FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ProBeam 360 Proton Therapy System v3.0
K Number: K252815
·
Decision Apr 23, 2026
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
91
Applicant Total
170
Review Days
231
Basic Information
- Device Name
- ProBeam 360 Proton Therapy System v3.0
- K Number
- K252815
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Varian Medical Systems, Inc.
- Date Received
- September 4, 2025
- Decision Date
- April 23, 2026
- Product Code
- LHN
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LHN | System, Radiation Therapy, Charged-Particle, Medical | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LHN), ordered by most recent decision date.
PROBEAT-CR
FDA 510(k)
FDA Class 2
·Radiology
S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)
FDA 510(k)
FDA Class 2
·Radiology
S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)
FDA 510(k)
FDA Class 2
·Radiology
eMotus Respiratory Motion Management System
FDA 510(k)
FDA Class 2
·Radiology
P-Cure Proton Therapy System (PPTS)
FDA 510(k)
FDA Class 2
·Radiology
PROBEAT-FR
FDA 510(k)
FDA Class 2
·Radiology
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|---|---|---|---|
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| K242957 | Identify (4.0) | Feb 7, 2025 | Substantially Equivalent |
| K242608 | Embozene Color-Advanced Microspheres | Jan 17, 2025 | Substantially Equivalent |
| K241764 | Mould Probe MR Safe | Jan 10, 2025 | Substantially Equivalent |