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FDA 510(k)

THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/ RADIOTHERAPY V2.1

K-Number: K000478 · 2000-04-19

ApplicantAccuray, Inc.
Decision Date2000-04-19
Product CodeIWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/ RADIOTHERAPY V2.1 is the device name listed in this FDA 510(k) record. The listed applicant is Accuray, Inc.. It received FDA 510(k) clearance on 2000-04-19 under 510(k) number K000478. The device is classified under product code IWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/ RADIOTHERAPY V2.1?

THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/ RADIOTHERAPY V2.1 is a medical device that received FDA 510(k) clearance on 2000-04-19. The listed applicant is Accuray, Inc.. The 510(k) number is K000478.

When did THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/ RADIOTHERAPY V2.1 receive FDA 510(k) clearance?

THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/ RADIOTHERAPY V2.1 received FDA 510(k) clearance on 2000-04-19, under 510(k) number K000478.

Who is the listed applicant for THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/ RADIOTHERAPY V2.1?

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 THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/ RADIOTHERAPY V2.1?

The FDA product code for THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/ RADIOTHERAPY V2.1 is IWB.

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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/RADIOTHERAPYK032345CYBERKNIFE SYSTEM FOR STEROTACTIC RADIOSURGERY/RADIOTHERAPY

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Related Devices (Code: IWB)

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.

K250391Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™)Elekta Solutions ABK232854Leksell GammaPlan (LGP)Elekta Solutions ABK222047Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant)Elekta Solutions ABK203250TaiChiCOur United CorporationK203146Akesis Galaxy RTiAkesis, Inc.K200050Akesis Galaxy RTxAkesis, 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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