510(k) K252071
K252071 is an FDA 510(k) premarket notification submitted by Reflexion Medical, Inc. for the device "RefleXion Medical Radiotherapy System, Reflexion X2". The FDA issued a decision of Substantially Equivalent on December 18, 2025. 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
- SESE (Substantially Equivalent)
- Decision Date
- December 18, 2025
- Date Received
- July 1, 2025
- Clearance Type
- Traditional
- 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.