FDA product code · Radiology
QASRadiological Computer-Assisted Triage And Notification Software
Product code QAS covers Radiological Computer-Assisted Triage And Notification Software, a Class II device regulated under 21 CFR 892.2080. FDA has cleared 86 devices in this code, 16 of them in the last 12 months. Median review time across the 86 most recent decisions is 103 days. openFDA lists no recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 892.2080
- Review panel
- Radiology
- Clearances
- 86
What is happening in QAS right now?
QAS (Radiological Computer-Assisted Triage And Notification Software) has two findings, most consequential first. 4 first-time filers in the last 12 months, including GuideAI Health and Harrison-AI Medical Pty, Ltd (K260729, K253818, K250694, K252366). The code is crowded, scoring 75 of 100 — 28 companies hold a clearance here and 16 arrived in the last 12 months (QAS:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| New entrant | Worth knowing | K260729, K253818, K250694, K252366 |
| Crowding | Context | QAS:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
What does product code QAS cover?
QAS is FDA's product code for Radiological Computer-Assisted Triage And Notification Software, a Class II device regulated under 21 CFR 892.2080.
Computer-assisted triage and notification software intended to aid in prioritisation of medical images.
Source: openFDA device/classification · record QAS · retrieved
How many devices has FDA cleared in QAS?
FDA has cleared 86 devices under product code QAS since the 510(k) programme began in 1976, 16 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261085 | Rapid Vessel Occlusion (Rapid VO) | iSchemaview | |
| K260729 | Vascular Assist Occlusion Triage (VAOT) (v1.0) | GuideAI Health | |
| K261317 | BriefCase-Triage | Aidoc Medical , Ltd. | |
| K253163 | EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100) | Ever Fortune.Ai, Co., Ltd. | |
| K252421 | JLK-NCCT | JLK, Inc. | |
| K253818 | Annalise Enterprise | Harrison-AI Medical Pty, Ltd. | |
| K253578 | BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device | Aidoc Medical , Ltd. | |
| K251195 | BriefCase-Triage | Aidoc Medical , Ltd. | |
| K252970 | BriefCase-Triage: CARE Multi-triage CT Body | Aidoc Medical , Ltd. | |
| K250694 | Scaida BrainCT-ICH (v1.0) | Mlhealth 360 |
How long does FDA review take for QAS?
The median FDA review time for QAS is 103 days, measured across the 86 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in QAS?
openFDA lists no recall records against product code QAS. That is the absence of a record, not a guarantee of safety.
Source: openFDA device/recall · retrieved
How many adverse events are reported for QAS?
MAUDE holds no adverse-event reports naming product code QAS.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Who has entered QAS in the last year?
4 companies filed in QAS for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| GuideAI Health | K260729 | |
| Harrison-AI Medical Pty, Ltd. | K253818 | |
| Mlhealth 360 | K250694 | |
| A2z Radiology Ai, Inc. | K252366 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in QAS?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in QAS?
Across the 86 most recent decisions, these applicants filed most often in QAS.
| Applicant | Recent clearances |
|---|---|
| Aidoc Medical , Ltd. | 25 |
| Ischemaview, Inc. | 7 |
| Avicenna.Ai | 5 |
| Ever Fortune.Ai, Co., Ltd. | 5 |
| Annalise-Ai Pty , Ltd. | 4 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
One company in QAS files under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| Ischemaview Incorporated | 10 | 4 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch QAS
Get an email the morning anything changes in QAS — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.