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 |
| K232751 | Aidoc Medical, Ltd. | BriefCase-Triage | 10/30/2023 |
| K241727 | Aidoc Medical, Ltd. | BriefCase-Triage | 07/12/2024 |
| K242837 | Aidoc Medical, Ltd. | BriefCase-Triage | 10/18/2024 |
| K250248 | Aidoc Medical, Ltd. | BriefCase-Triage | 02/14/2025 |
| K251406 | Aidoc Medical, Ltd. | BriefCase-Triage | 05/30/2025 |
| 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 |
| K240942 | Avicenna.AI | CINA-CSpine | 09/12/2024 |
| K233968 | Avicenna.AI | CINA-iPE | 03/13/2024 |
| K231195 | Brainomix Limited | Brainomix 360 Triage ICH | 07/27/2023 |
| K231837 | Brainomix Limited | Brainomix 360 Triage LVO | 09/28/2023 |
| K232496 | Brainomix Limited | Brainomix 360 Triage Stroke | 11/21/2023 |
| 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 |
| K240291 | Ever Fortune.AI, Co., Ltd. | EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM | 04/08/2024 |
| K242821 | Ever Fortune.AI, Co., Ltd. | EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100) | 02/20/2025 |
| K241923 | Ever Fortune.AI, Co., Ltd. | EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100) | 12/06/2024 |
| K233247 | Heuron Co., Ltd. | Heuron ICH | 05/15/2024 |
| K211179 | Infervision Medical Technology Co., Ltd. | InferRead CT Stroke.AI | 08/12/2021 |
| K251151 | iSchemaView | Rapid CTA 360 | 07/16/2025 |
| 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 |
| K232436 | iSchemaView, Inc. | Rapid SDH | 10/25/2023 |
| K241480 | JLK, Inc. | JBS-LVO | 09/27/2024 |
| K243363 | JLK, Inc. | JLK-ICH | 01/03/2025 |
| K243611 | JLK, Inc. | JLK-SDH | 03/03/2025 |
| K201310 | MaxQ Al Ltd. | Accipiolx | 08/07/2020 |
| K182177 | MaxQ-Al Ltd. | Accipiolx | 10/26/2018 |
| K250685 | Methinks Software S.L. | Methinks NCCT Stroke | 06/16/2025 |
| K241719 | Neurocareai Inc. | NeuroICH | 11/07/2024 |
| 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 |
| K242292 | Shanghai United Imaging Intelligence Co., Ltd. | uAI Easy Triage ICH | 09/24/2024 |
| K203260 | Siemens Medical Solutions USA, Inc. | syngo.CT Brain Hemorrhage | 01/28/2022 |
| K232431 | Siemens Medical Solutions USA, Inc. | syngo.CT Brain Hemorrhage | 03/22/2024 |
| K243145 | Siemens Medical Solutions USA, Inc. | syngo.CT LVO Detection | 04/10/2025 |
| K240353 | SK Inc. | Hyper Insight - ICH | 07/01/2024 |
| 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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