K252071 is an FDA 510(k) clearance for the RefleXion Medical Radiotherapy System, Reflexion X2. This device is classified as a Fludeoxyglucose F18-guided Radiation Therapy System (Class II - Special Controls, product code QVA).
Submitted by Reflexion Medical, Inc. (Hayward, US). The FDA issued a Cleared decision on December 18, 2025, 170 days after receiving the submission on July 1, 2025.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5060. A Fludeoxyglucose F18-guided Radiation Therapy System Is A Device That Combines The Functionality Of An Emission Computed Tomography Detection System And A Linear Accelerator. The Device Is Intended For Use With Approved Fludeoxyglucose F18. The Emission Computed Tomography Detection System Acquires Images Of Positron-emitting Fludeoxyglucose F18 For The Purpose Of Guiding The Delivery Of Megavoltage X-rays For Oncologic Treatment With Radiation Therapy Using An Fda Cleared, Authorized, Or Approved Linear Accelerator..
| 510(k) Number | K252071 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 01, 2025 |
| Decision Date | December 18, 2025 |
| Days to Decision | 170 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | QVA - Fludeoxyglucose F18-guided Radiation Therapy System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5060 |
| Definition | A Fludeoxyglucose F18-guided Radiation Therapy System Is A Device That Combines The Functionality Of An Emission Computed Tomography Detection System And A Linear Accelerator. The Device Is Intended For Use With Approved Fludeoxyglucose F18. The Emission Computed Tomography Detection System Acquires Images Of Positron-emitting Fludeoxyglucose F18 For The Purpose Of Guiding The Delivery Of Megavoltage X-rays For Oncologic Treatment With Radiation Therapy Using An Fda Cleared, Authorized, Or Approved Linear Accelerator. |