ClearRT Helical kVCT for the Radixact Treatment Delivery System— 510(k) K202412
Substantially EquivalentAccuray Incorporated
FDA 510(k) clearance K202412 for ClearRT Helical kVCT for the Radixact Treatment Delivery System, Substantially Equivalent on 2020-12-18. Applicant: Accuray Incorporated. Device class: 2.
Clearance details
- Applicant
- Accuray Incorporated
- 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
- Traditional
- Location
- Madison, WI, US
Recent devices under product code IYE
view allMore clearances from Accuray Incorporated
view all- K223159 — Radixact Treatment Delivery System
- K212794 — Accuray Precision Treatment Planning System
- K182687 — Motion Tracking and Compensation Feature for the Radixact Treatment Delivery System
- K171837 — TomoTherapy Treatment Delivery System with iDMS
- K171086 — Accuray Precision Treatment Planning System
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.