Imbio Freya

GUDID 00850894007827

The Imbio CT Lung Density Analysis Software is a set of image post-processing algorithms that perform image segmentation, registration, thresholding, and classification on CT images of human lungs. Imbio CT Lung Density Analysis Software is a command-line software application that analyzes DICOM CT lung image datasets and generates reports and DICOM output that show the lungs segmented and overlaid with color-codings representing the results of its thresholding and classification rules. It has simple file management functions for input and output. Imbio CT Lung Density Analysis Software does not interface directly with any CT or data collection equipment; instead the software imports data files previously generated by such equipment.

Imbio, LLC

Radiology DICOM image processing application software

• Primary Device ID: 00850894007827
• NIH Device Record Key: a2e52ba4-0dce-49f1-9b90-1cfc6405fa5f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Imbio Freya
• Version Model Number: 5.0.1
• Company DUNS: 078397649
• Company Name: Imbio, LLC
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850894007827 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141069

FDA Product Code

• JAK: System, X-Ray, Tomography, Computed

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: 2023-09-26
• Device Publish Date: 2023-09-18

On-Brand Devices [Imbio Freya]

• 00850894007667: The Imbio CT Lung Density Analysis Software is a set of image post-processing algorithms that pe
• 00850894007681: The Imbio CT Lung Density Analysis Software is a set of image post-processing algorithms that pe
• 00850894007780: The Imbio CT Lung Density Analysis Software is a set of image post-processing algorithms that pe
• 00850894007827: The Imbio CT Lung Density Analysis Software is a set of image post-processing algorithms that pe
• 00850894007858: The Imbio CT Lung Density Analysis Software is a set of image post-processing algorithms that pe
• 00850894007735: The Imbio CT Lung Density Analysis Software is a set of image post-processing algorithms that pe