syngo.CT Brain Hemorrhage
Siemens Medical Solutions USA, Inc.syngo.CT Brain Hemorrhage is an AI-driven software that assists radiologists by analyzing non-contrast head CT scans to prioritize cases suspicious for acute intracranial hemorrhage. It flags findings to improve workflow efficiency by enabling faster review of urgent cases but is not intended for standalone diagnosis.
Intended Use
syngo.CT Brain Hemorrhage is designed to assist the radiologist in prioritizing cases of suspected intracranial hemorrhage on non-contrast CT examinations of the head. It makes case-level output available to a CT scanner or other PACS system for worklist prioritization. The output is intended for informational purposes only and is not intended for diagnostic use. The device does not alter the original medical image and is not intended to be used as a stand-alone diagnostic device.
Technology
syngo.CT Brain Hemorrhage is image processing software that uses artificial intelligence learning algorithms to analyze non-contrast head CT DICOM images, identifying findings suspicious for acute intracranial hemorrhage. It provides a processing pipeline and notification mechanism to flag findings for review, without altering original images.
Performance
Performance was validated in a retrospective standalone study with 600 anonymized head CT cases from 5 US and European sites, compared to ground truth by 3 expert neuroradiologists. Sensitivity was 92.8% and specificity was 94.5%, exceeding performance goals. Average processing time was 13.67 seconds per case, comparable to the predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/5/2020
1 year, 2 months - 2
FDA Approval
1/28/2022
Other devices from Siemens Medical Solutions USA, Inc.
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