CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM— 510(k) K091999
Substantially EquivalentAccuray, Inc.
FDA 510(k) clearance K091999 for CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM, Substantially Equivalent on 2009-09-18. Applicant: Accuray, Inc.. Device class: 2.
Clearance details
- Applicant
- Accuray, Inc.
- Product code
- Code IYE
- Device class
- Class 2
- Regulation
- 21 CFR 892.5050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Sunnyvale, CA, US
Recent devices under product code IYE
view allMore clearances from Accuray, Inc.
view all- K091146 — MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
- K062967 — CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
- K051941 — CYBERNIFE STEREOTACTIC RADIOSURGERY SYSTEM
- K041315 — CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY
- K032345 — CYBERKNIFE SYSTEM FOR STEROTACTIC RADIOSURGERY/RADIOTHERAPY
Adverse events under product code IYE
product code IYE- Malfunction
- 455
- Other
- 3
- Total
- 458
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.