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FDA 510(k)

Radixact Treatment Delivery System

K-Number: K161146 · 2016-06-24

ApplicantAccuray Incorporated
Decision Date2016-06-24
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Radixact Treatment Delivery System is a medical device manufactured by Accuray Incorporated. It received FDA 510(k) clearance on 2016-06-24 under approval number K161146. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Radixact Treatment Delivery System?

Radixact Treatment Delivery System is a medical device that received FDA 510(k) clearance on 2016-06-24. It is manufactured by Accuray Incorporated. The 510(k) number is K161146.

When was Radixact Treatment Delivery System approved by the FDA?

Radixact Treatment Delivery System received FDA 510(k) clearance on 2016-06-24, under approval number K161146.

What company makes Radixact Treatment Delivery System?

Radixact Treatment Delivery System is manufactured by Accuray Incorporated.

What is the FDA product code for Radixact Treatment Delivery System?

The FDA product code for Radixact Treatment Delivery System is IYE.

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Related PubMed Literature

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Other Devices by Accuray Incorporated

K161136Precision Treatment Planning System K161144iDMS Data Management System K171837TomoTherapy Treatment Delivery System with iDMS K171086Accuray Precision Treatment Planning System K182687Motion Tracking and Compensation Feature for the Radixact Treatment Delivery System K202412ClearRT Helical kVCT for the Radixact Treatment Delivery System

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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