510(k) DEN220014
DEN220014 is an FDA 510(k) premarket notification submitted by Reflexion Medical, Inc. for the device "RefleXion Medical Radiotherapy System (RMRS)". The FDA issued a decision of De Novo Granted on February 1, 2023. The device falls under product code QVA (Fludeoxyglucose F18-Guided Radiation Therapy System), a Class II device regulated under 21 CFR 892.5060. Reflexion Medical, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- February 1, 2023
- Date Received
- February 23, 2022
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fludeoxyglucose F18-Guided Radiation Therapy System
- Device Class
- Class II
- Regulation Number
- 892.5060
- Review Panel
- RA
- Submission Type
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.