FDA 510(k)

TomoTherapy Treatment Delivery System with iDMS

K-Number: K171837 · 2017-07-25

Decision Date2017-07-25

Product CodeIYE

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

TomoTherapy Treatment Delivery System with iDMS is a medical device manufactured by Accuray Incorporated. It received FDA 510(k) clearance on 2017-07-25 under approval number K171837. 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 TomoTherapy Treatment Delivery System with iDMS?

TomoTherapy Treatment Delivery System with iDMS is a medical device that received FDA 510(k) clearance on 2017-07-25. It is manufactured by Accuray Incorporated. The 510(k) number is K171837.

When was TomoTherapy Treatment Delivery System with iDMS approved by the FDA?

TomoTherapy Treatment Delivery System with iDMS received FDA 510(k) clearance on 2017-07-25, under approval number K171837.

What company makes TomoTherapy Treatment Delivery System with iDMS?

TomoTherapy Treatment Delivery System with iDMS is manufactured by Accuray Incorporated.

What is the FDA product code for TomoTherapy Treatment Delivery System with iDMS?

The FDA product code for TomoTherapy Treatment Delivery System with iDMS 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.