Radiology · 510(k) · 2024
EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100)
Ever Fortune.AI, Co., Ltd.. Cleared by FDA on 6 December 2024 under submission K241923, product code QAS (radiological computer-assisted triage and notification software). What FDA's record says, in FDA's words.
Device record · K241923
- Device. EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100)DEVICE
- Company. Ever Fortune.AI, Co., Ltd. (TW)COMPANY
- Decision. 6 December 2024, 510(k), substantially equivalent (traditional review); received 1 July 2024DECISION
- Panel. RadiologyPANEL
- Product code. QAS, Radiological Computer-Assisted Triage And Notification SoftwareCODE
- Regulation. 21 CFR 892.2080, Class IIREG
- Source. FDA database entry · decision document (10 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
EFAI NEUROSUITE CT MIDLINE SHIFT ASSESSMENT SYSTEM (EFAI MLSCT) is a software workflow tool designed to aid in prioritizing the clinical assessment of non-contrast head CT cases with features suggestive of midline shift (MLS) in individuals aged 18 years and above. EFAI MLSCT analyzes cases using deep learning algorithms to identify suspected MLS findings. It makes case-level output available to a PACS/workstation for worklist prioritization or triage. EFAI MLSCT is not intended to direct attention to specific portions of an image or to anomalies other than MLS. Its results are not intended to be used on a stand-alone basis for clinical decision-making nor is it intended to rule out MLS or otherwise preclude clinical assessment of CT studies.
The product code's definition, from FDA's classification record. Radiological computer-assisted triage and notification software is an image processing device intended to aid in prioritization and triage of time sensitive patient detection and diagnosis based on the analysis of medical images acquired from radiological signal acquisition systems. The device identifies or prioritizes time sensitive imaging for review by prespecified clinical users based on software-based image analysis but does not provide information from the image analysis other than triage and notification .
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedCT
- Mentionstriage or notification
- Mentionsdetection or identification of findings
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code QAS. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code QAS, in Radiology, from Ever Fortune.AI, Co., Ltd., or cleared in 2024. The whole record is at FDA AI-enabled medical devices.
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