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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