What is FDA product code QAS?

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 .

Radiology › Image Processing and StorageRadiological Computer-Assisted Triage And Notification Software

StrokeSENS

Name: StrokeSENS
Brand: StrokeSENS

StrokeSENS LVO is software intended to assist hospital networks and trained clinicians with workflow triage by flagging suspected large-vessel occlusion findings in head CTA images. After a…

Registry build 21.09.26

StrokeSENS LVO is software intended to assist hospital networks and trained clinicians with workflow triage by flagging suspected large-vessel occlusion findings in head CTA images.

After a CTA head scan, the system processes and analyzes the images, then can display an on-screen notice and send an outbound notification to a neurovascular specialist. The notice indicates a suspected finding.

Listed Item

StrokeSENS LVO is a radiological computer-aided triage and notification software indicated for use in the analysis of CTA head images. The device is intended to assist hospital networks and trained clinicians in workflow triage by flagging and communication of suspected positive findings of Large Vessel Occlusion (LVO) in head CTA images.

System Components

The filing describes a DICOM-compliant system with a processing engine and compatible radiological software platform. The processing engine receives, analyzes and communicates image information.

1manufacturer

1catalogue number

1510(k) clearance

Who Else Makes It

Registered in Beijing.

Chinese manufacturers registered for FDA product code QAS
Manufacturer	City	Province	Registered as	Device types
Beijing Infervision Healthcare Medical Technology Co., Ltd.	Beijing	Beijing	Complaint-file establishment	4

Record

Regulatory record for StrokeSENS
Listed by	Circle Neurovascular Imaging, Inc., Canada
FDA product code	QAS
Device type	Radiological Computer-Assisted Triage And Notification Software
Device class	Class 2
Regulation	21 CFR 892.2080
510(k)	K212261
Record published	2022-08-30

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for StrokeSENS
Catalogue number	Size	Status
v1.x		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Viz LVO	Viz.ai, Inc.	12
Triage Stroke	Brainomix Limited	5
BriefCase Triage	Aidoc Medical Ltd.	5
Triage LVO	Brainomix Limited	5
BriefCase	Aidoc Medical Ltd.	3
HealthICH	Nano-X AI Ltd.	3
Annalise Triage	Harrison-AI Medical Pty Ltd	3
Triage ICH	Brainomix Limited	3
syngo.CT Brain Hemorrhage	Siemens Healthcare Limited	2
AccipioIx	Maxq AI Ltd	2
Viz ICH	Viz.ai, Inc.	2
qER	Qure.ai Technologies Private Limited	1

Showing 12 of 29. All products under Radiological Computer-Assisted Triage And Notification Software

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K212261	2021-10-14

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.