Imbio Segmentation Editing Tool Software
FDA 510(k)Class II (US FDA 510(k))
by Imbio, LLC
Identifiers
- 510(k) Number
- K180129 FDA 510(k)
- FDA Product Code
- LLZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2050 FDA 510(k)
- Regulation Number
- 892.2050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Imbio Segmentation Editing Tool Software is a medical image post-processing application designed for manual refinement of segmentation masks. It enables trained medical professionals to correct errors or incomplete delineations generated by automated segmentation algorithms, ensuring accurate anatomical or pathological region identification in medical imaging studies.
This web-based tool is intended for use by radiologists, oncologists, and medical imaging technologists to locally edit segmentation outputs. Supplied as a standalone software solution, it operates post-acquisition on imaging data transferred from scanners. The device holds FDA 510(k) clearance (K180129) under the Radiology Advisory Committee, classified under product code LLZ, and is not classified as a reusable or single-use device. No sterility or MRI safety specifications are stated.
Frequently asked questions
What is the primary purpose of the Imbio Segmentation Editing Tool software, and who is it intended for?
The Imbio Segmentation Editing Tool software is designed to manually refine segmentation masks created by automated algorithms in medical imaging. It helps radiologists, oncologists, and medical imaging technologists correct errors or incomplete delineations to ensure precise identification of anatomical or pathological regions. This tool operates as a standalone, web-based application post-acquisition, meaning it works on imaging data already transferred from scanners for further editing.
How is the Imbio Segmentation Editing Tool software supplied, and is it reusable or single-use?
The software is supplied as a standalone, web-based solution and is not classified as either reusable or single-use. Since it is a digital tool, it does not require physical handling or disposal like traditional medical devices, and its use is repeated across different imaging studies as needed by trained professionals.
Does the Imbio Segmentation Editing Tool software require any special storage conditions, and is it sterile?
The software does not require any special storage conditions as it is a digital, web-based tool. Additionally, since it is not a physical device, it is not sterile or subject to sterility requirements. Proper storage only involves maintaining access to the software platform and ensuring system compatibility for use.
What regulatory pathway was followed for the FDA clearance of the Imbio Segmentation Editing Tool software?
The Imbio Segmentation Editing Tool software received FDA clearance through a traditional 510(k) process, specifically under the Radiology Advisory Committee (RA). It was classified under product code LLZ and determined to be substantially equivalent to a predicate device. The clearance was granted on March 16, 2018, following a review by Imbio, LLC.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF SEGMENTATIONEDITINGTOOL S - imbio.com, Imbio Segmentation Editing Tool software (K180129) — FDA 510 (k ..., PDF SEGMENTATIONEDITINGTOOL
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K180129 | Class II | Active |
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Manufacturer
- Manufacturer
- Imbio, LLC
Sources (1)
- FDA 510(k) K180129 24 fields · synced Sep 20, 2026