PIM Portable Hand Palm Scanner C01-09-03

GUDID 08717953004055

The Patient Identification Module (PIM) is used in radiation therapy clinics to verify the patient's identity prior to treatment by means of a portable sensor, in order to prevent patient mix-ups. An interlock disables the LINAC and treatment will not start so long as the patient is not successfully identified.

Cablon Medical B.V.

Radiation therapy treatment record/verify system

• Primary Device ID: 08717953004055
• NIH Device Record Key: 231863b8-d7fe-475a-9e33-76a8a37f7278
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PIM Portable Hand Palm Scanner
• Version Model Number: C01-09-03
• Catalog Number: C01-09-03
• 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: false
• 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

Customer Support Contacts

• Phone: +31334943964
• Email: monique.albinus@cablon.nl
• Phone: +31334943964
• Email: monique.albinus@cablon.nl
• Phone: +31334943964
• Email: monique.albinus@cablon.nl
• Phone: +31334943964
• Email: monique.albinus@cablon.nl
• Phone: +31334943964
• Email: monique.albinus@cablon.nl
• Phone: +31334943964
• Email: monique.albinus@cablon.nl
• Phone: +31334943964
• Email: monique.albinus@cablon.nl
• Phone: +31334943964
• Email: monique.albinus@cablon.nl
• Phone: +31334943964
• Email: monique.albinus@cablon.nl
• Phone: +31334943964
• Email: monique.albinus@cablon.nl
• Phone: +31334943964
• Email: monique.albinus@cablon.nl
• Phone: +31334943964
• Email: monique.albinus@cablon.nl
• Phone: +31334943964
• Email: monique.albinus@cablon.nl
• Phone: +31334943964
• Email: monique.albinus@cablon.nl
• Phone: +31334943964
• Email: monique.albinus@cablon.nl
• Phone: +31334943964
• Email: monique.albinus@cablon.nl
• Phone: +31334943964
• Email: monique.albinus@cablon.nl

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	08717953004055 [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: 2024-11-19 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: 2024-11-19The Patient Identification Module (PIM) is used in radiation therapy clinics to verify the patient's identity prior to treatment by means of a portable sensor, in order to prevent patient mix-ups. An interlock disables the LINAC and treatment will not start so long as the patient is not successfully identified.
• 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