HEXAPOD EVO RT COUCH TOP
FDA 510(k) clearance K072898 · decided 2007-10-25
Clearance details
- K-number
- K072898
- Device name
- HEXAPOD EVO RT COUCH TOP
- Applicant
- Medical Intelligence Medizintechnik GmbH
- Decision
- Substantially Equivalent
- Date received
- 2007-10-11
- Decision date
- 2007-10-25
- Days to decision
- 14 days
- Clearance type
- Special
- Product code
- JAI
- Device class
- 2
- Regulation number
- 892.5770
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Schwabmuenchen, DE
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| HexaPOD evo RT Couchtop. To support and aid in positioning a patient during radiation ther recall (Z-1514-2014) | Elekta, Inc. | 2014-04-25 |