DEVICE: Imbio SET (00850894007445)

Device Identifier (DI) Information

Imbio SET
1.0.3.3
In Commercial Distribution

Imbio, LLC
00850894007445
GS1

1
078397649 *Terms of Use
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
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Yes
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GMDN

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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?
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).
Active false
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FDA Product Code

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Product Code Product Code Name
LLZ System, Image Processing, Radiological
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K180129 000
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Sterilization

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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

3d3c1c65-da13-494f-b2f4-cea206932379
December 04, 2023
3
September 25, 2019
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
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None
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Production Identifier(s) in UDI

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No
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Yes
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Customer Contact

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No Customer Contact currently defined
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