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

• 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