ROBOCOUCH PATIENT SUPPORT SYSTEM
FDA 510(k) clearance K042146 · decided 2004-09-17
Clearance details
- K-number
- K042146
- Device name
- ROBOCOUCH PATIENT SUPPORT SYSTEM
- Applicant
- Accuray Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2004-08-09
- Decision date
- 2004-09-17
- Days to decision
- 39 days
- Clearance type
- Traditional
- Product code
- JAI
- Device class
- 2
- Regulation number
- 892.5770
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| RoboCouch Patient Positioning System Product Usage: is intended for use in the support and recall (Z-1155-2013) | Accuray Incorporated | 2013-04-20 |
| RoboCouch Patient Support System, model number 025007, a subsystem of the Cyberknife Robot recall (Z-0853-2011) | Accuray Inc | 2011-01-11 |
| RoboCouch Patient Support System, a component of the CyberKnife Robotic Radiosurgery Syste recall (Z-0856-2009) | Accuray Inc | 2009-01-14 |