FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
BODYFIX
K Number: K013391
·
Decision Jan 11, 2002
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
733
Applicant Total
8
Review Days
88
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Basic Information
- Device Name
- BODYFIX
- K Number
- K013391
- 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
- October 15, 2001
- Decision Date
- January 11, 2002
- 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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Other Clearances by Medical Intelligence Medizintechnik GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K143485 | iGuide 2.1 | Mar 4, 2015 | Substantially Equivalent |
| K121530 | BODYFIX SYSTEM | Jun 20, 2012 | Substantially Equivalent |
| K112210 | FRAXION | Nov 22, 2011 | Substantially Equivalent |
| K072898 | HEXAPOD EVO RT COUCH TOP | Oct 25, 2007 | Substantially Equivalent |
| 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 |