ORION System

Basic Information

• Brand Name: ORION System
• Primary DI: 03700383510048
• Version / Model: 1SOPT00006
• Catalog Number: 1SOPT00006
• Company Name: BIZLINK ROBOTIC SOLUTIONS FRANCE S.A.S.
• Labeler DUNS: 393677208
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-11-06
• Public Version: 1
• Public Version Date: 2024-11-14
• Public Version Status: New
• Public Device Record Key: 961d729f-0107-420d-b397-277ab294422f

Device Description

Electro-mechanical robotic arm for patient positioning in radiotherapy and medical imaging.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JAI	Couch, Radiation Therapy, Powered	Radiology	892.5770	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47236	Proton therapy system robotic patient positioner	A component of a proton therapy system (PTS) designed to adjust the position of a PTS treatment table/couch or chair enabling the operator to accurately position the patient and treatment target site in relation to the proton treatment beam. The device is programmable and typically consists of mechanical supports, drive motors, and control devices. This device is a PTS beam management system (BMS) and patient positioning system (PPS) component.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03700383510048	GS1

Premarket Submissions

Submission Number	Supplement Number
K160518	000