Imbio SET

GUDID 00850894007759

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.

Imbio, LLC

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• Primary Device ID: 00850894007759
• NIH Device Record Key: 40bf51e7-53b2-4563-a561-cad12ae8689a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Imbio SET
• Version Model Number: 1.0.3.5
• Company DUNS: 078397649
• Company Name: Imbio, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850894007759 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180129

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-15
• Device Publish Date: 2023-06-07

On-Brand Devices [Imbio SET]

• 00850894007209: Imbio Segmentation Editing Tool (SET) Software is a segmentation tool designed to allow users to
• 00850894007445: Imbio Segmentation Editing Tool (SET) Software is a segmentation tool designed to allow users to
• 00850894007759: Imbio Segmentation Editing Tool (SET) Software is a segmentation tool designed to allow users to