Radiological Computer-Assisted Triage And Notification Software
Regulation 892.2080
14510(k)s in 12 months (89 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in QAS
| Company | 510(k)s | Recalls |
|---|---|---|
| Aidoc Medical , Ltd. | 25 | 0 |
| Ischemaview | 11 | 0 |
| Avicenna.Ai | 5 | 0 |
| Ever Fortune.Ai, Co., Ltd. | 5 | 0 |
| Annalise-Ai Pty , Ltd. | 4 | 0 |
| Brainomix Limited | 4 | 0 |
| JLK, Inc. | 4 | 0 |
| Viz. Ai, Inc. | 4 | 0 |
| Siemens Medical Solutions USA, Inc. | 3 | 0 |
| A2z Radiology Ai, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 18, 2022 | K221330 | BriefCase Aidoc Medical , Ltd., IL | QAS |
| Oct 21, 2022 | K223042 | Viz LVO ContaCT Viz. Ai, Inc. | QAS |
| Oct 7, 2022 | K220709 | BriefCase Aidoc Medical , Ltd., IL | QAS |
| Sep 28, 2022 | K222329 | BriefCase Aidoc Medical , Ltd., IL | QAS |
| Sep 12, 2022 | K221456 | Rapid ICH Ischemaview, Inc. | QAS |
| Aug 26, 2022 | K222277 | BriefCase Aidoc Medical , Ltd., IL | QAS |
| Jul 25, 2022 | K220439 | Viz SDH Viz. Ai, Inc. | QAS |
| Jun 3, 2022 | K221314 | BriefCase Aidoc Medical , Ltd., IL | QAS |
| May 31, 2022 | K221248 | Rapid LVO Ischemaview, Inc. | QAS |
| May 17, 2022 | K221240 | BriefCase Aidoc Medical , Ltd., IL | QAS |
| May 17, 2022 | K220499 | Rapid PE Triage and Notification (PETN) Ischemaview, Inc. | QAS |
| Apr 26, 2022 | K213886 | BriefCase Aidoc Medical , Ltd., IL | QAS |
| Mar 21, 2022 | K213721 | BriefCase Aidoc Medical , Ltd., IL | QAS |
| Jan 28, 2022 | K203260 | syngo.CT Brain Hemorrhage Siemens Medical Solutions USA, Inc. | QAS |
| Oct 14, 2021 | K212261 | StrokeSENS LVO Circle Neurovascular Imaging, Inc., CA | QAS |
| Aug 12, 2021 | K211179 | InferRead CT Stroke.AI Infervision Medical Technology Co., Ltd., CN | QAS |
| Jul 8, 2021 | K211788 | HALO Nicolab B.V., NL | QAS |
| May 19, 2021 | K210237 | CINA CHEST Avicenna.Ai, FR | QAS |
| Mar 23, 2021 | K210209 | Viz ICH Viz. Ai, Inc. | QAS |
| Dec 29, 2020 | K203508 | BriefCase Aidoc Medical , Ltd., IL | QAS |
| Nov 20, 2020 | K200873 | HALO Nico-Lab B.V., NL | QAS |
| Aug 26, 2020 | K201020 | BriefCase Aidoc Medical , Ltd., IL | QAS |
| Aug 7, 2020 | K201310 | Accipiolx Maxq AL , Ltd., IL | QAS |
| Jul 9, 2020 | K200941 | Rapid LVO Ischemaview, Inc. | QAS |
| Jun 24, 2020 | K200855 | CINA Avicenna.Ai, FR | QAS |
| Jun 19, 2020 | K193298 | BriefCase Aidoc Medical , Ltd., IL | QAS |
| Jun 17, 2020 | K200921 | qER Qure.Ai Technologies, IN | QAS |
| Apr 21, 2020 | K193351 | NinesAI Nines, Inc. | QAS |
| Apr 13, 2020 | K192167 | CuraRad-ICH Curacloud Corp. | QAS |
| Mar 31, 2020 | K193087 | Rapid ICH Ischemaview Incorporated | QAS |
| Mar 18, 2020 | K193658 | Viz ICH Viz. Ai, Inc. | QAS |
| Dec 20, 2019 | K192383 | BriefCase Aidoc Medical , Ltd., IL | QAS |
| Jul 10, 2019 | K182875 | DeepCT Deep01 Limited, TW | QAS |
| Jun 13, 2019 | K190424 | HealthICH Zebra Medical Vision, Ltd., IL | QAS |
| May 31, 2019 | K190896 | BriefCase Aidoc Medical , Ltd., IL | QAS |
| Apr 15, 2019 | K190072 | BriefCase Aidoc Medical , Ltd., IL | QAS |
| Oct 26, 2018 | K182177 | Accipiolx Maxq-Al , Ltd., IL | QAS |
| Aug 1, 2018 | K180647 | BriefCase Aidoc Medical , Ltd., IL | QAS |
| Feb 13, 2018 | DEN170073 | ContaCT Viz.Al, Inc. | QAS |
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