FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
HEXAPOD RT COUCHTOP
K Number: K041448
·
Decision Jun 16, 2004
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
31
Applicant Total
8
Review Days
15
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Basic Information
- Device Name
- HEXAPOD RT COUCHTOP
- K Number
- K041448
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5770
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medical Intelligence Medizintechnik GmbH
- Date Received
- June 1, 2004
- Decision Date
- June 16, 2004
- Product Code
- JAI
- 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 |
|---|---|---|---|
| JAI | Couch, Radiation Therapy, Powered | 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 |
| K030439 | HEADFIX | May 8, 2003 | Substantially Equivalent |
| K013391 | BODYFIX | Jan 11, 2002 | Substantially Equivalent |