IQM Integral Quality Monitor

GUDID B50510130

IQM is quality assurance device for medical linear accelerators for verifying the treatment beam.

iRT Systems GmbH

Accelerator system quality assurance device Accelerator system quality assurance device

• Primary Device ID: B50510130
• NIH Device Record Key: e9d70b3f-ee77-4682-9399-078b0b79a78f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IQM Integral Quality Monitor
• Version Model Number: 1013 (vers 1.3)
• Company DUNS: 342751065
• Company Name: iRT Systems GmbH
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +49261915450
• Email: support@i-rt.de
• Phone: +49261915450
• Email: support@i-rt.de

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B50510130 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162629

FDA Product Code

• IYE: Accelerator, Linear, Medical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-02-03