QAS · Class II · 21 CFR 892.2080

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..

87
Total
86
Cleared
118d
Avg days
2018
Since
Stable submission activity - 28 submissions in the last 2 years
Consistent review times: 116d avg (recent)

FDA 510(k) Cleared Radiological Computer-assisted Triage And Notification Software Devices (Product Code QAS)

87 devices
1–24 of 87
Cleared Jul 13, 2026
Rapid Vessel Occlusion (Rapid VO)
K261085
Ischemaview
Radiology · 103d
Cleared Jun 18, 2026
Vascular Assist Occlusion Triage (VAOT) (v1.0)
K260729
GuideAI Health
Radiology · 104d
Cleared May 14, 2026
BriefCase-Triage
K261317
Aidoc Medical , Ltd.
Radiology · 23d
Cleared Apr 22, 2026
EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100)
K253163
Ever Fortune.Ai, Co., Ltd.
Radiology · 208d
Cleared Mar 24, 2026
JLK-NCCT
K252421
JLK, Inc.
Radiology · 235d
Cleared Mar 03, 2026
Annalise Enterprise
K253818
Harrison-AI Medical Pty, Ltd.
Radiology · 95d
Cleared Feb 26, 2026
BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax
K253578
Aidoc Medical , Ltd.
Radiology · 101d
Cleared Jan 27, 2026
BriefCase-Triage
K251195
Aidoc Medical , Ltd.
Radiology · 285d
Cleared Jan 07, 2026
BriefCase-Triage: CARE Multi-triage CT Body
K252970
Aidoc Medical , Ltd.
Radiology · 112d
Cleared Nov 25, 2025
Scaida BrainCT-ICH (v1.0)
K250694
Mlhealth 360
Radiology · 263d
Cleared Nov 24, 2025
a2z-Unified-Triage
K252366
A2z Radiology Ai, Inc.
Radiology · 117d
Cleared Nov 06, 2025
BriefCase-Triage
K253265
Aidoc Medical , Ltd.
Radiology · 38d
Cleared Sep 08, 2025
qER-CTA (v1.0)
K251610
Qure.Ai Technologies
Radiology · 104d
Cleared Sep 04, 2025
Rapid Obstructive Hydrocephalus, Rapid OH
K251533
Ischemaview, Inc.
Radiology · 108d
Cleared Aug 26, 2025
Brainomix 360 Triage Stroke
K251983
Brainomix Limited
Radiology · 60d
Cleared Aug 20, 2025
Methinks CTA Stroke
K251590
Methinks Software, S.L
Radiology · 89d
Cleared Jul 16, 2025
Rapid CTA 360
K251151
Ischemaview
Radiology · 93d
Cleared Jun 16, 2025
Methinks NCCT Stroke
K250685
Methinks Software, S.L
Radiology · 102d
Cleared May 30, 2025
BriefCase-Triage
K251406
Aidoc Medical , Ltd.
Radiology · 24d
Cleared Apr 10, 2025
syngo.CT LVO Detection
K243145
Siemens Medical Solutions USA, Inc.
Radiology · 192d
Cleared Mar 03, 2025
JLK-SDH
K243611
JLK, Inc.
Radiology · 101d
Cleared Feb 20, 2025
EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100)
K242821
Ever Fortune.Ai, Co., Ltd.
Radiology · 155d
Cleared Feb 14, 2025
BriefCase-Triage
K250248
Aidoc Medical , Ltd.
Radiology · 18d
Cleared Jan 03, 2025
JLK-ICH
K243363
JLK, Inc.
Radiology · 66d

About Product Code QAS - Regulatory Context

510(k) Submission Activity

87 total 510(k) submissions under product code QAS since 2018, with 86 receiving FDA clearance (average review time: 118 days).

Submission volume has remained relatively stable over the observed period, with 28 submissions in the last 24 months.

FDA 510(k) Review Time - QAS Product Code

FDA review times for QAS submissions have been consistent, averaging 116 days recently vs 119 days historically.

QAS devices are reviewed by the Radiology panel. Browse all Radiology devices →