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.
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
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)
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Device labeled as "Not made with natural rubber latex"
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For Single-Use
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Prescription Use (Rx)
-
Over the Counter (OTC)
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Kit
-
Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
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FDA Premarket Submission
K180129
Product Code
LLZ
Product Code Name
System, Image Processing, Radiological
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
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 24 |