Precision Treatment Planning System
FDA 510(k) K161136 · Accuray Incorporated
510(k) numberK161136
Submission
- Device name
- Precision Treatment Planning System
- Applicant
- Accuray Incorporated
Sunnyvale, CA, US - Received
- April 22, 2016
- Decision date
- June 24, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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More from RaySearch Laboratories AB (PUBL)
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| K223159 | Radixact Treatment Delivery SystemIYE · Traditional | 06/23/2023SE |
| K212794 | Accuray Precision Treatment Planning SystemIYE · Special | 09/30/2021SE |
| K202412 | ClearRT Helical kVCT for the Radixact Treatment Delivery SystemIYE · Traditional | 12/18/2020SE |
| K182687 | Motion Tracking and Compensation Feature for the Radixact Treatment Delivery SystemIYE · Traditional | 11/23/2018SE |
| K171837 | TomoTherapy Treatment Delivery System with iDMSIYE · Traditional | 07/25/2017SE |
| K171086 | Accuray Precision Treatment Planning SystemIYE · Traditional | 06/08/2017SE |
| K161146 | Radixact Treatment Delivery SystemIYE · Traditional | 06/24/2016SE |
| K161144 | iDMS Data Management SystemIYE · 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 Precision Treatment Planning System cleared by the FDA?
Precision Treatment Planning System (K161136) received a 510(k) decision of Substantially Equivalent on June 24, 2016, 63 days after the submission was received.
What is the product code of K161136?
The FDA product code is MUJ – System, Planning, Radiation Therapy Treatment, a Class II (moderate risk) device regulated under 21 CFR 892.5050.