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FDA 510(k)

CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM

K-Number: K102650 · 2010-11-17

ApplicantAccuray Incorporated
Decision Date2010-11-17
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Accuray Incorporated. It received FDA 510(k) clearance on 2010-11-17 under 510(k) number K102650. 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 CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM?

CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM is a medical device that received FDA 510(k) clearance on 2010-11-17. The listed applicant is Accuray Incorporated. The 510(k) number is K102650.

When did CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM receive FDA 510(k) clearance?

CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM received FDA 510(k) clearance on 2010-11-17, under 510(k) number K102650.

Who is the listed applicant for CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM?

The FDA 510(k) record lists Accuray Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM?

The FDA product code for CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM is IYE.

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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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