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

Heuron ICH

Name: Heuron ICH
Brand: Heuron ICH

Heuron ICH is software that flags suspected intracranial hemorrhage on noncontrast head CT scans to help prioritize review. It is intended for patients aged 18 and older and runs alongside…

Registry build 21.09.26

Heuron ICH is software that flags suspected intracranial hemorrhage on noncontrast head CT scans to help prioritize review. It is intended for patients aged 18 and older and runs alongside the standard image interpretation workflow.

The software receives DICOM studies from registered hospital PACS systems and analyzes them with a deep learning algorithm. Suspected positive cases trigger notifications to medical specialists through configured messaging or application channels.

Notification Limits

Notifications include compressed preview images for information only, not diagnostic interpretation. The software does not provide segmentation or intermediate analysis outputs to users. Clinicians review the original imaging within the standard care process.

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 Heuron ICH
Listed by	Heuron Co., Ltd., South Korea
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)	K233247
Record published	2024-06-24

Specifications

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

Catalogue Numbers

Catalogue numbers for Heuron ICH
Catalogue number	Size	Status
ST-ICT01		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
K233247	2024-05-15

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.