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FDA 510(k)

RefleXion Medical Radiotherapy System

K-Number: K190978 · 2020-03-12

ApplicantReflexion Medical, Inc.
Decision Date2020-03-12
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RefleXion Medical Radiotherapy System is a medical device manufactured by Reflexion Medical, Inc.. It received FDA 510(k) clearance on 2020-03-12 under approval number K190978. 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 RefleXion Medical Radiotherapy System?

RefleXion Medical Radiotherapy System is a medical device that received FDA 510(k) clearance on 2020-03-12. It is manufactured by Reflexion Medical, Inc.. The 510(k) number is K190978.

When was RefleXion Medical Radiotherapy System approved by the FDA?

RefleXion Medical Radiotherapy System received FDA 510(k) clearance on 2020-03-12, under approval number K190978.

What company makes RefleXion Medical Radiotherapy System?

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

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

The FDA product code for RefleXion Medical Radiotherapy System is IYE.

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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.

DEN220014RefleXion Medical Radiotherapy System (RMRS) K252071RefleXion Medical Radiotherapy System, Reflexion X2

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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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