Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CYBERNIFE STEREOTACTIC RADIOSURGERY SYSTEM

K-Number: K051941 · 2005-08-09

ApplicantAccuray, Inc.
Decision Date2005-08-09
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CYBERNIFE STEREOTACTIC 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 2005-08-09 under 510(k) number K051941. 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 CYBERNIFE STEREOTACTIC RADIOSURGERY SYSTEM?

CYBERNIFE STEREOTACTIC RADIOSURGERY SYSTEM is a medical device that received FDA 510(k) clearance on 2005-08-09. The listed applicant is Accuray, Inc.. The 510(k) number is K051941.

When did CYBERNIFE STEREOTACTIC RADIOSURGERY SYSTEM receive FDA 510(k) clearance?

CYBERNIFE STEREOTACTIC RADIOSURGERY SYSTEM received FDA 510(k) clearance on 2005-08-09, under 510(k) number K051941.

Who is the listed applicant for CYBERNIFE STEREOTACTIC 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 CYBERNIFE STEREOTACTIC RADIOSURGERY SYSTEM?

The FDA product code for CYBERNIFE STEREOTACTIC RADIOSURGERY SYSTEM is MUJ.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 SYSTEMK041315CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPYK032345CYBERKNIFE SYSTEM FOR STEROTACTIC RADIOSURGERY/RADIOTHERAPYK020294MOTION TRACKING

View all 10 devices →

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.

↑