Radiology · 510(k) · 2024
Heuron ICH
Heuron Co., Ltd.. Cleared by FDA on 15 May 2024 under submission K233247, product code QAS (radiological computer-assisted triage and notification software). What FDA's record says, in FDA's words.
Device record · K233247
- Device. Heuron ICHDEVICE
- Company. Heuron Co., Ltd. (KR)COMPANY
- Decision. 15 May 2024, 510(k), substantially equivalent (traditional review); received 28 September 2023DECISION
- Panel. RadiologyPANEL
- Product code. QAS, Radiological Computer-Assisted Triage And Notification SoftwareCODE
- Regulation. 21 CFR 892.2080, Class IIREG
- Source. FDA database entry · decision document (8 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
Heuron ICH is radiological computer-aided triage and notification software designed for the analysis of non- contrast head CT images in adults or transitional adolescents aged 18 and older. This device is intended to 1 aid appropriately trained medical specialists and hospital networks in streamlining workflow by identifying and communicating suspected positive findings of Intracranial hemorrhage (ICH). Heuron ICH employs an artificial in telligence algorithm to analyze non-contrast CT images, flagging cases with identified findings through a dedicated application that operates in parallel with the standard of care image interpretation process. Users receive notificatio ns for cases with suspected findings, which include compressed preview images provided for informational purposes only and are not intended for diagnostic use beyond notification. Importantly, Heuron ICH does not modify the original medical images and is not intended to serve as a diagnostic device. The results generated by Heuron ICH are intended to complement other patient information and assist medical specialists in prioritizing and triaging medica l images. Notified medical specialists are responsible for viewing the full non-contrast CT images in accordance with established standard of care practices.
The product code's definition, from FDA's classification record. 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 .
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedCT
- Mentionstriage or notification
- Mentionsdetection or identification of findings
- Mentionsa diagnostic claim
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code QAS. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code QAS, in Radiology, from Heuron Co., Ltd., or cleared in 2024. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.