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Fludeoxyglucose F18-Guided Radiation Therapy System

Fludeoxyglucose F18-Guided Radiation Therapy System is a medical device type in the Radiology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.

Global Registration Data
Multi-Country Intelligence
Fludeoxyglucose F18-Guided Radiation Therapy System
Radiology Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

QVA

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Class 2

21 CFR 892.5060

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Radiology

Device Characteristics

No

No

No

Not Eligible

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.