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FDA 510(k)

CyberKnife Treatment Delivery System

K-Number: K170788 · 2017-04-11

ApplicantAccuray Incorportaed
Decision Date2017-04-11
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CyberKnife Treatment Delivery System is the device name listed in this FDA 510(k) record. The listed applicant is Accuray Incorportaed. It received FDA 510(k) clearance on 2017-04-11 under 510(k) number K170788. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CyberKnife Treatment Delivery System?

CyberKnife Treatment Delivery System is a medical device that received FDA 510(k) clearance on 2017-04-11. The listed applicant is Accuray Incorportaed. The 510(k) number is K170788.

When did CyberKnife Treatment Delivery System receive FDA 510(k) clearance?

CyberKnife Treatment Delivery System received FDA 510(k) clearance on 2017-04-11, under 510(k) number K170788.

Who is the listed applicant for CyberKnife Treatment Delivery System?

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

What is the FDA product code for CyberKnife Treatment Delivery System?

The FDA product code for CyberKnife Treatment Delivery System is IYE.

Related Devices (Code: IYE)

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.

K261856Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc.K252937ThinkQA 3Dosisoft SAK253004LUNA 3DLap GmbH Laser ApplikationenK260792AerFrame Patient Immobilization System (AFPIS)Stabilix, LLCK252258VERIQA RT EPID 3DPtw-Freiburg Physikalisch-Technische-Werkstaetten Dr. PychlaK253962ClearCheck (RADCC V2.7)Radformation, 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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