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

StrokeViewer LVO Triaging

Name: StrokeViewer LVO Triaging
Brand: StrokeViewer LVO Triaging

StrokeViewer LVO Triaging is a notification only cloud-based image processing software application using artificial intelligence algorithms to analyze patient imaging data in parallel to…

Registry build 21.09.26

StrokeViewer LVO Triaging is a notification only cloud-based image processing software application using artificial intelligence algorithms to analyze patient imaging data in parallel to the standard of care imaging interpretation.

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 StrokeViewer LVO Triaging
Listed by	NICo-Lab B.V., Netherlands
FDA product code	QAS
Device type	Radiological Computer-Assisted Triage And Notification Software
Device class	Class 2
Regulation	21 CFR 892.2080
Establishment	Manufacturer
510(k)	K200873
Record published	2022-03-08
Record revised	2022-05-12 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	lot or batch number

Catalogue Numbers

Catalogue numbers for StrokeViewer LVO Triaging
Catalogue number	Size	Status
3		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
K200873	2020-11-20

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.