DEN220014 is an FDA 510(k) submission for the RefleXion Medical Radiotherapy System (RMRS). 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 Not Cleared (DENG) decision on February 1, 2023.
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 | DEN220014 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | February 23, 2022 |
| Decision Date | February 01, 2023 |
| Days to Decision | 343 days |
| Submission Type | Direct |
| Review Panel | Radiology (RA) |
| Summary | - |
| 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. |