ORION System 1SOPT00010

GUDID 03700383510086

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

BIZLINK ROBOTIC SOLUTIONS FRANCE S.A.S.

Proton therapy system robotic patient positioner

• Primary Device ID: 03700383510086
• NIH Device Record Key: 521e17f2-e191-413e-8b69-515540a2238c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ORION System
• Version Model Number: 1SOPT00010
• Catalog Number: 1SOPT00010
• Company DUNS: 393677208
• Company Name: BIZLINK ROBOTIC SOLUTIONS FRANCE S.A.S.
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700383510086 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160518

FDA Product Code

• JAI: Couch, Radiation Therapy, Powered

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: 2024-11-14
• Device Publish Date: 2024-11-06

On-Brand Devices [ORION System]

• 03700383510178: Electro-mechanical robotic arm for patient positioning in radiotherapy and medical imaging.
• 03700383510154: Electro-mechanical robotic arm for patient positioning in radiotherapy and medical imaging.
• 03700383510086: Electro-mechanical robotic arm for patient positioning in radiotherapy and medical imaging.
• 03700383510079: Electro-mechanical robotic arm for patient positioning in radiotherapy and medical imaging.
• 03700383510048: Electro-mechanical robotic arm for patient positioning in radiotherapy and medical imaging.
• 03700383510031: Electro-mechanical robotic arm for patient positioning in radiotherapy and medical imaging.
• 03700383510017: Electro-mechanical robotic arm for patient positioning in radiotherapy and medical imaging.
• 03700383510000: Electro-mechanical robotic arm for patient positioning in radiotherapy and medical imaging.