Imbio Segmentation Editing Tool Software
by Imbio, LLC
510(k) K180129
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK180129 | Date16 Mar 2018 | StatusActive |
Official records
- FDA 510(k) database K180129
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LLZ
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
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.
Devices cleared under K180129
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Imbio SET 1.0.3.2 | 1.0.3.2 | 00850894007209 | On the market | |
| Imbio SET 1.0.3.3 | 1.0.3.3 | 00850894007445 | On the market | |
| Imbio SET 1.0.3.5 | 1.0.3.5 | 00850894007759 | On the market |
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