FDA Product Code QAS: Radiological Computer-assisted Triage And Notification Software
FDA product code QAS covers radiological computer-assisted triage and notification software.
These AI-powered tools automatically analyze radiological images and prioritize cases based on the likelihood of critical findings — such as intracranial hemorrhage, pneumothorax, or pulmonary embolism. They alert radiologists and clinicians to urgent cases, reducing time to diagnosis and treatment.
QAS devices are Class II medical devices, regulated under 21 CFR 892.2080 and reviewed by the FDA Radiology panel.
Leading manufacturers include Aidoc Medical , Ltd., Ischemaview, Inc. and Ever Fortune.Ai, Co., Ltd..
85
Total
84
Cleared
118d
Avg days
2018
Since
Growing category -
30 submissions in the last 2 years
vs 23 in the prior period
Consistent review times:
115d avg (recent)
FDA 510(k) Cleared Radiological Computer-assisted Triage And Notification Software Devices (Product Code QAS)
85 devices
Cleared
May 14, 2026
BriefCase-Triage
Aidoc Medical , Ltd.
Radiology
23d
Cleared
Apr 22, 2026
EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100)
Ever Fortune.Ai, Co., Ltd.
Radiology
208d
Cleared
Mar 24, 2026
JLK-NCCT
JLK, Inc.
Radiology
235d
Cleared
Mar 03, 2026
Annalise Enterprise
Harrison-AI Medical Pty, Ltd.
Radiology
95d
Cleared
Feb 26, 2026
BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax
Aidoc Medical , Ltd.
Radiology
101d
Cleared
Jan 27, 2026
BriefCase-Triage
Aidoc Medical , Ltd.
Radiology
285d
Cleared
Jan 07, 2026
BriefCase-Triage: CARE Multi-triage CT Body
Aidoc Medical , Ltd.
Radiology
112d
Cleared
Nov 25, 2025
Scaida BrainCT-ICH (v1.0)
Mlhealth 360
Radiology
263d
Cleared
Nov 24, 2025
a2z-Unified-Triage
A2z Radiology Ai, Inc.
Radiology
117d
Cleared
Nov 06, 2025
BriefCase-Triage
Aidoc Medical , Ltd.
Radiology
38d
Cleared
Sep 08, 2025
qER-CTA (v1.0)
Qure.Ai Technologies
Radiology
104d
Cleared
Sep 04, 2025
Rapid Obstructive Hydrocephalus, Rapid OH
Ischemaview, Inc.
Radiology
108d
Cleared
Aug 26, 2025
Brainomix 360 Triage Stroke
Brainomix Limited
Radiology
60d
Cleared
Aug 20, 2025
Methinks CTA Stroke
Methinks Software, S.L
Radiology
89d
Cleared
Jul 16, 2025
Rapid CTA 360
Ischemaview
Radiology
93d
Cleared
Jun 16, 2025
Methinks NCCT Stroke
Methinks Software, S.L
Radiology
102d
Cleared
May 30, 2025
BriefCase-Triage
Aidoc Medical , Ltd.
Radiology
24d
Cleared
Apr 10, 2025
syngo.CT LVO Detection
Siemens Medical Solutions USA, Inc.
Radiology
192d
Cleared
Mar 03, 2025
JLK-SDH
JLK, Inc.
Radiology
101d
Cleared
Feb 20, 2025
EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100)
Ever Fortune.Ai, Co., Ltd.
Radiology
155d
Cleared
Feb 14, 2025
BriefCase-Triage
Aidoc Medical , Ltd.
Radiology
18d
Cleared
Jan 03, 2025
JLK-ICH
JLK, Inc.
Radiology
66d
Cleared
Dec 06, 2024
EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100)
Ever Fortune.Ai, Co., Ltd.
Radiology
158d
Cleared
Nov 07, 2024
NeuroICH
Neurocareai, Inc.
Radiology
146d
About Product Code QAS - Regulatory Context
510(k) Submission Activity
85 total 510(k) submissions under product code QAS since 2018, with 84 receiving FDA clearance (average review time: 118 days).
Submission volume has increased in recent years - 30 submissions in the last 24 months compared to 23 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - QAS Product Code
FDA review times for QAS submissions have been consistent, averaging 115 days recently vs 120 days historically.
QAS devices are reviewed by the Radiology panel. Browse all Radiology devices →