FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory
K Number: K161163
·
Decision Jul 13, 2016
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
91
Applicant Total
8
Review Days
79
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Basic Information
- Device Name
- PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory
- K Number
- K161163
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hitachi , Ltd.
- Date Received
- April 25, 2016
- Decision Date
- July 13, 2016
- 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
ProBeam 360 Proton Therapy System v3.0
FDA 510(k)
FDA Class 2
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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
Other Clearances by Hitachi , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K201042 | PROBEAT-CR | Jul 13, 2020 | Substantially Equivalent |
| K191801 | PROBEAT-CR | Sep 13, 2019 | Substantially Equivalent |
| K172087 | SANGRAY | Oct 27, 2017 | Substantially Equivalent |
| K163505 | ARIETTA PRECISION | May 30, 2017 | Substantially Equivalent |
| K162902 | ARIETTA Prologue Diagnostic Ultrasound system and Transducers | Dec 15, 2016 | Substantially Equivalent |
| K162583 | ALOKA LISENDO 880 | Nov 17, 2016 | Substantially Equivalent |
| K060834 | PROBEAT WITH MGCS | Apr 19, 2006 | Substantially Equivalent |