iBEAM

Basic Information

• Brand Name: iBEAM
• Primary DI: 04056719000950
• Version / Model: P10105-101
• Catalog Number: P10105-101
• Company Name: 3C-Medical Intelligence GmbH
• Labeler DUNS: 314546664
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-23
• Public Version: 5
• Public Version Date: 2023-12-15
• Public Version Status: Update
• Public Device Record Key: f70490d6-cedc-4b55-8a32-274ec17f8039
• Distribution End Date: 2020-12-09

Device Description

Couch Top

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: Yes
• 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
IXQ	Table, Radiographic, Stationary Top	Radiology	892.1980	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40686	Accelerator system table, non-powered	A non-electrical radiotherapy device that is a component of an accelerator system specifically designed to position and support a patient, typically supine, during therapeutic radiation treatments administered using a medical linear accelerator or non-linear accelerator. It is a flat surface on legs with fixed position top or mechanical top positioning and/or height controls (e.g., pneumatic controls, magnetic locks, cranks and lever mechanisms). It may be an independent device that is stationary or mobile, or it can be an integral component of a medical accelerator system design.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04056719000950	GS1