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Imbio SET

FDA UDI

Class II (US FDA UDI)

by Imbio, LLC

Identity

Trade Name
Imbio SET FDA UDI
Generic Name
Radiology DICOM image processing application software FDA UDI
Device Name
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. FDA UDI
Model / Reference
1.0.3.3 FDA UDI
Description
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. FDA UDI

Identifiers

Primary DI / UDI-DI
00850894007445 FDA UDI
510(k) Number
K180129 FDA UDI
FDA Product Code
LLZ FDA UDI
GMDN Term
Radiology DICOM image processing application software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.2050 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Radiology DICOM image processing application software

Imbio SET by Imbio, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radiology DICOM image processing application software.

Cleared under the same submission

K180129 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Imbio, LLC

Sources (1)

  • FDA UDI 3d3c1c65-da13-494f-b2f4-cea206932379 34 fields · synced Jun 8, 2026