BriefCase
Aidoc Medical, Ltd.BriefCase is an AI-based software by Aidoc Medical that helps radiologists and trained medical specialists detect and prioritize urgent cases from CT scans of various body regions including head, chest, abdomen, and cervical spine. It flags images with suspected critical findings like fractures, intracranial hemorrhage, pulmonary embolism, intra-abdominal free gas, and large vessel occlusion, presenting low-quality preview images and notifications to accelerate clinical workflow. The software works in parallel with standard of care and does not alter original medical images, serving as a triage and notification aid but not a diagnostic device.
Intended Use
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of CT images from multiple body regions to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communicating suspected positive findings of specific pathologies such as linear lucencies compatible with fractures (cervical spine CT), intracranial hemorrhage (non-enhanced head CT), pulmonary embolism (CTPA and chest CT), intra-abdominal free gas (abdominal CT), incidental pulmonary embolism (contrast-enhanced chest CT), and large vessel occlusion (head CTA).
Technology
BriefCase consists of AI algorithms running on a software platform comprised of three modules: Aidoc Hospital Server for image acquisition, Aidoc Cloud Server for image processing, and Aidoc Worklist Application on users' desktops for notification display. The software receives, processes, and analyzes DICOM images, sending notifications with low-quality preview images to users in parallel to the standard of care. It does not alter original images and includes features for filtering notifications by pathology or medical center.
Performance
No new performance data was required for this submission because the subject device is substantially equivalent to predicate devices cleared previously; initial clearance data described in prior 510(k)s support the safety and effectiveness of BriefCase.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/30/2020
29 days - 2
FDA Approval
12/29/2020
Other devices from Aidoc Medical, Ltd.
- BriefCase-Quantification2024 • 510K
- BriefCase-Triage2024 • 510K
- BriefCase-Triage2024 • 510K
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