RefleXion Medical Radiotherapy System

GUDID 00860003983812

The RefleXion Medical Radiotherapy System is indicated for treatment planning and precise delivery of image-guided radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery for tumors or other targeted tissues anywhere in the body when radiation treatment is indicated, while minimizing the delivery of radiation to vital healthy tissue. The megavoltage X-ray radiation is delivered in a rotational, modulated, image-guided format in accordance with the physician approved plan. The RefleXion Medical Radiotherapy System is also indicated for FDG-guided treatment which includes modeling, planning and precise delivery of FDG-guided radiation therapy, a type of Biology-guided Radiotherapy (BgRT), in five or fewer fractions for adults. It is indicated for tumor volumes in lung and bone subject to potential motion and positional uncertainty that have each been assessed with on-board PET/CT prior to delivery for adequate localization, sufficient FDG metabolic activity, local contrast and consistent biodistribution to meet the RMRS requirements, while minimizing the delivery of radiation to vital healthy tissue. BgRT involves the detection of signals from F18 during active beam delivery as a guide to deliver megavoltage X-ray radiotherapy in a rotational, modulated format in accordance with a physician approved treatment plan. For complete fludeoxyglucose F18 prescribing information, refer both to the current medical imaging agent labeling and to this device labeling under “FDG Medical Imaging Agent Information”.

REFLEXION MEDICAL, INC.

Linear accelerator system
Primary Device ID00860003983812
NIH Device Record Key9642ef6f-382c-447e-8a90-b0ef0d073751
Commercial Distribution StatusIn Commercial Distribution
Brand NameRefleXion Medical Radiotherapy System
Version Model NumberRXM1000
Company DUNS831659169
Company NameREFLEXION MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8665094001
EmailTechSupport@reflexion.com
Phone8665094001
EmailTechSupport@reflexion.com
Phone8665094001
EmailTechSupport@reflexion.com
Phone8665094001
EmailTechSupport@reflexion.com
Phone8665094001
EmailTechSupport@reflexion.com
Phone8665094001
EmailTechSupport@reflexion.com
Phone8665094001
EmailTechSupport@reflexion.com
Phone8665094001
EmailTechSupport@reflexion.com
Phone8665094001
EmailTechSupport@reflexion.com
Phone8665094001
EmailTechSupport@reflexion.com
Phone8665094001
EmailTechSupport@reflexion.com
Phone8665094001
EmailTechSupport@reflexion.com
Phone8665094001
EmailTechSupport@reflexion.com
Phone8665094001
EmailTechSupport@reflexion.com
Phone8665094001
EmailTechSupport@reflexion.com
Phone8665094001
EmailTechSupport@reflexion.com
Phone8665094001
EmailTechSupport@reflexion.com
Phone8665094001
EmailTechSupport@reflexion.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100860003983812 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QVAFludeoxyglucose F18-Guided Radiation Therapy System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-01
Device Publish Date2023-02-21

On-Brand Devices [RefleXion Medical Radiotherapy System]

00860003983805The RefleXion Medical Radiotherapy System (RMRS), a hybrid imaging-therapy system, is capable of
00860003983812The RefleXion Medical Radiotherapy System is indicated for treatment planning and precise delive

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