Fludeoxyglucose F18-Guided Radiation Therapy System
QVA · Class II — Moderate Risk (510(k) clearance required) · Radiology · 21 CFR 892.5060
Classification
FDA Product Code
QVA
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 892.5060
Review panel
RA
Medical specialty
Radiology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.