Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
QFM — Predicate Candidate Screening
41 FDA 510(k) clearances under this product code; the 50 most recent screened below.
144 daysmedian FDA review time
262 days90th percentile
41clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253751 | CXRDetectAI | Neurocareai, Inc. (Dba Savelife.Ai) | 2026-07-08 | 225 | 0 |
| K252954 | MammoSightAI | Neurocareai, Inc. (Dba Savelife.Ai) | 2026-05-04 | 230 | 0 |
| K252482 | CogNet AI-MT+ | Medcognetics, Inc. | 2025-12-11 | 126 | 0 |
| K250831 | Annalise Enterprise | Annalise-Ai | 2025-04-23 | 35 | 0 |
| K243808 | Rayvolve PTX-PE | AZmed | 2025-03-21 | 100 | 0 |
| K243548 | BriefCase-Triage | Aidoc Medical , Ltd. | 2024-12-11 | 26 | 0 |
| K241439 | VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage | Vuno, Inc. | 2024-11-15 | 178 | 0 |
| K240612 | CINA-VCF | Avicenna.Ai | 2024-05-31 | 87 | 0 |
| K233108 | VinDr-Mammo | Vinbigdata Joint Stock Company | 2024-05-23 | 239 | 0 |
| K232410 | SmartChest | Milvue | 2024-05-10 | 274 | 0 |
| K231871 | Radify Triage | Envisionit Deepai, Ltd. | 2024-01-17 | 205 | 0 |
| K223754 | BraveCX | Bering, Ltd. | 2023-11-09 | 329 | 0 |
| K230899 | qXR-PTX-PE | Qure.Ai Technologies | 2023-08-22 | 144 | 0 |
| K230074 | Rapid Aneurysm Triage and Notification | Ischemaview, Inc. | 2023-07-27 | 198 | 0 |
| K222179 | Annalise Enterprise CXR Triage Trauma | Annalise-Ai Pty , Ltd. | 2023-03-28 | 249 | 0 |
| K222268 | Annalise Enterprise CXR Triage Trauma | Annalise-Ai Pty , Ltd. | 2023-03-28 | 243 | 0 |
| K223443 | Viz AAA | Viz. Ai, Inc. | 2023-03-17 | 123 | 0 |
| K230020 | BriefCase | Aidoc Medical , Ltd. | 2023-02-01 | 29 | 0 |
| K221868 | QOCA image Smart CXR Image Processing System | Quanta Computer, Inc. | 2023-01-27 | 214 | 0 |
| K222692 | BriefCase | Aidoc Medical , Ltd. | 2022-12-05 | 90 | 0 |
| K221552 | EFAI ChestSuite XR Pneumothorax Assessment System | Ever Fortune.Ai, Co., Ltd. | 2022-11-08 | 161 | 0 |
| K220080 | CogNet QmTRIAGE | Medcognetics, Inc. | 2022-09-29 | 262 | 0 |
| K222076 | EFAI ChestSuite XR Pleural Effusion Assessment System | Ever Fortune.Ai, Co., Ltd. | 2022-09-08 | 56 | 0 |
| K221241 | DrAid for Radiology v1 | Vinbrain Joint Stock Company | 2022-09-01 | 125 | 0 |
| K214043 | BriefCase | Aidoc Medical , Ltd. | 2022-03-14 | 81 | 0 |
| K213566 | ClearRead Xray Pneumothorax | Riverain Technologies, Inc. | 2022-03-10 | 121 | 0 |
| K213941 | Annalise Enterprise CXR Triage Pneumothorax | Annalise-Ai | 2022-02-24 | 70 | 0 |
| K213319 | Viz ANEURYSM, Viz ANX | Viz. Ai, Inc. | 2022-02-18 | 137 | 0 |
| K211803 | HealthPPT | Zebra Medical Vision, Ltd. | 2021-12-15 | 187 | 0 |
| K211733 | Lunit INSIGHT CXR Triage | Lunit, Inc. | 2021-11-10 | 159 | 0 |
| K203517 | Saige-Q | DeepHealth, Inc. | 2021-04-16 | 137 | 0 |
| K202992 | BriefCase, RIB Fractures Triage (RibFx) | Aidoc Medical , Ltd. | 2021-04-14 | 196 | 0 |
| K193271 | uAI EasyTriage-Rib | Shanghai United Imaging Intelligence Co., Ltd. | 2021-01-15 | 416 | 0 |
| K200905 | HealthMammo | Zebra Medical Vision, Ltd. | 2020-07-16 | 101 | 0 |
| K192901 | HealthVCF | Zebra Medical Vision, Ltd. | 2020-05-12 | 210 | 0 |
| K193300 | AIMI-Triage CXR PTX | Radlogics, Inc. | 2020-04-08 | 133 | 0 |
| K191556 | Red Dot | Behold.Ai Technologies Limited | 2020-02-28 | 261 | 0 |
| K192320 | HealthCXR | Zebra Medical Vision, Ltd. | 2019-11-26 | 92 | 0 |
| K183182 | Critical Care Suite | Ge Medical Systems, LLC | 2019-08-12 | 266 | 0 |
| K190362 | HealthPNX | Zebra Medical Vision, Ltd. | 2019-05-06 | 80 | 0 |
| K183285 | cmTriage | Curemetrix, Inc. | 2019-03-08 | 102 | 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