DEVICE: Imbio SET (00850894007209)
Device Identifier (DI) Information
Imbio SET
1.0.3.2
In Commercial Distribution
Imbio, LLC
1.0.3.2
In Commercial Distribution
Imbio, LLC
Imbio Segmentation Editing Tool (SET) Software is a segmentation tool designed
to allow users to optimize segmentations calculated by Imbio’s fully-automated
suite of algorithms. Imbio is building a suite of medical image post-processing applications
that 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 have
been robust, however segmentation failures do occur. The purpose of the Segmentation
Editing Tool is to provide customers with a tool to locally correct poor
segmentations. Additionally, if the Imbio automatic segmentation fails such that
it is unable to produce a result, this tool can be used to semi-manually draw the
segmentation required for analysis.
SET reads in anatomical images used in an automatic segmentation algorithm
and the results of the automated segmentation algorithm (if available). The user
is then able to locally correct insufficiencies in the segmentation result, or create
a segmentation mask from scratch. The finalized segmentation mask is then
pushed back to Imbio’s Core Computing Platform and the job is re-processed.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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57812 | Radiology DICOM image processing application software |
A software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/disc burning) and/or image quality manipulation and quantification (e.g., non-interpretive graphical overlays).
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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LLZ | System, Image Processing, Radiological |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K180129 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
448d7ef5-402a-497f-bba0-78fdd30d5f7d
December 04, 2023
4
June 11, 2018
December 04, 2023
4
June 11, 2018
Alternative and Additional Identifiers Additional Identifiers
Package DI
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined