FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
PROBEAT-CR
K Number: K260174
·
Decision Jun 11, 2026
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
91
Applicant Total
1
Review Days
141
Basic Information
- Device Name
- PROBEAT-CR
- K Number
- K260174
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hitachi High-Tech Corp.
- Date Received
- January 21, 2026
- Decision Date
- June 11, 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.
ProBeam 360 Proton Therapy System v3.0
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