Radiology · 510(k) · 2023
Rapid NCCT Stroke
iSchemaView, Inc.. Cleared by FDA on 2 March 2023 under submission K222884, product code QAS (radiological computer-assisted triage and notification software). What FDA's record says, in FDA's words.
Device record · K222884
- Device. Rapid NCCT StrokeDEVICE
- Company. iSchemaView, Inc.COMPANY
- Decision. 2 March 2023, 510(k), substantially equivalent (traditional review); received 22 September 2022DECISION
- 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 (12 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.
Rapid NCCT Stroke is a radiological computer aided triage and notification software indicated for use in the analysis of (1) nonenhanced head CT (NCCT) images. The device is intended to assist hospital networks and trained clinicians in workflow triage by flagging and communicating suspected positive findings of (1) head CT images for Intracranial Hemorrhage (ICH) and (2) NCCT large vessel occlusion (LVO) of the ICA and MCA-M1. Rapid NCCT Stroke uses an artificial intelligence algorithm to analyze images and highlight cases with detected (1) ICH or (2) NCCT LVO on the Rapid server on premise or in the cloud in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected ICH or LVO findings via PACS, email or mobile device. Notifications include compressed preview images that are meant for informational purposes only, and are not intended for diagnostic use beyond notification. The device does not alter the original medical image, and it is not intended to be used as a primary diagnostic device. The results of Rapid NCCT Stroke are intended to be used in conjunction with other patient information and based on professional judgment to assist with triage/prioritization of medical images. Notified clinicians are ultimately responsible for reviewing full images per the standard of care. Rapid NCCT Stroke is for Adults only. Cautions: • All patients should get adequate care for their symptoms including CTA and/or […]
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 iSchemaView, Inc., or cleared in 2023. 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.