FDA 510(k) Applications for Medical Device Product Code "QAS"

FDA 510(k) Number Applicant Device Name Decision Date
K221314 Aidoc Medical, Ltd. BriefCase 06/03/2022
K222277 Aidoc Medical, Ltd. BriefCase 08/26/2022
K192383 Aidoc Medical, Ltd. BriefCase 12/20/2019
K193298 Aidoc Medical, Ltd. BriefCase 06/19/2020
K201020 Aidoc Medical, Ltd. BriefCase 08/26/2020
K220709 Aidoc Medical, Ltd. BriefCase 10/07/2022
K221240 Aidoc Medical, Ltd. BriefCase 05/17/2022
K222329 Aidoc Medical, Ltd. BriefCase 09/28/2022
K213721 Aidoc Medical, Ltd. BriefCase 03/21/2022
K221330 Aidoc Medical, Ltd. BriefCase 11/18/2022
K203508 Aidoc Medical, Ltd. BriefCase 12/29/2020
K213886 Aidoc Medical, Ltd. BriefCase 04/26/2022
K190072 Aidoc Medical, Ltd. BriefCase 04/15/2019
K190896 Aidoc Medical, Ltd. BriefCase 05/31/2019
K180647 Aidoc Medical, Ltd. BriefCase 08/01/2018
K223240 Annalise-AI Pty Ltd Annalise Enterprise CTB Triage Trauma 04/03/2023
K231767 Annalise-AI Pty Ltd Annalise Enterprise CTB Triage Trauma 09/22/2023
K231094 Annalise-AI Pty Ltd Annalise Enterprise CTB Triage-OH 08/15/2023
K231384 Annalise-AI Pty Ltd. Annalise Enterprise CTB Triage Trauma 09/22/2023
K200855 AVICENNA.AI CINA 06/24/2020
K221716 AVICENNA.AI CINA 11/22/2022
K210237 Avicenna.AI CINA CHEST 05/19/2021
K231195 Brainomix Limited Brainomix 360 Triage ICH 07/27/2023
K231837 Brainomix Limited Brainomix 360 Triage LVO 09/28/2023
K212261 Circle Neurovascular Imaging, Inc StrokeSENS LVO 10/14/2021
K192167 CuraCloud Corp. CuraRad-ICH 04/13/2020
K182875 Deep01 Limited DeepCT 07/10/2019
K231025 Ever Fortune.AI Co., Ltd. EFAI NeuroSuite CT ICH Assessment System 10/04/2023
K211179 Infervision Medical Technology Co., Ltd. InferRead CT Stroke.AI 08/12/2021
K221456 iSchemaView Inc. Rapid ICH 09/12/2022
K221248 iSchemaView Inc. Rapid LVO 05/31/2022
K200941 iSchemaView Inc. Rapid LVO 07/09/2020
K220499 iSchemaView Inc. Rapid PE Triage and Notification (PETN) 05/17/2022
K193087 iSchemaView Incorporated Rapid ICH 03/31/2020
K222884 iSchemaView, Inc. Rapid NCCT Stroke 03/02/2023
K201310 MaxQ Al Ltd. Accipiolx 08/07/2020
K182177 MaxQ-Al Ltd. Accipiolx 10/26/2018
K200873 NICo-Lab B.V. HALO 11/20/2020
K211788 Nico.Lab B.V. HALO 07/08/2021
K193351 Nines, Inc. NinesAI 04/21/2020
K200921 Qure.ai Technologies qER 06/17/2020
K203260 Siemens Medical Solutions USA, Inc. syngo.CT Brain Hemorrhage 01/28/2022
K210209 Viz.ai, Inc. Viz ICH 03/23/2021
K193658 Viz.ai, Inc. Viz ICH 03/18/2020
K223042 Viz.ai, Inc. Viz LVO ContaCT 10/21/2022
K220439 Viz.ai, Inc. Viz SDH 07/25/2022
DEN170073 Viz.Al, Inc. ContaCT 02/13/2018
K190424 Zebra Medical Vision Ltd. HealthICH 06/13/2019


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