IQ-UIP
Imbio, Inc.
IMBIO LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3011411323 | 3011411323 | IMBIO LLC | 1 | N | 2020-04-25 | 807 Broadway St NE, #350 Minneapolis MN US 55413 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 179333 | 1579179588 | K180129 | Imbio Segmentation Editing Tool software | LLZ | 2018-03-16 |
| 179333 | 1700458797 | K141069 | Lung Density Analysis | JAK | 2014-09-17 |
| 179333 | 1302531534 |
Product Codes Associated With Registrations#
PMN#
Imbio PHA (4.0.0)
Imbio, Inc.
CAC Software
Imbio, Inc.
Imbio RV/LV Software
Imbio, LLC
Imbio Segmentation Editing Tool Software
Imbio, LLC
Lung Density Analysis
IMBIO LLC
OCCLUSIN 500 ARTIFICIAL EMBOLIZATION DEVICE
IMBIOTECHNOLOGIES
GUDID#
Imbio PHA - The PHA Software is a set of medical image post-processing computer algorithms that together perform automated image segmentation and diameter measurements on computed tomography pulmonary angiography (CTPA) images. The device then reports the ratio of those diameter measurements. The PHA Software is a single command-line executable program that may be run directly from the command-line or through scripting and thus the user interface is minimal.
2025-04-21
Imbio LDA - 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.
2025-04-14
Imbio LDA - 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.
2025-02-11
Imbio LDA - 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.
2024-05-08
Imbio LDA - 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.
2019-01-07
Imbio LDA - 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.
2018-09-12
Imbio SET - Imbio Segmentation Editing Tool (SET) Software is a segmentation tool designedto allow users to optimize segmentations calculated by Imbio’s fully-automatedsuite of algorithms. Imbio is building a suite of medical image post-processing applicationsthat run automatically after data transfer off the medical imaging scanner.Automatic image segmentation is often an essential step in Imbio’s analyses.To date, the automatic segmentation algorithms used in Imbio’s applications havebeen robust, however segmentation failures do occur. The purpose of the SegmentationEditing Tool is to provide customers with a tool to locally correct poorsegmentations. Additionally, if the Imbio automatic segmentation fails such thatit is unable to produce a result, this tool can be used to semi-manually draw thesegmentation required for analysis.SET reads in anatomical images used in an automatic segmentation algorithmand the results of the automated segmentation algorithm (if available). The useris then able to locally correct insufficiencies in the segmentation result, or createa segmentation mask from scratch. The finalized segmentation mask is thenpushed back to Imbio’s Core Computing Platform and the job is re-processed.
2018-06-11
Imbio LDA - 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.
2017-10-02
Imbio LDA - 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.
2017-05-01
Imbio LDA - 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.
2017-04-04
Imbio LDA - 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.
2017-01-13
Imbio LDA - 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.
2016-09-27
Imbio LDA - 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.
2016-09-27
Imbio SET - Imbio Segmentation Editing Tool (SET) Software is a segmentation tool designedto allow users to optimize segmentations calculated by Imbio’s fully-automatedsuite of algorithms. Imbio is building a suite of medical image post-processing applicationsthat run automatically after data transfer off the medical imaging scanner.Automatic image segmentation is often an essential step in Imbio’s analyses.To date, the automatic segmentation algorithms used in Imbio’s applications havebeen robust, however segmentation failures do occur. The purpose of the SegmentationEditing Tool is to provide customers with a tool to locally correct poorsegmentations. Additionally, if the Imbio automatic segmentation fails such thatit is unable to produce a result, this tool can be used to semi-manually draw thesegmentation required for analysis.SET reads in anatomical images used in an automatic segmentation algorithmand the results of the automated segmentation algorithm (if available). The useris then able to locally correct insufficiencies in the segmentation result, or createa segmentation mask from scratch. The finalized segmentation mask is thenpushed back to Imbio’s Core Computing Platform and the job is re-processed.
2019-09-25
Imbio LDA - 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.
