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Vitrea Advanced Visualization

Canon Medical Informatics, Inc. · Model 7.8 · UDI-DI 00853866003360

JAK LLZ

510(k) clearances

5,280

Adverse events (219 deaths)

873

Recalls

166

Facilities

Description

The Vitrea Advanced Visualization software is a medical diagnostic system that allows the processing, review, analysis, communication, and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. The Vitrea Advanced Visualization system provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The Vitrea Advanced Visualization user interface follows typical clinical workflow patterns to process, review, and analyze digital images, including: • Retrieve image data over the network via DICOM • Display of images in dedicated protocols which are automatically adapted based on exam type • Select images for closer examination from a gallery of 2D or 3D views • Interactively manipulate an image in real-time to visualize anatomy and pathology • Annotate, measure, and record selected views • Output selected views to standard film or paper printers, or post a report to an intranet web server or export views to another DICOM device • Retrieve reports that are archived on a Web server

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.