AI Devices

Emergency — AI devices

FDA-cleared and EU CE-marked radiology AI devices tagged Emergency, newest clearance first. Information only, never clinical advice.

EmergencyUS

JLK-NCCT

🇰🇷JLK, Inc.

Triage & notification (CADt)

Multi-modalityTriage & notification (CADt)510(k) 2026
EmergencyUS

Annalise Enterprise

🇦🇺Harrison-AI Medical Pty, Ltd.

Triage & notification (CADt)

Multi-modalityTriage & notification (CADt)510(k) 2026
EmergencyUS

BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device

🇮🇱Aidoc Medical , Ltd.

Triage & notification (CADt)

Multi-modalityTriage & notification (CADt)510(k) 2026
EmergencyUS

BriefCase-Triage

🇮🇱Aidoc Medical , Ltd.

Triage & notification (CADt)

Multi-modalityTriage & notification (CADt)510(k) 2026
EmergencyUS

BriefCase-Triage: CARE Multi-triage CT Body

🇮🇱Aidoc Medical , Ltd.

Triage & notification (CADt)

Multi-modalityTriage & notification (CADt)510(k) 2026
EmergencyUS

Scaida BrainCT-ICH (v1.0)

Mlhealth 360

Triage & notification (CADt)

Multi-modalityTriage & notification (CADt)510(k) 2025
EmergencyUS

a2z-Unified-Triage

A2z Radiology Ai, Inc.

Triage & notification (CADt)

Multi-modalityTriage & notification (CADt)510(k) 2025
EmergencyUS

BriefCase-Triage

🇮🇱Aidoc Medical , Ltd.

Triage & notification (CADt)

Multi-modalityTriage & notification (CADt)510(k) 2025
EmergencyUS

qER-CTA (v1.0)

🇮🇳Qure.Ai Technologies

Triage & notification (CADt)

Multi-modalityTriage & notification (CADt)510(k) 2025
EmergencyUS

Rapid Obstructive Hydrocephalus, Rapid OH

🇺🇸iSchemaView, Inc.

Triage & notification (CADt)

Multi-modalityTriage & notification (CADt)510(k) 2025
EmergencyUS

Brainomix 360 Triage Stroke

🇬🇧Brainomix Limited

Triage & notification (CADt)

Multi-modalityTriage & notification (CADt)510(k) 2025
EmergencyUS

Methinks CTA Stroke

Methinks Software S.L.

Triage & notification (CADt)

Multi-modalityTriage & notification (CADt)510(k) 2025
EmergencyUS

Rapid CTA 360

🇺🇸iSchemaView

Triage & notification (CADt)

Multi-modalityTriage & notification (CADt)510(k) 2025
EmergencyUS

Methinks NCCT Stroke

Methinks Software S.L.

Triage & notification (CADt)

Multi-modalityTriage & notification (CADt)510(k) 2025
EmergencyUS

BriefCase-Triage

🇮🇱Aidoc Medical , Ltd.

Triage & notification (CADt)

Multi-modalityTriage & notification (CADt)510(k) 2025
EmergencyUS

syngo.CT LVO Detection

🇺🇸Siemens Medical Solutions USA, Inc.

Triage & notification (CADt)

Multi-modalityTriage & notification (CADt)510(k) 2025
EmergencyUS

JLK-SDH

🇰🇷JLK, Inc.

Triage & notification (CADt)

Multi-modalityTriage & notification (CADt)510(k) 2025
EmergencyUS

EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100)

Ever Fortune.Ai, Co., Ltd.

Triage & notification (CADt)

Multi-modalityTriage & notification (CADt)510(k) 2025
EmergencyUS

BriefCase-Triage

🇮🇱Aidoc Medical , Ltd.

Triage & notification (CADt)

Multi-modalityTriage & notification (CADt)510(k) 2025
EmergencyUS

JLK-ICH

🇰🇷JLK, Inc.

Triage & notification (CADt)

Multi-modalityTriage & notification (CADt)510(k) 2025
EmergencyUS

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

Ever Fortune.Ai, Co., Ltd.

Triage & notification (CADt)

Multi-modalityTriage & notification (CADt)510(k) 2024
EmergencyUS

NeuroICH

🇺🇸Neurocareai Inc.

Triage & notification (CADt)

Multi-modalityTriage & notification (CADt)510(k) 2024
EmergencyUS

BriefCase-Triage

🇮🇱Aidoc Medical , Ltd.

Triage & notification (CADt)

Multi-modalityTriage & notification (CADt)510(k) 2024
EmergencyUS

JBS-LVO

🇰🇷JLK, Inc.

Triage & notification (CADt)

Multi-modalityTriage & notification (CADt)510(k) 2024
EmergencyUS

uAI Easy Triage ICH

Shanghai United Imaging Intelligence Co., Ltd.

Triage & notification (CADt)

Multi-modalityTriage & notification (CADt)510(k) 2024
EmergencyUS

CINA-CSpine

🇫🇷Avicenna.AI

Triage & notification (CADt)

Multi-modalityTriage & notification (CADt)510(k) 2024
EmergencyUS

BriefCase-Triage

🇮🇱Aidoc Medical , Ltd.

Triage & notification (CADt)

Multi-modalityTriage & notification (CADt)510(k) 2024
EmergencyUS

Hyper Insight - ICH

🇰🇷SK Inc.

Triage & notification (CADt)

Multi-modalityTriage & notification (CADt)510(k) 2024
EmergencyUS

Heuron ICH

🇰🇷Heuron Co., Ltd.

Triage & notification (CADt)

Multi-modalityTriage & notification (CADt)510(k) 2024
EmergencyUS

EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM

Ever Fortune.Ai, Co., Ltd.

Triage & notification (CADt)

Multi-modalityTriage & notification (CADt)510(k) 2024
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