHN · Traditional | Mevion Medical Systems, Inc. | 09/12/2025SE |
| K243900 | eMotus Respiratory Motion Management SystemLHN · Traditional | Empnia, Inc. | 06/27/2025SE |
| K242418 | P-Cure Proton Therapy System (PPTS)LHN · Traditional | P-Cure, Ltd. | 05/12/2025SE |
| K232032 | Probeat-FrLHN · Traditional | Hitachi, Ltd. Radiation Oncology Systems… | 01/12/2024SE |
| K231863 | ProBeam 360° Proton Therapy System v2.0 (Multiroom)LHN · Traditional | Varian Medical Systems, Inc. | 10/06/2023SE |
| K221996 | P-Cure Proton Beam Therapy SystemLHN · Traditional | P-Cure, Ltd. | 03/20/2023SE |
| K220883 | Small Field ApplicatorLHN · Traditional | Hitachi, Ltd. Radiation Oncology Systems… | 12/15/2022SE |
| K221791 | ProBeam 360° Proton Therapy SystemLHN · Traditional | Varian Medical Systems, Inc. | 12/01/2022SE |
More from Varian Medical Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K261856 | Halcyon, Ethos Radiotherapy System (5.0)IYE · Traditional | 08/03/2026SE |
| K261306 | AI Contouring (VA10A)QKB · Traditional | 07/10/2026SE |
| K260750 | Virtual Cone (1.0)MUJ · Traditional | 07/08/2026SE |
| K253026 | Respiratory Gating for Scanners (2.1)JAK · Traditional | 06/04/2026SE |
| K252717 | MAASTRO Rectal Applicator SetJAQ · Traditional | 05/20/2026SE |
| K252304 | syngo.via RT Image Suite VC10MUJ · Traditional | 03/18/2026SE |
| K252977 | Halcyon, Ethos Radiotherapy System (5.0)IYE · Traditional | 01/21/2026SE |
| K252919 | Identify (5.0)IYE · Traditional | 12/16/2025SE |
| K252884 | Guided Aarhus Applicator SetJAQ · Traditional | 11/19/2025SE |
| K252948 | TrueBeam, TrueBeam STX, Edge and VitalBeamIYE · Traditional | 10/07/2025SE |
Questions and answers
When was ProBeam 360 Proton Therapy System v3.0 cleared by the FDA?
ProBeam 360 Proton Therapy System v3.0 (K252815) received a 510(k) decision of Substantially Equivalent on April 23, 2026, 231 days after the submission was received.
What is the product code of K252815?
The FDA product code is LHN – System, Radiation Therapy, Charged-Particle, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.