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FDA 510(k)

RefleXion Medical Radiotherapy System, Reflexion X2

K-Number: K252071 · 2025-12-18

ApplicantReflexion Medical, Inc.
Decision Date2025-12-18
Product CodeQVA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RefleXion Medical Radiotherapy System, Reflexion X2 is the device name listed in this FDA 510(k) record. The listed applicant is Reflexion Medical, Inc.. It received FDA 510(k) clearance on 2025-12-18 under 510(k) number K252071. The device is classified under product code QVA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RefleXion Medical Radiotherapy System, Reflexion X2?

RefleXion Medical Radiotherapy System, Reflexion X2 is a medical device that received FDA 510(k) clearance on 2025-12-18. The listed applicant is Reflexion Medical, Inc.. The 510(k) number is K252071.

When did RefleXion Medical Radiotherapy System, Reflexion X2 receive FDA 510(k) clearance?

RefleXion Medical Radiotherapy System, Reflexion X2 received FDA 510(k) clearance on 2025-12-18, under 510(k) number K252071.

Who is the listed applicant for RefleXion Medical Radiotherapy System, Reflexion X2?

The FDA 510(k) record lists Reflexion Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RefleXion Medical Radiotherapy System, Reflexion X2?

The FDA product code for RefleXion Medical Radiotherapy System, Reflexion X2 is QVA.

Related Clinical Trials

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NCT05470699RefleXion PET/CT Imaging Performance in Patients With Prostate CancerACTIVE_NOT_RECRUITING

Other records listing Reflexion Medical, 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.

K190978RefleXion Medical Radiotherapy System

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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