The device detects intracranial hemorrhage (ICH), or brain bleeding, in adult non-contrast head computed tomography.
Accipio Ix, which received the CE Mark earlier in the year, uses AI algorithms to identify and mark potential regions of interest related to acute ICH.
Accipiolx is a software workflow tool designed to aid in prioritizing the clinical assessment of adult non-contrast heat CT cases with features suggestive of acute intracranial hemorrhage in the acute care environment. Accipiolx analyzes cases using an artificial intelligence algorithm to identify suspected findings. It makes case-level output available to a PACS workstation for wordlist prioritization or triage.
Accipiolx is not intended to direct attention to specific portions of an image or to anomalies other than acute intracranial hemorrhage. Its results are not intended to be used on a stand-alone basis for clinical decision-making nor is it intended to rule out hemorrhage or otherwise preclude clinical assessment of CT cases.
Source: FDA 510(k) clearance letter
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