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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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.
Product CodeQVA
Regulation Number 892.5060
Device Class 2


Premarket Reviews
ManufacturerDecision
REFLEXION MEDICAL INC
  GRANTED 1

MDR Year MDR Reports MDR Events
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Patient Device Interaction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Encephalopathy 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Reflexion Medical, Inc. II May-30-2024
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