BEUDAMED
    Product Code: QAS FDA class 2 21 CFR 892.2080

    Radiological Computer-Assisted Triage And Notification Software

    Radiology

    The Radiological Computer-Assisted Triage and Notification Software is an image processing device intended to aid in the prioritization and triage of time-sensitive patient detection and diagnosis by analyzing medical images from radiological acquisition systems, identifying and flagging urgent findings for review by prespecified clinical users without providing diagnostic interpretation beyond triage and notification. It is classified as a Class 2 device under regulation 892.2080, requiring 510(k) premarket notification, and falls within the Radiology (RA) medical specialty. The product code is QAS. It is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    86
    FEI Numbers
    19
    Registration Numbers
    19
    Unique Applicants
    32
    Years Active
    8

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    Basic Information

    Product Code
    QAS
    Device Class
    FDA class 2
    Regulation Number
    892.2080
    Medical Specialty
    Radiology
    Review Panel
    RA
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    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 .

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 86 510(k) clearances via K numbers.

    K Number Device Name
    K260729 Vascular Assist Occlusion Triage (VAOT) (v1.0)
    K261317 BriefCase-Triage
    K253163 EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100)
    K252421 JLK-NCCT
    K253818 Annalise Enterprise
    K253578 BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device
    K251195 BriefCase-Triage
    K252970 BriefCase-Triage: CARE Multi-triage CT Body
    K250694 Scaida BrainCT-ICH (v1.0)
    K252366 a2z-Unified-Triage
    K253265 BriefCase-Triage
    K251610 qER-CTA (v1.0)
    K251533 Rapid Obstructive Hydrocephalus, Rapid OH
    K251983 Brainomix 360 Triage Stroke
    K251590 Methinks CTA Stroke
    K251151 Rapid CTA 360
    K250685 Methinks NCCT Stroke
    K251406 BriefCase-Triage
    K243145 syngo.CT LVO Detection
    K243611 JLK-SDH
    K242821 EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100)
    K250248 BriefCase-Triage
    K243363 JLK-ICH
    K241923 EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100)
    K241719 NeuroICH
    K242837 BriefCase-Triage
    K241480 JBS-LVO
    K242292 uAI Easy Triage ICH
    K240942 CINA-CSpine
    K241727 BriefCase-Triage
    K240353 Hyper Insight - ICH
    K233247 Heuron ICH
    K240291 EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM
    K232431 syngo.CT Brain Hemorrhage
    K233968 CINA-iPE
    K232496 Brainomix 360 Triage Stroke
    K232751 BriefCase-Triage
    K232436 Rapid SDH
    K231025 EFAI NeuroSuite CT ICH Assessment System
    K231837 Brainomix 360 Triage LVO
    K231767 Annalise Enterprise CTB Triage Trauma
    K231384 Annalise Enterprise CTB Triage Trauma
    K231094 Annalise Enterprise CTB Triage-OH
    K231195 Brainomix 360 Triage ICH
    K223240 Annalise Enterprise CTB Triage Trauma
    K222884 Rapid NCCT Stroke
    K221716 CINA
    K221330 BriefCase
    K223042 Viz LVO ContaCT
    K220709 BriefCase
    K222329 BriefCase
    K221456 Rapid ICH
    K222277 BriefCase
    K220439 Viz SDH
    K221314 BriefCase
    K221248 Rapid LVO
    K221240 BriefCase
    K220499 Rapid PE Triage and Notification (PETN)
    K213886 BriefCase
    K213721 BriefCase
    K203260 syngo.CT Brain Hemorrhage
    K212261 StrokeSENS LVO
    K211179 InferRead CT Stroke.AI
    K211788 HALO
    K210237 CINA CHEST
    K210209 Viz ICH
    K203508 BriefCase
    K200873 HALO
    K201020 BriefCase
    K201310 Accipiolx
    K200941 Rapid LVO
    K200855 CINA
    K193298 BriefCase
    K200921 qER
    K193351 NinesAI
    K192167 CuraRad-ICH
    K193087 Rapid ICH
    K193658 Viz ICH
    K192383 BriefCase
    K182875 DeepCT
    K190424 HealthICH
    K190896 BriefCase
    K190072 BriefCase
    K182177 Accipiolx
    K180647 BriefCase
    DEN170073 ContaCT

    FEI Numbers

    This FDA classification entry is associated with 19 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 19 registration numbers. Click on an entry to view related FDA registrations.