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FDA 510(k)

CYBERKNIFE SYSTEM FOR STEROTACTIC RADIOSURGERY/RADIOTHERAPY

K-Number: K032345 · 2003-09-03

ApplicantAccuray, Inc.
Decision Date2003-09-03
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CYBERKNIFE SYSTEM FOR STEROTACTIC RADIOSURGERY/RADIOTHERAPY is the device name listed in this FDA 510(k) record. The listed applicant is Accuray, Inc.. It received FDA 510(k) clearance on 2003-09-03 under 510(k) number K032345. 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 STEROTACTIC RADIOSURGERY/RADIOTHERAPY?

CYBERKNIFE SYSTEM FOR STEROTACTIC RADIOSURGERY/RADIOTHERAPY is a medical device that received FDA 510(k) clearance on 2003-09-03. The listed applicant is Accuray, Inc.. The 510(k) number is K032345.

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

CYBERKNIFE SYSTEM FOR STEROTACTIC RADIOSURGERY/RADIOTHERAPY received FDA 510(k) clearance on 2003-09-03, under 510(k) number K032345.

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

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 CYBERKNIFE SYSTEM FOR STEROTACTIC RADIOSURGERY/RADIOTHERAPY?

The FDA product code for CYBERKNIFE SYSTEM FOR STEROTACTIC RADIOSURGERY/RADIOTHERAPY 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 SYSTEMK091146MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEMK062967CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEMK051941CYBERNIFE STEREOTACTIC RADIOSURGERY SYSTEMK041315CYBERKNIFE SYSTEM FOR STEREOTACTIC 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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