86 devices · 38 companies · 2018 to 2026
Product code QAS: Radiological Computer-Assisted Triage And Notification Software
86 devices under product code QAS, 2018 to 2026, from 38 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (85 of 86 here), the regulation, and MAUDE report counts by product code.
Radiological Computer-Assisted Triage And Notification Software. 21 CFR 892.2080, Class II. 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 . MAUDE held 0 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Companies with more than one device here
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| Vascular Assist Occlusion TriageK260729 · 510(k) | GuideAI Health | Radiology | database entry | |
| BriefCase-TriageK261317 · 510(k) | Aidoc Medical , Ltd. | Radiology | database entry | |
| EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEMK253163 · 510(k) | Ever Fortune.Ai, Co., Ltd. | Radiology | database entry | |
| JLK-NCCTK252421 · 510(k) | JLK, Inc. | Radiology | database entry | |
| Annalise EnterpriseK253818 · 510(k) | Harrison-AI Medical Pty, Ltd. | Radiology | database entry | |
| BriefCase-Triage: CARE Multi-Triage CT for PneumK253578 · 510(k) | Aidoc Medical , Ltd. | Radiology | database entry | |
| BriefCase-TriageK251195 · 510(k) | Aidoc Medical , Ltd. | Radiology | database entry | |
| BriefCase-Triage: CARE Multi-triage CT BodyK252970 · 510(k) | Aidoc Medical , Ltd. | Radiology | database entry | |
| Scaida BrainCT-ICHK250694 · 510(k) | Mlhealth 360 | Radiology | database entry | |
| a2z-Unified-TriageK252366 · 510(k) | A2z Radiology Ai, Inc. | Radiology | database entry | |
| BriefCase-TriageK253265 · 510(k) | Aidoc Medical , Ltd. | Radiology | database entry | |
| qER-CTAK251610 · 510(k) | Qure.ai Technologies | Radiology | database entry | |
| Rapid Obstructive Hydrocephalus, Rapid OHK251533 · 510(k) | iSchemaView Inc. | Radiology | database entry | |
| Brainomix 360 Triage StrokeK251983 · 510(k) | Brainomix Limited | Radiology | database entry | |
| Methinks CTA StrokeK251590 · 510(k) | Methinks Software S.L. | Radiology | database entry | |
| Rapid CTA 360K251151 · 510(k) | iSchemaView | Radiology | database entry | |
| Methinks NCCT StrokeK250685 · 510(k) | Methinks Software S.L. | Radiology | database entry | |
| BriefCase-TriageK251406 · 510(k) | Aidoc Medical, Ltd. | Radiology | database entry | |
| syngo.CT LVO DetectionK243145 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | database entry | |
| JLK-SDHK243611 · 510(k) | JLK, Inc. | Radiology | database entry | |
| EFAI Chestsuite XR Malpositioned ETT AssessmentK242821 · 510(k) | Ever Fortune.AI, Co., Ltd. | Radiology | database entry | |
| BriefCase-TriageK250248 · 510(k) | Aidoc Medical, Ltd. | Radiology | database entry | |
| JLK-ICHK243363 · 510(k) | JLK, Inc. | Radiology | database entry | |
| EFAI Neurosuite CT Midline Shift Assessment SystK241923 · 510(k) | Ever Fortune.AI, Co., Ltd. | Radiology | database entry | |
| NeuroICHK241719 · 510(k) | Neurocareai Inc. | Radiology | database entry | |
| BriefCase-TriageK242837 · 510(k) | Aidoc Medical, Ltd. | Radiology | database entry | |
| JBS-LVOK241480 · 510(k) | JLK, Inc. | Radiology | database entry | |
| uAI Easy Triage ICHK242292 · 510(k) | Shanghai United Imaging Intelligence Co., Ltd. | Radiology | database entry | |
| CINA-CSpineK240942 · 510(k) | Avicenna.AI | Radiology | database entry | |
| BriefCase-TriageK241727 · 510(k) | Aidoc Medical, Ltd. | Radiology | database entry | |
| Hyper Insight - ICHK240353 · 510(k) | SK Inc. | Radiology | database entry | |
| Heuron ICHK233247 · 510(k) | Heuron Co., Ltd. | Radiology | database entry | |
| EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESK240291 · 510(k) | Ever Fortune.AI, Co., Ltd. | Radiology | database entry | |
| syngo.CT Brain HemorrhageK232431 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | database entry | |
| CINA-iPEK233968 · 510(k) | Avicenna.AI | Radiology | database entry | |
| Brainomix 360 Triage StrokeK232496 · 510(k) | Brainomix Limited | Radiology | database entry | |
| BriefCase-TriageK232751 · 510(k) | Aidoc Medical, Ltd. | Radiology | database entry | |
| Rapid SDHK232436 · 510(k) | iSchemaView, Inc. | Radiology | database entry | |
