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FDA 510(k)

CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY

K-Number: K052325 · 2005-09-14

ApplicantAccuray Incorporated
Decision Date2005-09-14
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY is the device name listed in this FDA 510(k) record. The listed applicant is Accuray Incorporated. It received FDA 510(k) clearance on 2005-09-14 under 510(k) number K052325. 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 CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY?

CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY is a medical device that received FDA 510(k) clearance on 2005-09-14. The listed applicant is Accuray Incorporated. The 510(k) number is K052325.

When did CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY receive FDA 510(k) clearance?

CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY received FDA 510(k) clearance on 2005-09-14, under 510(k) number K052325.

Who is the listed applicant for CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY?

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 SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY?

The FDA product code for CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY is MUJ.

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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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