Imbio SET - Imbio Segmentation Editing Tool (SET) Software is - Imbio, LLC

Duns Number:078397649

Device Description: Imbio Segmentation Editing Tool (SET) Software is a segmentation tool designedto allow use 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.

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More Product Details

Catalog Number

-

Brand Name

Imbio SET

Version/Model Number

1.0.3.2

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K180129

Product Code Details

Product Code

LLZ

Product Code Name

System, Image Processing, Radiological

Device Record Status

Public Device Record Key

448d7ef5-402a-497f-bba0-78fdd30d5f7d

Public Version Date

October 07, 2019

Public Version Number

3

DI Record Publish Date

June 11, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"IMBIO, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 24