FDA product code QAS: Radiological Computer-Assisted Triage And Notification Software
QAS is the FDA product code for radiological computer-assisted triage and notification software. It is a Class II device, regulated under 21 CFR 892.2080 and reviewed by the Radiology panel. FDA has cleared 87 510(k) submissions under QAS, 63 in the last five years, from 32 different applicants. The average 510(k) review took 118 days (median 104); 123 days on average over the last three years. 1 De Novo request was granted under it.
Definition
Radiological computer-assisted triage and notification software is an image processing device intended to aid in prioritization and triage of time sensitive patient detection and diagnosis based on the analysis of medical images acquired from radiological signal acquisition systems. The device identifies or prioritizes time sensitive imaging for review by prespecified clinical users based on software-based image analysis but does not provide information from the image analysis other than triage and notification .
Classification
| Field | Value |
|---|---|
| Device name | Radiological Computer-Assisted Triage And Notification Software |
| Device class | Class II |
| Regulation | 21 CFR 892.2080 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
510(k) clearances per year for QAS
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 2 | 110 |
| 2019 | 5 | 128 |
| 2020 | 12 | 129 |
| 2021 | 5 | 79 |
| 2022 | 15 | 121 |
| 2023 | 11 | 115 |
| 2024 | 12 | 121 |
| 2025 | 15 | 102 |
| 2026 | 10 | 145 |
Compare with all 510(k) review times · Search every QAS clearance
Top QAS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Aidoc Medical , Ltd. | 25 | 2026-05-14 |
| Ischemaview, Inc. | 7 | 2025-09-04 |
| Ever Fortune.Ai, Co., Ltd. | 5 | 2026-04-22 |
| Avicenna.Ai | 5 | 2024-09-12 |
| JLK, Inc. | 4 | 2026-03-24 |
27 more applicants have QAS clearances. See the full list in Caduvo.
Most recent QAS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260906 | A2z Radiology Ai, Inc. | a2z-Abdo-Triage | 2026-09-16 | 181 |
| K261085 | iSchemaview | Rapid Vessel Occlusion (Rapid VO) | 2026-07-13 | 103 |
| K260729 | GuideAI Health | Vascular Assist Occlusion Triage (VAOT) (v1.0) | 2026-06-18 | 104 |
| K261317 | Aidoc Medical , Ltd. | BriefCase-Triage | 2026-05-14 | 23 |
| K253163 | Ever Fortune.Ai, Co., Ltd. | EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100) | 2026-04-22 | 208 |
Recalls for QAS devices
openFDA lists no recalls for product code QAS.
Frequently asked questions
What is FDA product code QAS?
QAS is the FDA product code for radiological computer-assisted triage and notification software. It is a Class II device, regulated under 21 CFR 892.2080 and reviewed by the Radiology panel.
What device class is QAS?
Class II, regulation 21 CFR 892.2080. Typical premarket route: 510(k).
How long does a 510(k) take for product code QAS?
Across 87 cleared submissions the average was 118 days from receipt to decision (median 104).
Which companies have the most QAS clearances?
Aidoc Medical , Ltd. (25); Ischemaview, Inc. (7); Ever Fortune.Ai, Co., Ltd. (5); Avicenna.Ai (5); JLK, Inc. (4).
Next steps
- Run an FDA pathway report with predicate devices for product code QAS
- Run a recall and safety report across every QAS manufacturer
- Watch product code QAS for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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