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FDA 510(k)

Precision Treatment Planning System

K-Number: K161136 · 2016-06-24

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

Device Summary

Precision Treatment Planning System is a medical device manufactured by Accuray Incorporated. It received FDA 510(k) clearance on 2016-06-24 under approval number K161136. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Precision Treatment Planning System?

Precision Treatment Planning 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 K161136.

When was Precision Treatment Planning System approved by the FDA?

Precision Treatment Planning System received FDA 510(k) clearance on 2016-06-24, under approval number K161136.

What company makes Precision Treatment Planning System?

Precision Treatment Planning System is manufactured by Accuray Incorporated.

What is the FDA product code for Precision Treatment Planning System?

The FDA product code for Precision Treatment Planning System is MUJ.

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Other Devices by Accuray Incorporated

K161146Radixact Treatment Delivery 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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