TBI Detector 110V C01-05-02

GUDID 08717953004031

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.

Cablon Medical B.V.

Radiation therapy digital imager

• Primary Device ID: 08717953004031
• NIH Device Record Key: 081da2e2-2a3f-48dd-8754-69daedadc588
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TBI Detector 110V
• Version Model Number: C01-05-02
• Catalog Number: C01-05-02
• Company DUNS: 415163591
• Company Name: Cablon Medical B.V.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 80 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 80 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 80 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 80 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 80 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 80 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 80 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 80 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 80 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 80 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 80 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 80 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 80 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 80 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 80 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 80 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 80 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08717953004031 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K960510

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: 2024-11-19
• Device Publish Date: 2024-11-11

Devices Manufactured by Cablon Medical B.V.

• 08717953004000 - Theraview: 2024-11-19 The Theraview software is used in radiation therapy clinics to acquire Megavoltage (MV) and/ or kiloVoltage (kV) images by means
• 08717953004031 - TBI Detector 110V: 2024-11-19The 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.
• 08717953004031 - TBI Detector 110V: 2024-11-19 The TBI Detector is used in radiation therapy clinics to acquire MV images by means of an imaging device, in order to be forward
• 08717953004048 - PIM Fixed Hand Palm Scanner: 2024-11-19 The Patient Identification Module (PIM) is used in radiation therapy clinics to verify the patient's identity prior to treatment
• 08717953004055 - PIM Portable Hand Palm Scanner: 2024-11-19 The Patient Identification Module (PIM) is used in radiation therapy clinics to verify the patient's identity prior to treatment