FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
HEXAPOD EVO RT COUCH TOP
K Number: K072898
·
Decision Oct 25, 2007
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
31
Applicant Total
8
Review Days
14
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- HEXAPOD EVO RT COUCH TOP
- K Number
- K072898
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.5770
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medical Intelligence Medizintechnik GmbH
- Date Received
- October 11, 2007
- Decision Date
- October 25, 2007
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JAI), ordered by most recent decision date.
Eve Patient Positioner System
FDA 510(k)
FDA Class 2
·Radiology
Z-Robot Patient Positioning System
FDA 510(k)
FDA Class 2
·Radiology
Patient Positioning System
FDA 510(k)
FDA Class 2
·Radiology
LEONI ORION System
FDA 510(k)
FDA Class 2
·Radiology
PROTURA COUCH SOFTWARE
FDA 510(k)
FDA Class 2
·Radiology
PATIENT POSITIONING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
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 |
| 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 |