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U.S. Department of Health and Human Services

Product Classification

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Device fludeoxyglucose f18-guided radiation therapy system
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.
Physical State Combination linear accelerator and PET imaging system with software to allow for fludeoxyglucose F18-guided radiation therapy.
Technical Method Input from fludeoxyglucose F18 PET images acquired using this device acts a biological fiducial marker in order to guide oncologic radiation therapy treatment.
Target Area Fludeoxyglucose F18-avid tumors.
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodeQVA
Premarket Review Office of Radiological Health (OHT8)
Division of Radiological Imaging and Radiation Therapy Devices (DHT8C)
Submission Type 510(k)
Regulation Number 892.5060
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible