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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 a medical device manufactured by Accuray Incorporated. It received FDA 510(k) clearance on 2023-06-23 under approval 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. It is manufactured by Accuray Incorporated. The 510(k) number is K223159.

When was Radixact Treatment Delivery System approved by the FDA?

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

What company makes Radixact Treatment Delivery System?

Radixact Treatment Delivery System is manufactured by Accuray Incorporated.

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

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

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Related PubMed Literature

PMID: 41483832 Emerging nanodelivery systems for cuproptosis induction: design strategies and multidimensional regulatory mechanisms. International journal of pharmaceutics (2026) PMID: 41251011 Effectivity of the Dehydrated Human Amnion/Chorion Membrane Allograft for Diabetic Foot Ulcers in Japan: A Case Series. International wound journal (2025) PMID: 40965839 A multi-stakeholder perspective on medical devices for children and adolescents with type 1 diabetes: huge unmet needs for the smallest. Journal of pediatric endocrinology & metabolism : JPEM (2025) PMID: 40258332 Chronic expanding hematoma following Gamma Knife irradiation for primary central nervous system lymphoma: illustrative case. Journal of neurosurgery. Case lessons (2025)

Other Devices by Accuray Incorporated

K161136Precision Treatment Planning System K161146Radixact Treatment Delivery System K161144iDMS Data Management System K171837TomoTherapy Treatment Delivery System with iDMS K171086Accuray Precision Treatment Planning System K182687Motion Tracking and Compensation Feature for the Radixact Treatment Delivery System

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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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