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Vitrea

Canon Medical Informatics, Inc. · Model 6.9.1 · UDI-DI 00853866003247

LLZ JAK

510(k) clearances

19,695

Adverse events (41 deaths)

560

Recalls

632

Facilities

Description

Vitrea® is a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of digital images acquired from a variety of imaging devices. Vitrea is not meant for primary image interpretation in mammography. Vitrea provides visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The Vitrea user interface follows typical clinical workflow patterns to process, review, and analyze digital images. It is a web-based imaging system that allows physicians to use PCs or notebook computers to remotely access to 2D and 3D advanced visualization using a Microsoft web-enabled browser. Vitrea modules include automated and semi-automated visualization and advanced quantification tools targeted for a specific study based on a protocol selected by the user. The automation is only intended to reduce the manual steps required by the user to analyze and quantify the data from the images; it is not intended to detect pathology or disease. The software provides imaging information as an assist to the physician.

Recalls

Date	Firm	Reason
2026-07-31	GE Healthcare	Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be
2026-07-31	GE Healthcare	Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be
2026-07-31	GE Healthcare	Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be
2026-07-31	GE Healthcare	Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be
2026-07-31	GE Healthcare	Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be
2026-07-31	GE Healthcare	Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be
2026-07-22	FUJIFILM Healthcare Americas Corporation	Software issue may cause the ruler measurement to be inaccurate.
2026-07-22	Merge Healthcare, Inc.	Software issue may cause measurements to be displayed inaccurately.
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

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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.