FDA 510(k)

ClearRT Helical kVCT for the Radixact Treatment Delivery System

K-Number: K202412 · 2020-12-18

Decision Date2020-12-18

Product CodeIYE

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

ClearRT Helical kVCT for the Radixact Treatment Delivery System is a medical device manufactured by Accuray Incorporated. It received FDA 510(k) clearance on 2020-12-18 under approval number K202412. 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 ClearRT Helical kVCT for the Radixact Treatment Delivery System?

ClearRT Helical kVCT for the Radixact Treatment Delivery System is a medical device that received FDA 510(k) clearance on 2020-12-18. It is manufactured by Accuray Incorporated. The 510(k) number is K202412.

When was ClearRT Helical kVCT for the Radixact Treatment Delivery System approved by the FDA?

ClearRT Helical kVCT for the Radixact Treatment Delivery System received FDA 510(k) clearance on 2020-12-18, under approval number K202412.

What company makes ClearRT Helical kVCT for the Radixact Treatment Delivery System?

ClearRT Helical kVCT for the Radixact Treatment Delivery System is manufactured by Accuray Incorporated.

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

The FDA product code for ClearRT Helical kVCT for the Radixact Treatment Delivery System is IYE.

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Other Devices by Accuray Incorporated

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Official Source

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