TBI Detector 110V

Basic Information

• Brand Name: TBI Detector 110V
• Primary DI: 08717953004031
• Version / Model: C01-05-02
• Catalog Number: C01-05-02
• Company Name: Cablon Medical B.V.
• Labeler DUNS: 415163591
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-11-11
• Public Version: 1
• Public Version Date: 2024-11-19
• Public Version Status: New
• Public Device Record Key: 081da2e2-2a3f-48dd-8754-69daedadc588

Device Description

The TBI Detector is used in radiation therapy clinics to acquire MV images by means of an imaging device, in order to be forwarded to the Theraview imaging software.

Device Characteristics

• Single Use: Yes
• 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: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IYE	Accelerator, Linear, Medical	Radiology	892.5050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45064	Radiation therapy digital imager	An automated device that is typically mounted on the gantry of a linear accelerator and intended to produce digital images of x-rayed anatomical landmarks to guide radiation treatment (e.g., tracking/targeting tumours). The device may be a digital imaging panel (e.g., of silicon) on robotic arms; it may also have an x-ray source to generate higher quality images.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08717953004031	GS1

Premarket Submissions

Submission Number	Supplement Number
K960510	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 80 Degrees Celsius