FDA Product Code QVA: Fludeoxyglucose F18-guided Radiation Therapy System
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.
Leading manufacturers include Reflexion Medical, Inc..
FDA 510(k) Cleared Fludeoxyglucose F18-guided Radiation Therapy System Devices (Product Code QVA)
About Product Code QVA - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code QVA since 2023, with 1 receiving FDA clearance (average review time: 257 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under QVA have taken an average of 170 days to reach a decision - down from 343 days historically, suggesting improved FDA processing for this classification.
QVA devices are reviewed by the Radiology panel. Browse all Radiology devices →