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

syngo.CT Brain Hemorrhage

Name: syngo.CT Brain Hemorrhage
Brand: syngo.CT Brain Hemorrhage

2 catalogue numbers from 11546320, listed by Siemens Healthcare Limited, Canada, under Radiological Computer-Assisted Triage And Notification Software. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

2catalogue numbers in this listing

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 syngo.CT Brain Hemorrhage
Listed by	Siemens Healthcare Limited, Canada
FDA product code	QAS
Device type	Radiological Computer-Assisted Triage And Notification Software
Device class	Class 2
Regulation	21 CFR 892.2080
Establishment	Contract manufacturer, Manufacturer, Exporter
510(k)	K203260
Record published	2022-11-30
Record revised	2023-12-20 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	serial number

Catalogue Numbers

Catalogue numbers for syngo.CT Brain Hemorrhage
Catalogue number	Size	Status
11546320		In distribution
11664620		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
AccipioIx	Maxq AI Ltd	2
Viz ICH	Viz.ai, Inc.	2
qER	Qure.ai Technologies Private Limited	1
Viz SDH (Viz Subdural)	Viz.ai, Inc.	1

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

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.