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Anatomage Table

ANATOMAGE, INC. · Model 5.0.1 · UDI-DI 00852060007013

LLZ
1
510(k) clearances
19,970
Adverse events (41 deaths)
562
Recalls
638
Facilities

Description

Anatomage Table is a volumetric imaging software designed specifically for clinicians, doctors, physicians, and other qualified medical professionals. The software runs in Windows operating systems and visualizes medical imaging data on the computer screen. Users are to able examine anatomy on a computer screen and use software tools to move and manipulate rendered images by turning, zooming, flipping, adjusting contrast and brightness, cutting, and slicing using either a touch interface or standard mouse and keyboard interactions.

Recalls

DateFirmReason
2026-09-10INTELERAD MEDICAL SYSTEMS INCORPORATEDA cybersecurity vulnerability has been identified in the software that could allow a malicious user to take over an administrator session, delete or modify image or study data, or
2026-09-05INTELERAD MEDICAL SYSTEMS INCORPORATEDFollowing a Chromium-based web-browser, report and displayed images may not match.
2026-07-31GE HealthcareUnder 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
2026-07-31GE HealthcareUnder 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
2026-07-31GE HealthcareUnder 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
2026-07-31GE HealthcareUnder 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
2026-07-31GE HealthcareUnder 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
2026-07-31GE HealthcareUnder 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
2026-07-22Merge Healthcare, Inc.Software issue may cause measurements to be displayed inaccurately.
2026-07-22FUJIFILM Healthcare Americas CorporationSoftware issue may cause the ruler measurement to be inaccurate.

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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.