Reflexion Medical Radiotherapy System

GUDID 00860003983805

The RefleXion Medical Radiotherapy System (RMRS), a hybrid imaging-therapy system, is capable of delivering intensity-modulated radiation therapy (IMRT), stereotactic body radiation therapy (SBRT), stereotactic radiotherapy (SRT) and stereotactic radiosurgery (SRS) utilizing an on-board kilovoltage CT (kVCT) system for patient localization and field sizes based on jaws which are 40 cm wide, with slice width choices of 1.0 cm and 2.0 cm to optimize patient treatment. It is also equipped with a binary multileaf collimator (MLC) used to create intensity modulated radiation fields at a source-axis distance of 85 cm. It can achieve a nominal dose rate of 850 cGy/min.

REFLEXION MEDICAL, INC.

Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system

• Primary Device ID: 00860003983805
• NIH Device Record Key: dc61daaf-9d7b-4e9e-ab80-ce19f0c7ba0c
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860003983805 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190978

FDA Product Code

• IYE: Accelerator, Linear, Medical

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: 2021-03-02
• Device Publish Date: 2021-02-22

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