Imbio SET
- Primary DI
- 00850894007759
- Brand
- Imbio SET
- Company
- Imbio, LLC
- Model
- 1.0.3.5
- Device description
- Imbio Segmentation Editing Tool (SET) Software is a segmentation tool designedto allow users to optimize segmentations calculated by Imbio’s fully-automatedsuite of algorithms. Imbio is building a suite of medical image post-processing applicationsthat 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 havebeen robust, however segmentation failures do occur. The purpose of the SegmentationEditing Tool is to provide customers with a tool to locally correct poorsegmentations. Additionally, if the Imbio automatic segmentation fails such thatit is unable to produce a result, this tool can be used to semi-manually draw thesegmentation required for analysis.SET reads in anatomical images used in an automatic segmentation algorithmand the results of the automated segmentation algorithm (if available). The useris then able to locally correct insufficiencies in the segmentation result, or createa segmentation mask from scratch. The finalized segmentation mask is thenpushed back to Imbio’s Core Computing Platform and the job is re-processed.
- Published
- 2023-06-07
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
Product Codes#
| Code | Name |
|---|---|
| LLZ | System, Image Processing, Radiological |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | Radiology | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K180129 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00850894007759 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00850894007759 | 00850894007759 | 850894007759 | 0850894007759 |
GMDN Terms#
| Term | Definition |
|---|---|
| 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 manipulation and quantification (e.g., non-interpretive graphical overlays). |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 078397649
- Device count
- 1
- Manufacturing date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00850894007902 | Imbio PHA | 4.0.0 | 2025-04-21 | |
| 00850894007926 | Imbio LDA | 5.1.1 | 2025-04-14 | |
| 00850894007933 | Imbio LDA | 5.1.1 | 2025-02-11 | |
| 00850894007889 | Imbio LDA | 5.1.0 | 2024-05-08 | |
| 00850894007735 | Imbio Freya | 4.0.1 | 2023-01-24 | |
| 00850894007865 | Imbio LDA | 5.0.3 | 2023-11-06 | |
| 00850894007841 | Imbio LDA | 5.0.2 | 2023-10-17 | |
| 00850894007858 | Imbio Freya | 5.0.2 | 2023-10-17 | |
| 00850894007810 | Imbio LDA | 5.0.1 | 2023-09-18 | |
| 00850894007827 | Imbio Freya | 5.0.1 | 2023-09-18 | |
| 00850894007797 | Imbio CAC | 2.0.0 | 2023-07-19 | |
| 00850894007773 | Imbio LDA | 5.0.0 | 2023-07-12 | |
| 00850894007780 | Imbio Freya | 5.0.0 | 2023-07-12 | |
| 00850894007674 | Imbio LDA | 4.1.0 | 2022-09-06 | |
| 00850894007681 | Imbio Freya | 3.3.0 | 2022-04-25 | |
| 00850894007667 | Imbio Freya | 3.2.0 | 2022-02-01 | |
| 00850894007629 | Imbio LDA | 4.0.0 | 2021-09-10 | |
| 00850894007612 | Imbio LDA | 3.1.1 | 2021-05-25 | |
| 00850894007599 | Imbio LDA | 3.1 | 2021-03-29 | |
| 00850894007582 | Imbio LDA | 3.0.3 | 2021-01-27 |
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