RefleXion Medical Radiotherapy System
FDA 510(k) K190978 · Reflexion Medical, Inc.
510(k) numberK190978
Submission
- Device name
- RefleXion Medical Radiotherapy System
- Applicant
- Reflexion Medical, Inc.
Hayward, CA, US - Received
- April 15, 2019
- Decision date
- March 12, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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More from Varian Medical Systems, Inc.
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|---|---|---|
| K252071 | RefleXion Medical Radiotherapy System, Reflexion X2QVA · Traditional | 12/18/2025SE |
Questions and answers
When was RefleXion Medical Radiotherapy System cleared by the FDA?
RefleXion Medical Radiotherapy System (K190978) received a 510(k) decision of Substantially Equivalent on March 12, 2020, 332 days after the submission was received.
What is the product code of K190978?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.