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
85 devices
Cleared
Jun 17, 2020
qER
Qure.Ai Technologies
Radiology
72d
Cleared
Apr 21, 2020
NinesAI
Nines, Inc.
Radiology
140d
Cleared
Apr 13, 2020
CuraRad-ICH
Curacloud Corp.
Radiology
248d
Cleared
Mar 31, 2020
Rapid ICH
Ischemaview Incorporated
Radiology
146d
Cleared
Mar 18, 2020
Viz ICH
Viz. Ai, Inc.
Radiology
79d
Cleared
Dec 20, 2019
BriefCase
Aidoc Medical , Ltd.
Radiology
112d
Cleared
Jul 10, 2019
DeepCT
Deep01 Limited
Radiology
271d
Cleared
Jun 13, 2019
HealthICH
Zebra Medical Vision, Ltd.
Radiology
111d
Cleared
May 31, 2019
BriefCase
Aidoc Medical , Ltd.
Radiology
56d
Cleared
Apr 15, 2019
BriefCase
Aidoc Medical , Ltd.
Radiology
90d
Cleared
Oct 26, 2018
Accipiolx
Maxq-Al , Ltd.
Radiology
77d
Cleared
Aug 01, 2018
BriefCase
Aidoc Medical , Ltd.
Radiology
142d
Not Cleared
Feb 13, 2018
ContaCT
Viz.Al, Inc.
Radiology
137d