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Imbio SET

Imbio, LLC · Model 1.0.3.3 · UDI-DI 00850894007445

LLZ Prescription

510(k) clearances

19,695

Adverse events (41 deaths)

554

Recalls

633

Facilities

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.

Recalls

Date	Firm	Reason
2026-07-22	Merge Healthcare, Inc.	Software issue may cause measurements to be displayed inaccurately.
2026-07-22	FUJIFILM Healthcare Americas Corporation	Software issue may cause the ruler measurement to be inaccurate.
2026-06-30	Merge Healthcare, Inc.	Merge Healthcare has identified a potential issue that may cause thumbnails from a previously opened patient study to be displayed in the Thumbnail Bar while a different patient st
2026-06-30	Merge Healthcare, Inc.	Merge Healthcare has identified a potential issue that may cause thumbnails from a previously opened patient study to be displayed in the Thumbnail Bar while a different patient st
2026-06-19	Boston Scientific Corporation	Software anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the Activity Calculator to modify one or more input. When a user modifies an inpu
2026-05-08	GE Medical Systems SCS	GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When a user selects a patient or exam in the AW Server Web Client worklist and launches
2026-03-19	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	Potential safety issue involving the Mean Aneurysm Flow Amplitude (MAFA) ratio of AneurysmFlow (Interventional Tool). Philips has determined that the MAFA ratio does not provide re
2026-03-05	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display out of sequence.
2026-01-30	GE Medical Systems, LLC	There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, w
2026-01-30	GE Medical Systems, LLC	There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, w

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.