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 |
|---|---|---|---|
| Oct 9, 2026 | K262301 | Rapid ICH (v4.0) Ischemaview, Inc. | QAS |
| Sep 16, 2026 | K260906 | a2z-Abdo-Triage A2z Radiology Ai, Inc. | QAS |
| Jul 13, 2026 | K261085 | Rapid Vessel Occlusion (Rapid VO) iSchemaview | QAS |
| Jun 18, 2026 | K260729 | Vascular Assist Occlusion Triage (VAOT) (v1.0) GuideAI Health | QAS |
| May 14, 2026 | K261317 | BriefCase-Triage Aidoc Medical , Ltd., IL | QAS |
| Apr 22, 2026 | K253163 | EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100) Ever Fortune.Ai, Co., Ltd., TW | QAS |
| Mar 24, 2026 | K252421 | JLK-NCCT JLK, Inc., KR | QAS |
| Mar 3, 2026 | K253818 | Annalise Enterprise Harrison-AI Medical Pty, Ltd., AU | QAS |
| Feb 26, 2026 | K253578 | BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture Aidoc Medical , Ltd., IL | QAS |
| Jan 27, 2026 | K251195 | BriefCase-Triage Aidoc Medical , Ltd., IL | QAS |
| Jan 7, 2026 | K252970 | BriefCase-Triage: CARE Multi-triage CT Body Aidoc Medical , Ltd., IL | QAS |
| Nov 25, 2025 | K250694 | Scaida BrainCT-ICH (v1.0) Mlhealth 360, CA | QAS |
| Nov 24, 2025 | K252366 | a2z-Unified-Triage A2z Radiology Ai, Inc. | QAS |
| Nov 6, 2025 | K253265 | BriefCase-Triage Aidoc Medical , Ltd., IL | QAS |
| Sep 8, 2025 | K251610 | qER-CTA (v1.0) Qure.Ai Technologies, IN | QAS |
| Sep 4, 2025 | K251533 | Rapid Obstructive Hydrocephalus, Rapid OH Ischemaview, Inc. | QAS |
| Aug 26, 2025 | K251983 | Brainomix 360 Triage Stroke Brainomix Limited, GB | QAS |
| Aug 20, 2025 | K251590 | Methinks CTA Stroke Methinks Software, S.L, ES | QAS |
| Jul 16, 2025 | K251151 | Rapid CTA 360 Ischemaview | QAS |
| Jun 16, 2025 | K250685 | Methinks NCCT Stroke Methinks Software, S.L, ES | QAS |
| May 30, 2025 | K251406 | BriefCase-Triage Aidoc Medical , Ltd., IL | QAS |
| Apr 10, 2025 | K243145 | syngo.CT LVO Detection Siemens Medical Solutions USA, Inc. | QAS |
| Mar 3, 2025 | K243611 | JLK-SDH JLK, Inc., KR | QAS |
| Feb 20, 2025 | K242821 | EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100) Ever Fortune.Ai, Co., Ltd., TW | QAS |
| Feb 14, 2025 | K250248 | BriefCase-Triage Aidoc Medical , Ltd., IL | QAS |
| Jan 3, 2025 | K243363 | JLK-ICH JLK, Inc., KR | QAS |
| Dec 6, 2024 | K241923 | EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100) Ever Fortune.Ai, Co., Ltd., TW | QAS |
| Nov 7, 2024 | K241719 | NeuroICH Neurocareai, Inc. | QAS |
| Oct 18, 2024 | K242837 | BriefCase-Triage Aidoc Medical , Ltd., IL | QAS |
| Sep 27, 2024 | K241480 | JBS-LVO JLK, Inc., KR | QAS |
| Sep 24, 2024 | K242292 | uAI Easy Triage ICH Shanghai United Imaging Intelligence Co., Ltd., CN | QAS |
| Sep 12, 2024 | K240942 | CINA-CSpine Avicenna.Ai, FR | QAS |
| Jul 12, 2024 | K241727 | BriefCase-Triage Aidoc Medical , Ltd., IL | QAS |
| Jul 1, 2024 | K240353 | Hyper Insight - ICH Sk, Inc., KR | QAS |
| May 15, 2024 | K233247 | Heuron ICH Heuron Co., Ltd., KR | QAS |
| Apr 8, 2024 | K240291 | EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM Ever Fortune.Ai, Co., Ltd., TW | QAS |
| Mar 22, 2024 | K232431 | syngo.CT Brain Hemorrhage Siemens Medical Solutions USA, Inc. | QAS |
| Mar 13, 2024 | K233968 | CINA-iPE Avicenna.Ai, FR | QAS |
| Nov 21, 2023 | K232496 | Brainomix 360 Triage Stroke Brainomix Limited, GB | QAS |
| Oct 30, 2023 | K232751 | BriefCase-Triage Aidoc Medical , Ltd., IL | QAS |
| Oct 25, 2023 | K232436 | Rapid SDH Ischemaview, Inc. | QAS |
| Oct 4, 2023 | K231025 | EFAI NeuroSuite CT ICH Assessment System Ever Fortune.Ai, Co., Ltd., TW | QAS |
| Sep 28, 2023 | K231837 | Brainomix 360 Triage LVO Brainomix Limited, GB | QAS |
| Sep 22, 2023 | K231767 | Annalise Enterprise CTB Triage Trauma Annalise-Ai Pty , Ltd., AU | QAS |
| Sep 22, 2023 | K231384 | Annalise Enterprise CTB Triage Trauma Annalise-Ai Pty , Ltd., AU | QAS |
| Aug 15, 2023 | K231094 | Annalise Enterprise CTB Triage-OH Annalise-Ai Pty , Ltd., AU | QAS |
| Jul 27, 2023 | K231195 | Brainomix 360 Triage ICH Brainomix Limited, GB | QAS |
| Apr 3, 2023 | K223240 | Annalise Enterprise CTB Triage Trauma Annalise-Ai Pty , Ltd., AU | QAS |
| Mar 2, 2023 | K222884 | Rapid NCCT Stroke Ischemaview, Inc. | QAS |
| Nov 22, 2022 | K221716 | CINA Avicenna.Ai, FR | QAS |
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