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FDA 510(k)

MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM

K-Number: K091146 · 2009-05-01

ApplicantAccuray, Inc.
Decision Date2009-05-01
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Accuray, Inc.. It received FDA 510(k) clearance on 2009-05-01 under 510(k) number K091146. 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 MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM?

MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM is a medical device that received FDA 510(k) clearance on 2009-05-01. The listed applicant is Accuray, Inc.. The 510(k) number is K091146.

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

MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM received FDA 510(k) clearance on 2009-05-01, under 510(k) number K091146.

Who is the listed applicant for MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM?

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

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

The FDA product code for MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM is MUJ.

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Other records listing Accuray, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K091999CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEMK062967CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEMK051941CYBERNIFE STEREOTACTIC RADIOSURGERY SYSTEMK041315CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPYK032345CYBERKNIFE SYSTEM FOR STEROTACTIC RADIOSURGERY/RADIOTHERAPYK020294MOTION TRACKING

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Related Devices (Code: MUJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260750Virtual Cone (1.0)Varian Medical Systems, Inc.K253050RadOncAIInformaiK260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V.K252784eXaSkin PlusAnatomical Geometry S.L.K253078ART.1-USSeetreat Pty, Ltd.K252304syngo.via RT Image Suite VC10Varian Medical Systems, Inc.

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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