FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
FRAXION
K Number: K112210
·
Decision Nov 22, 2011
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
733
Applicant Total
8
Review Days
113
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Basic Information
- Device Name
- FRAXION
- K Number
- K112210
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medical Intelligence Medizintechnik GmbH
- Date Received
- August 1, 2011
- Decision Date
- November 22, 2011
- Product Code
- IYE
- 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 |
|---|---|---|---|
| IYE | Accelerator, Linear, Medical | FDA class 2 | Radiology |
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| K071870 | HEXAPOD RT COUCH TOP | Jul 8, 2007 | Substantially Equivalent |
| K041448 | HEXAPOD RT COUCHTOP | Jun 16, 2004 | Substantially Equivalent |
| K030439 | HEADFIX | May 8, 2003 | Substantially Equivalent |
| K013391 | BODYFIX | Jan 11, 2002 | Substantially Equivalent |