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)

Radixact Treatment Delivery System

K-Number: K223159 · 2023-06-23

ApplicantAccuray Incorporated
Decision Date2023-06-23
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Radixact Treatment Delivery System is the device name listed in this FDA 510(k) record. The listed applicant is Accuray Incorporated. It received FDA 510(k) clearance on 2023-06-23 under 510(k) number K223159. 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 Radixact Treatment Delivery System?

Radixact Treatment Delivery System is a medical device that received FDA 510(k) clearance on 2023-06-23. The listed applicant is Accuray Incorporated. The 510(k) number is K223159.

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

Radixact Treatment Delivery System received FDA 510(k) clearance on 2023-06-23, under 510(k) number K223159.

Who is the listed applicant for Radixact Treatment Delivery System?

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

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

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

Other records listing Accuray Incorporated 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.

K212794Accuray Precision Treatment Planning SystemK202412ClearRT Helical kVCT for the Radixact Treatment Delivery SystemK182687Motion Tracking and Compensation Feature for the Radixact Treatment Delivery SystemK171837TomoTherapy Treatment Delivery System with iDMSK171086Accuray Precision Treatment Planning SystemK161146Radixact Treatment Delivery System

View all 9 devices →

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.

↑