FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MUCHECK V7.0
K Number: K061152
·
Decision May 10, 2006
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
91
Applicant Total
4
Review Days
14
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Basic Information
- Device Name
- MUCHECK V7.0
- K Number
- K061152
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Oncology Data Systems, Inc.
- Date Received
- April 26, 2006
- Decision Date
- May 10, 2006
- Product Code
- LHN
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- Y
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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