Motion Tracking and Compensation Feature for the Radixact Treatment Delivery System
FDA 510(k) K182687 · Accuray Incorporated
510(k) numberK182687
Submission
- Device name
- Motion Tracking and Compensation Feature for the Radixact Treatment Delivery System
- Applicant
- Accuray Incorporated
Madison, WI, US - Received
- September 26, 2018
- Decision date
- November 23, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K161144 | iDMS Data Management SystemIYE · Traditional | 06/24/2016SE |
| K161136 | Precision Treatment Planning SystemMUJ · Traditional | 06/24/2016SE |
| K152488 | Onrad Treatment SystemMUJ · Special | 09/28/2015SE |
| K150873 | CyberKnife M6 FI Sytem, CyberKnife M6 FM System, CyberKnife M6 FIM SystemIYE · Traditional | 07/01/2015SE |
Questions and answers
When was Motion Tracking and Compensation Feature for the Radixact Treatment Delivery System cleared by the FDA?
Motion Tracking and Compensation Feature for the Radixact Treatment Delivery System (K182687) received a 510(k) decision of Substantially Equivalent on November 23, 2018, 58 days after the submission was received.
What is the product code of K182687?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.