Radiology · 510(k) · 2021
uAI EasyTriage-Rib
Shanghai United Imaging Intelligence Co., Ltd.. Cleared by FDA on 15 January 2021 under submission K193271, product code QFM (radiological computer-assisted prioritization software for lesions). What FDA's record says, in FDA's words.
Device record · K193271
- Device. uAI EasyTriage-RibDEVICE
- Company. Shanghai United Imaging Intelligence Co., Ltd. (CN)COMPANY
- Decision. 15 January 2021, 510(k), substantially equivalent (traditional review); received 26 November 2019DECISION
- Panel. RadiologyPANEL
- Product code. QFM, Radiological Computer-Assisted Prioritization Software For LesionsCODE
- 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.
uAI EasyTriage-Rib is a radiological computer-assisted triage and notification software device for analysis of CT chest images. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and prioritizing trauma studies with suspected positive findings of multiple (3 or more) acute rib fracture(s). uAI EasyTriage-Rib uses an artificial intelligence algorithm to analyze images and highlight studies with suspected multiple (3 or more) acute rib fracture(s) in a standalone application for study list prioritization or triage in parallel to ongoing standard of care. The user is presented with notifications of cases with suspected findings. Notifications include compressed preview images that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device. The results of uAI EasyTriage-Rib, in conjunction with other clinical information and professional judgment, are to be used to assist with triage/prioritization of medical images. Notified radiologists who read the original medical images are responsible for the diagnostic decision.
The product code's definition, from FDA's classification record. Radiological computer-assisted prioritization software for lesions 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
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code QFM. 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 QFM, in Radiology, from Shanghai United Imaging Intelligence Co., Ltd., or cleared in 2021. 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.