Search Results
Found 1 results
510(k) Data Aggregation
K Number
K241719Device Name
NeuroICH
Manufacturer
Neurocareai Inc.
Date Cleared
2024-11-07
(146 days)
Product Code
QAS
Regulation Number
892.2080Why did this record match?
Applicant Name (Manufacturer) :
Neurocareai Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
NeuroICH is a notification-only, parallel workflow tool for use by hospital networks and trained clinicians to identify and communicate images of suspected ICH patients to a specialist, independent of standard of care workflow.
The device uses an artificial intelligence algorithm to analyze non-contrast CT images of the head acquired in the acute setting for findings suggestive of intracranial hemorrhage (ICH) in parallel to the ongoing standard of care image interpretation and notify an appropriate clinician of these findings. Notifications include non-diagnostic preview images that are meant for informational purposes only. The device does not alter or remove the original medical image and is not intended to be used as a diagnostic device. Images can be previewed through a mobile application.
Notified clinicians are responsible for viewing high quality images on a diagnostic viewer per the standard of care and engaging in appropriate patient evaluation in conjunction with other patient information before making care-related decisions. NeuroICH is limited to analysis of imaging data and should not be used in-lieu of full patient evaluation or relied upon to make or confirm diagnosis.
Device Description
NeurolCH is a software-only parallel workflow tool designed for use by hospital networks and trained clinicians to identify and communicate prioritized images of specific patients to an appropriate specialist such as neurovascular or neurosurgical specialist independent of the standard of care workflow. NeuroICH mainly consists of an image analysis module hosted on cloud, and a mobile application for preview of notification and non-diagnostic images. The standalone software device automatically receives and analyzes non-contrast head CT (NCCT) studies of patients undergoing stroke protocol, for image features that indicate the presence of an intracranial hemorrhage (ICH) using deep learning artificial intelligence algorithm, and upon detection of a suspected ICH case, sends a notification along with non-diagnostic image on mobile application to alert a specialist clinician.
Ask a Question
Page 1 of 1