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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 a medical device manufactured by Reflexion Medical, Inc.. It received FDA 510(k) clearance on 2025-12-18 under approval 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. It is manufactured by Reflexion Medical, Inc.. The 510(k) number is K252071.

When was RefleXion Medical Radiotherapy System, Reflexion X2 approved by the FDA?

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

What company makes RefleXion Medical Radiotherapy System, Reflexion X2?

RefleXion Medical Radiotherapy System, Reflexion X2 is manufactured by Reflexion Medical, Inc..

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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Related PubMed Literature

PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026) PMID: 41879133 Medical Device Regulation - Who Does the FDA Serve? The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026)

Other Devices by Reflexion Medical, Inc.

K190978RefleXion Medical Radiotherapy System DEN220014RefleXion Medical Radiotherapy System (RMRS)

Related Devices (Code: QVA)

DEN220014RefleXion Medical Radiotherapy System (RMRS)Reflexion Medical, 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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