# K241923: EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100)

- Pathway: 510(k) (Traditional)
- Applicant: Ever Fortune.Ai, Co., Ltd.
- Decided: Dec 6, 2024 after 158 days
- Product code: QAS (Radiological Computer-Assisted Triage And Notification Software)
- Device class: 2
- Regulation: 21 CFR 892.2080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to DEN170073 (2018). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200921: qER, Qure.Ai Technologies (2020) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K241923
Methodology: https://510kreport.com/methodology