FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SUMITOMO PROTON THERAPY SYSTEM
K Number: K130426
·
Decision Nov 19, 2013
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
91
Applicant Total
2
Review Days
272
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Basic Information
- Device Name
- SUMITOMO PROTON THERAPY SYSTEM
- K Number
- K130426
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sumitomo Heavy Industries, Ltd.
- Date Received
- February 20, 2013
- Decision Date
- November 19, 2013
- 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 |
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Other Clearances by Sumitomo Heavy Industries, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K160612 | Sumitomo Proton Therapy System | Aug 17, 2016 | Substantially Equivalent |