Fludeoxyglucose F18-Guided Radiation Therapy System
The Fludeoxyglucose F18-Guided Radiation Therapy System is a device that combines emission computed tomography (PET) imaging with a linear accelerator to acquire real-time positron-emission images of FDG F18 uptake in tumors and use that data to guide the delivery of megavoltage X-ray radiation therapy for oncologic treatment. It enables biologically guided radiotherapy based on metabolic tumor activity. Classified as FDA Class 2 under regulation 892.5060, it requires 510(k) clearance in the Radiology specialty. The device is not an implant and not life-sustaining.
Basic Information
- Product Code
- QVA
- Device Class
- FDA class 2
- Regulation Number
- 892.5060
- Medical Specialty
- Radiology
- Review Panel
- RA
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN220014 | RefleXion Medical Radiotherapy System (RMRS) | Feb 01, 2023 | Unknown | RefleXion Medical Inc |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.