2019-09-25
Imbio LDA - 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.
2019-10-17
Imbio LDA - 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.
2020-08-05
Imbio LDA - 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.
2020-11-23
Imbio LDA - 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.
2021-01-27
Imbio LDA - 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.
2021-03-29
Imbio LDA - 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.
2021-05-25
Imbio LDA - 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.
2021-09-10
Imbio Freya - 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.
2022-02-01
Imbio Freya - 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.
2022-04-25
Imbio LDA - 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.
2022-09-06
Imbio SET - Imbio Segmentation Editing Tool (SET) Software is a segmentation tool designedto allow users to optimize segmentations calculated by Imbio’s fully-automatedsuite of algorithms. Imbio is building a suite of medical image post-processing applicationsthat run automatically after data transfer off the medical imaging scanner.Automatic image segmentation is often an essential step in Imbio’s analyses.To date, the automatic segmentation algorithms used in Imbio’s applications havebeen robust, however segmentation failures do occur. The purpose of the SegmentationEditing Tool is to provide customers with a tool to locally correct poorsegmentations. Additionally, if the Imbio automatic segmentation fails such thatit is unable to produce a result, this tool can be used to semi-manually draw thesegmentation required for analysis.SET reads in anatomical images used in an automatic segmentation algorithmand the results of the automated segmentation algorithm (if available). The useris then able to locally correct insufficiencies in the segmentation result, or createa segmentation mask from scratch. The finalized segmentation mask is thenpushed back to Imbio’s Core Computing Platform and the job is re-processed.
2023-06-07
Imbio Freya - 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.
2023-07-12
Imbio LDA - 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.
2023-07-12
Imbio CAC - 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.
2023-07-19
Imbio Freya - 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.
2023-09-18
Imbio LDA - 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.
2023-09-18
Imbio Freya - 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.
2023-10-17
Imbio LDA - 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.
2023-10-17
Imbio LDA - 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.
2023-11-06
Imbio Freya - 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.
2023-01-24
Imbio RV/LV - The Imbio CT RV/LV Software is a set of medical image post-processing computer algorithms that together perform automated image segmentation and diameter measurements on computed tomography pulmonary angiography (CTPA) images. The device then reports the ratio of those diameter measurements. The Imbio CT RV/LV Software is a single command-line executable program that may be run directly from the command-line or through scripting and thus the user interface is minimal.
2023-04-28
Imbio RV/LV - The Imbio CT RV/LV Software is a set of medical image post-processing computer algorithms that together perform automated image segmentation and diameter measurements on computed tomography pulmonary angiography (CTPA) images. The device then reports the ratio of those diameter measurements. The Imbio CT RV/LV Software is a single command-line executable program that may be run directly from the command-line or through scripting and thus the user interface is minimal.
2023-02-22
Imbio RV/LV - The Imbio CT RV/LV Software is a set of medical image post-processing computer algorithms that together perform automated image segmentation and diameter measurements on computed tomography pulmonary angiography (CTPA) images. The device then reports the ratio of those diameter measurements. The Imbio CT RV/LV Software is a single command-line executable program that may be run directly from the command-line or through scripting and thus the user interface is minimal.
2021-12-09
Imbio RV/LV - The Imbio CT RV/LV Software is a set of medical image post-processing computer algorithms that together perform automated image segmentation and diameter measurements on computed tomography pulmonary angiography (CTPA) images. The device then reports the ratio of those diameter measurements. The Imbio CT RV/LV Software is a single command-line executable program that may be run directly from the command-line or through scripting and thus the user interface is minimal.
2021-08-10
Imbio RV/LV - The Imbio CT RV/LV Software is a set of medical image post-processing computer algorithms that together perform automated image segmentation and diameter measurements on computed tomography pulmonary angiography (CTPA) images. The device then reports the ratio of those diameter measurements. The Imbio CT RV/LV Software is a single command-line executable program that may be run directly from the command-line or through scripting and thus the user interface is minimal.
2021-04-05