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Imbio LDA

Imbio, LLC · Model 2.5.1 · UDI-DI 00850894007292

JAK

510(k) clearances

5,267

Adverse events (219 deaths)

873

Recalls

164

Facilities

Description

The Imbio CT Lung Density Analysis Software is a set of image post-processing algorithms that perform image segmentation, registration, thresholding, and classification on CT images of human lungs. Imbio CT Lung Density Analysis Software is a command-line software application that analyzes DICOM CT lung image datasets and generates reports and DICOM output that show the lungs segmented and overlaid with color-codings representing the results of its thresholding and classification rules. It has simple file management functions for input and output. Imbio CT Lung Density Analysis Software does not interface directly with any CT or data collection equipment; instead the software imports data files previously generated by such equipment.

Recalls

Date	Firm	Reason
2026-08-21	PHILIPS MEDICAL SYSTEMS	Software issues may affect the safety and performance of Spectral CT system(s). The issues may result in image artifacts, wrong slice thickness, or unintended system motion.
2026-08-18	Philips North America Llc	The Bolus tracking scan application may crash with a system error message. Bolus Tracker shots may continue to occur even if the contrast threshold is reached. This may result in t
2026-08-11	Shanghai United Imaging Healthcare Co., Ltd.	Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single
2026-08-11	Shanghai United Imaging Healthcare Co., Ltd.	Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single
2026-08-11	Shanghai United Imaging Healthcare Co., Ltd.	Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single
2026-08-11	Shanghai United Imaging Healthcare Co., Ltd.	Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single
2026-08-11	Shanghai United Imaging Healthcare Co., Ltd.	Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single
2026-08-11	Shanghai United Imaging Healthcare Co., Ltd.	Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single
2026-08-07	Philips North America Llc	Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment.
2026-08-07	Philips North America Llc	Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment.

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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.