| EFAI NeuroSuite CT ICH Assessment SystemK231025 · 510(k) | Ever Fortune.AI Co., Ltd. | Radiology | database entry | |
| Brainomix 360 Triage LVOK231837 · 510(k) | Brainomix Limited | Radiology | database entry | |
| Annalise Enterprise CTB Triage TraumaK231767 · 510(k) | Annalise-AI Pty Ltd | Radiology | database entry | |
| Annalise Enterprise CTB Triage TraumaK231384 · 510(k) | Annalise-AI Pty Ltd. | Radiology | database entry | |
| Annalise Enterprise CTB Triage-OHK231094 · 510(k) | Annalise-AI Pty Ltd | Radiology | database entry | |
| Brainomix 360 Triage ICHK231195 · 510(k) | Brainomix Limited | Radiology | database entry | |
| Annalise Enterprise CTB Triage TraumaK223240 · 510(k) | Annalise-AI Pty Ltd | Radiology | database entry | |
| Rapid NCCT StrokeK222884 · 510(k) | iSchemaView, Inc. | Radiology | database entry | |
| CINAK221716 · 510(k) | AVICENNA.AI | Radiology | database entry | |
| BriefCaseK221330 · 510(k) | Aidoc Medical, Ltd. | Radiology | database entry | |
| Viz LVO ContaCTK223042 · 510(k) | Viz.ai, Inc. | Radiology | database entry | |
| BriefCaseK220709 · 510(k) | Aidoc Medical, Ltd. | Radiology | database entry | |
| BriefCaseK222329 · 510(k) | Aidoc Medical, Ltd. | Radiology | database entry | |
| Rapid ICHK221456 · 510(k) | iSchemaView Inc. | Radiology | database entry | |
| BriefCaseK222277 · 510(k) | Aidoc Medical, Ltd. | Radiology | database entry | |
| Viz SDHK220439 · 510(k) | Viz.ai, Inc. | Radiology | database entry | |
| BriefCaseK221314 · 510(k) | Aidoc Medical, Ltd. | Radiology | database entry | |
| Rapid LVOK221248 · 510(k) | iSchemaView Inc. | Radiology | database entry | |
| BriefCaseK221240 · 510(k) | Aidoc Medical, Ltd. | Radiology | database entry | |
| Rapid PE Triage and NotificationK220499 · 510(k) | iSchemaView Inc. | Radiology | database entry | |
| BriefCaseK213886 · 510(k) | Aidoc Medical, Ltd. | Radiology | database entry | |
| BriefCaseK213721 · 510(k) | Aidoc Medical, Ltd. | Radiology | database entry | |
| syngo.CT Brain HemorrhageK203260 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | database entry | |
| StrokeSENS LVOK212261 · 510(k) | Circle Neurovascular Imaging, Inc | Radiology | database entry | |
| InferRead CT Stroke.AIK211179 · 510(k) | Infervision Medical Technology Co., Ltd. | Radiology | database entry | |
| HALOK211788 · 510(k) | Nico.Lab B.V. | Radiology | database entry | |
| CINA CHESTK210237 · 510(k) | Avicenna.AI | Radiology | database entry | |
| Viz ICHK210209 · 510(k) | Viz.ai, Inc. | Radiology | database entry | |
| BriefCaseK203508 · 510(k) | Aidoc Medical, Ltd. | Radiology | database entry | |
| HALOK200873 · 510(k) | NICo-Lab B.V. | Radiology | database entry | |
| BriefCaseK201020 · 510(k) | Aidoc Medical, Ltd. | Radiology | database entry | |
| AccipiolxK201310 · 510(k) | MaxQ Al Ltd. | Radiology | database entry | |
| Rapid LVOK200941 · 510(k) | iSchemaView Inc. | Radiology | database entry | |
| CINAK200855 · 510(k) | AVICENNA.AI | Radiology | database entry | |
| BriefCaseK193298 · 510(k) | Aidoc Medical, Ltd. | Radiology | database entry | |
| qERK200921 · 510(k) | Qure.ai Technologies | Radiology | database entry | |
| NinesAIK193351 · 510(k) | Nines, Inc. | Radiology | database entry | |
| CuraRad-ICHK192167 · 510(k) | CuraCloud Corp. | Radiology | database entry | |
| Rapid ICHK193087 · 510(k) | iSchemaView Incorporated | Radiology | database entry | |
| Viz ICHK193658 · 510(k) | Viz.ai, Inc. | Radiology | database entry | |
| BriefCaseK192383 · 510(k) | Aidoc Medical, Ltd. | Radiology | database entry | |
| DeepCTK182875 · 510(k) | Deep01 Limited | Radiology | database entry | |
| HealthICHK190424 · 510(k) | Zebra Medical Vision Ltd. | Radiology | database entry | |
| BriefCaseK190896 · 510(k) | Aidoc Medical, Ltd. | Radiology | database entry | |
| BriefCaseK190072 · 510(k) | Aidoc Medical, Ltd. | Radiology | database entry | |
| AccipiolxK182177 · 510(k) | MaxQ-Al Ltd. | Radiology | database entry | |
| BriefCaseK180647 · 510(k) | Aidoc Medical, Ltd. | Radiology | database entry | |
| ContaCTDEN170073 · De Novo | Viz.Al, Inc. | Radiology | database entry |
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