FDA 510(k)
FDA class 2
Substantially Equivalent
🇧🇪 Belgium
Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2)
K Number: K152224
·
Decision Aug 9, 2016
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
91
Applicant Total
1
Review Days
368
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Basic Information
- Device Name
- Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2)
- K Number
- K152224
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ion Beam Application S.A.
- Date Received
- August 7, 2015
- Decision Date
- August 9, 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 |
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