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.

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• Primary Device ID: 00860003983812
• NIH Device Record Key: 9642ef6f-382c-447e-8a90-b0ef0d073751
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RefleXion Medical Radiotherapy System
• Version Model Number: RXM1000
• Company DUNS: 831659169
• Company Name: REFLEXION MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8665094001
• Email: TechSupport@reflexion.com
• Phone: 8665094001
• Email: TechSupport@reflexion.com
• Phone: 8665094001
• Email: TechSupport@reflexion.com
• Phone: 8665094001
• Email: TechSupport@reflexion.com
• Phone: 8665094001
• Email: TechSupport@reflexion.com
• Phone: 8665094001
• Email: TechSupport@reflexion.com
• Phone: 8665094001
• Email: TechSupport@reflexion.com
• Phone: 8665094001
• Email: TechSupport@reflexion.com
• Phone: 8665094001
• Email: TechSupport@reflexion.com
• Phone: 8665094001
• Email: TechSupport@reflexion.com
• Phone: 8665094001
• Email: TechSupport@reflexion.com
• Phone: 8665094001
• Email: TechSupport@reflexion.com
• Phone: 8665094001
• Email: TechSupport@reflexion.com
• Phone: 8665094001
• Email: TechSupport@reflexion.com
• Phone: 8665094001
• Email: TechSupport@reflexion.com
• Phone: 8665094001
• Email: TechSupport@reflexion.com
• Phone: 8665094001
• Email: TechSupport@reflexion.com
• Phone: 8665094001
• Email: TechSupport@reflexion.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860003983812 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN220014

FDA Product Code

• QVA: Fludeoxyglucose F18-Guided Radiation Therapy System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-01
• Device Publish Date: 2023-02-21

On-Brand Devices [RefleXion Medical Radiotherapy System]

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