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Fludeoxyglucose F18-Guided Radiation Therapy System

FDA product code QVA · 1 cleared devices

Class 2 Radiology
Regulation
21 CFR 892.5060
Review panel
RA
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2025-12-18 – 2025-12-18

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.

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