Radiology · 510(k) · 2024
Hyper Insight - ICH
SK Inc.. Cleared by FDA on 1 July 2024 under submission K240353, product code QAS (radiological computer-assisted triage and notification software). What FDA's record says, in FDA's words.
Device record · K240353
- Device. Hyper Insight - ICHDEVICE
- Company. SK Inc. (KR)COMPANY
- Decision. 1 July 2024, 510(k), substantially equivalent (traditional review); received 5 February 2024DECISION
- 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 (10 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.
Hyper Insight - ICH is a notification-only workflow tool for trained clinicians to identify patients' brain CT images and share them with medical specialists in parallel with standard patient care workflow. Hyper Insight - ICH uses deep learning-based Al algorithms to analyze images to find suspected intracranial hemorrhage and notifies and shares the findings to medical specialists. Identification of images with suspected intracranial hemorrhage is for notification purposes only, not diagnostic purposes. In particular, this medical device analyzes non-contrast brain CT images, and if a suspected intracranial hemorrhage is identified, it sends a notification to medical specialists, who are advised to review these images. Images may be previewed through the mobile app but are for informational purposes only and are not intended to be used for diagnostic purposes other than notifications and previews. The medical specialist who received the notification is responsible for reading the image in a diagnostic viewer. Hyper Insight - ICH is limited to the purpose of analysis of image data and should not be used as a substitute for a full patient assessment or relied upon to make or confirm a diagnosis.
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
- Mentionsan adjunct to the clinician, not a replacement
- Mentionstriage or notification
- Mentionsdetection or identification of findings
- Mentionsa diagnostic claim
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, 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.