FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ONCENTRA MANUAL LOW DOSE RATE TREATMENT PLANNING
K Number: K113102
·
Decision Dec 12, 2011
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
255
Applicant Total
3
Review Days
54
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Basic Information
- Device Name
- ONCENTRA MANUAL LOW DOSE RATE TREATMENT PLANNING
- K Number
- K113102
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nucletron
- Date Received
- October 19, 2011
- Decision Date
- December 12, 2011
- Product Code
- MUJ
- 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 |
|---|---|---|---|
| MUJ | System, Planning, Radiation Therapy Treatment | FDA class 2 | Radiology |
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