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 ID00850894007797
NIH Device Record Key9e8c45ed-c4e0-4e68-a71a-abd3189a8e93
Commercial Distribution StatusIn Commercial Distribution
Brand NameImbio CAC
Version Model Number2.0.0
Company DUNS078397649
Company NameImbio, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850894007797 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAKSystem, X-Ray, Tomography, Computed

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-27
Device Publish Date2023-07-19

Devices Manufactured by Imbio, LLC

00850894007889 - Imbio LDA2024-05-16 The Imbio CT Lung Density Analysis Software is a set of image post-processing algorithms that perform image segmentation, regist
00850894007735 - Imbio Freya2023-12-04 The Imbio CT Lung Density Analysis Software is a set of image post-processing algorithms that perform image segmentation, regist
00850894007865 - Imbio LDA2023-11-14 The Imbio CT Lung Density Analysis Software is a set of image post-processing algorithms that perform image segmentation, regist
00850894007841 - Imbio LDA2023-10-25 The Imbio CT Lung Density Analysis Software is a set of image post-processing algorithms that perform image segmentation, regist
00850894007858 - Imbio Freya2023-10-25 The Imbio CT Lung Density Analysis Software is a set of image post-processing algorithms that perform image segmentation, regist
00850894007810 - Imbio LDA2023-09-26 The Imbio CT Lung Density Analysis Software is a set of image post-processing algorithms that perform image segmentation, regist
00850894007827 - Imbio Freya2023-09-26 The Imbio CT Lung Density Analysis Software is a set of image post-processing algorithms that perform image segmentation, regist
00850894007797 - Imbio CAC2023-07-27Imbio’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.
00850894007797 - Imbio CAC2023-07-27 Imbio’s Coronary Artery Calcification (CAC) software is a set of automated image post-processing algorithms designed to help r
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