Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
QAS — Predicate Candidate Screening
87 FDA 510(k) clearances under this product code; the 50 most recent screened below.
104 daysmedian FDA review time
224 days90th percentile
87clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261085 | Rapid Vessel Occlusion (Rapid VO) | iSchemaview | 2026-07-13 | 103 | 0 |
| K260729 | Vascular Assist Occlusion Triage (VAOT) (v1.0) | GuideAI Health | 2026-06-18 | 104 | 0 |
| K261317 | BriefCase-Triage | Aidoc Medical , Ltd. | 2026-05-14 | 23 | 0 |
| K253163 | EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100 | Ever Fortune.Ai, Co., Ltd. | 2026-04-22 | 208 | 0 |
| K252421 | JLK-NCCT | JLK, Inc. | 2026-03-24 | 235 | 0 |
| K253818 | Annalise Enterprise | Harrison-AI Medical Pty, Ltd. | 2026-03-03 | 95 | 0 |
| K253578 | BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Per | Aidoc Medical , Ltd. | 2026-02-26 | 101 | 0 |
| K251195 | BriefCase-Triage | Aidoc Medical , Ltd. | 2026-01-27 | 285 | 0 |
| K252970 | BriefCase-Triage: CARE Multi-triage CT Body | Aidoc Medical , Ltd. | 2026-01-07 | 112 | 0 |
| K250694 | Scaida BrainCT-ICH (v1.0) | Mlhealth 360 | 2025-11-25 | 263 | 0 |
| K252366 | a2z-Unified-Triage | A2z Radiology Ai, Inc. | 2025-11-24 | 117 | 0 |
| K253265 | BriefCase-Triage | Aidoc Medical , Ltd. | 2025-11-06 | 38 | 0 |
| K251610 | qER-CTA (v1.0) | Qure.Ai Technologies | 2025-09-08 | 104 | 0 |
| K251533 | Rapid Obstructive Hydrocephalus, Rapid OH | Ischemaview, Inc. | 2025-09-04 | 108 | 0 |
| K251983 | Brainomix 360 Triage Stroke | Brainomix Limited | 2025-08-26 | 60 | 0 |
| K251590 | Methinks CTA Stroke | Methinks Software, S.L | 2025-08-20 | 89 | 0 |
| K251151 | Rapid CTA 360 | Ischemaview | 2025-07-16 | 93 | 0 |
| K250685 | Methinks NCCT Stroke | Methinks Software, S.L | 2025-06-16 | 102 | 0 |
| K251406 | BriefCase-Triage | Aidoc Medical , Ltd. | 2025-05-30 | 24 | 0 |
| K243145 | syngo.CT LVO Detection | Siemens Medical Solutions USA, Inc. | 2025-04-10 | 192 | 0 |
| K243611 | JLK-SDH | JLK, Inc. | 2025-03-03 | 101 | 0 |
| K242821 | EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT- | Ever Fortune.Ai, Co., Ltd. | 2025-02-20 | 155 | 0 |
| K250248 | BriefCase-Triage | Aidoc Medical , Ltd. | 2025-02-14 | 18 | 0 |
| K243363 | JLK-ICH | JLK, Inc. | 2025-01-03 | 66 | 0 |
| K241923 | EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-1 | Ever Fortune.Ai, Co., Ltd. | 2024-12-06 | 158 | 0 |
| K241719 | NeuroICH | Neurocareai, Inc. | 2024-11-07 | 146 | 0 |
| K242837 | BriefCase-Triage | Aidoc Medical , Ltd. | 2024-10-18 | 29 | 0 |
| K241480 | JBS-LVO | JLK, Inc. | 2024-09-27 | 126 | 0 |
| K242292 | uAI Easy Triage ICH | Shanghai United Imaging Intelligence Co., Ltd. | 2024-09-24 | 53 | 0 |
| K240942 | CINA-CSpine | Avicenna.Ai | 2024-09-12 | 160 | 0 |
| K241727 | BriefCase-Triage | Aidoc Medical , Ltd. | 2024-07-12 | 28 | 0 |
| K240353 | Hyper Insight - ICH | Sk, Inc. | 2024-07-01 | 147 | 0 |
| K233247 | Heuron ICH | Heuron Co., Ltd. | 2024-05-15 | 230 | 0 |
| K240291 | EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM | Ever Fortune.Ai, Co., Ltd. | 2024-04-08 | 67 | 0 |
| K232431 | syngo.CT Brain Hemorrhage | Siemens Medical Solutions USA, Inc. | 2024-03-22 | 224 | 0 |
| K233968 | CINA-iPE | Avicenna.Ai | 2024-03-13 | 89 | 0 |
| K232496 | Brainomix 360 Triage Stroke | Brainomix Limited | 2023-11-21 | 96 | 0 |
| K232751 | BriefCase-Triage | Aidoc Medical , Ltd. | 2023-10-30 | 52 | 0 |
| K232436 | Rapid SDH | Ischemaview, Inc. | 2023-10-25 | 72 | 0 |
| K231025 | EFAI NeuroSuite CT ICH Assessment System | Ever Fortune.Ai, Co., Ltd. | 2023-10-04 | 176 | 0 |
| K231837 | Brainomix 360 Triage LVO | Brainomix Limited | 2023-09-28 | 98 | 0 |
| K231767 | Annalise Enterprise CTB Triage Trauma | Annalise-Ai Pty , Ltd. | 2023-09-22 | 98 | 0 |
| K231384 | Annalise Enterprise CTB Triage Trauma | Annalise-Ai Pty , Ltd. | 2023-09-22 | 133 | 0 |
| K231094 | Annalise Enterprise CTB Triage-OH | Annalise-Ai Pty , Ltd. | 2023-08-15 | 119 | 0 |
| K231195 | Brainomix 360 Triage ICH | Brainomix Limited | 2023-07-27 | 91 | 0 |
| K223240 | Annalise Enterprise CTB Triage Trauma | Annalise-Ai Pty , Ltd. | 2023-04-03 | 165 | 0 |
| K222884 | Rapid NCCT Stroke | Ischemaview, Inc. | 2023-03-02 | 161 | 0 |
| K221716 | CINA | Avicenna.Ai | 2022-11-22 | 162 | 0 |
| K221330 | BriefCase | Aidoc Medical , Ltd. | 2022-11-18 | 196 | 0 |
| K223042 | Viz LVO ContaCT | Viz. Ai, Inc. | 2022-10-21 | 22 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda