icompanion

GUDID B621ICOMPANION103

icometrix NV

Radiology DICOM image processing application software

• Primary Device ID: B621ICOMPANION103
• NIH Device Record Key: 2b7f5241-d438-43c9-80c8-3c4466ac1fa1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: icompanion
• Version Model Number: 1
• Company DUNS: 400793486
• Company Name: icometrix NV
• 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: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B621ICOMPANION103 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161148

FDA Product Code

• LLZ: System, Image Processing, Radiological
• NXQ: Reminder, Medication

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: 2023-10-02
• Device Publish Date: 2023-09-22

On-Brand Devices [icompanion]

• B621ICOMPANION103: 1
• B621ICOMPANION2X1Y0: 2.1
• B621ICOMPANION2X2Y0: 2.2