Imbio CAC

GUDID 00850894007797

Imbio’s Coronary Artery Calcification (CAC) software is a set of automated image post-processing algorithms designed to help radiologists and cardiologists determine the location and calculate the amount of calcification within the coronary arteries in patients who have undergone a non- contrast, chest computed tomography (CT), by providing visualization and quantification of abnormal coronary CT densities. The Imbio CAC software runs automatically on the input CT series, with no user input or intervention. The Imbio CAC software analyses high resolution CT DICOM images of the heart. The Imbio CAC algorithm provides a DICOM or PDF summary report with the results of the analysis.

Imbio, LLC

Radiology DICOM image processing application software

• Primary Device ID: 00850894007797
• NIH Device Record Key: 9e8c45ed-c4e0-4e68-a71a-abd3189a8e93
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Imbio CAC
• Version Model Number: 2.0.0
• 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	00850894007797 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230112

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: 2023-07-27
• Device Publish Date: 2023-07-19

Devices Manufactured by Imbio, LLC

• 00850894007902 - Imbio PHA: 2025-04-29 The PHA Software is a set of medical image post-processing computer algorithms that together perform automated image segmentatio
• 00850894007926 - Imbio LDA: 2025-04-22 The Imbio CT Lung Density Analysis Software is a set of image post-processing algorithms that perform image segmentation, regist
• 00850894007933 - Imbio LDA: 2025-02-19 The Imbio CT Lung Density Analysis Software is a set of image post-processing algorithms that perform image segmentation, regist
• 00850894007889 - Imbio LDA: 2024-05-16 The Imbio CT Lung Density Analysis Software is a set of image post-processing algorithms that perform image segmentation, regist
• 00850894007735 - Imbio Freya: 2023-12-04 The Imbio CT Lung Density Analysis Software is a set of image post-processing algorithms that perform image segmentation, regist
• 00850894007865 - Imbio LDA: 2023-11-14 The Imbio CT Lung Density Analysis Software is a set of image post-processing algorithms that perform image segmentation, regist
• 00850894007841 - Imbio LDA: 2023-10-25 The Imbio CT Lung Density Analysis Software is a set of image post-processing algorithms that perform image segmentation, regist
• 00850894007858 - Imbio Freya: 2023-10-25 The Imbio CT Lung Density Analysis Software is a set of image post-processing algorithms that perform image segmentation, regist