Radiology · 510(k) · 2022
BriefCase
Aidoc Medical, Ltd.. Cleared by FDA on 26 April 2022 under submission K213886, product code QAS (radiological computer-assisted triage and notification software). What FDA's record says, in FDA's words.
Device record · K213886
- Device. BriefCaseDEVICE
- Company. Aidoc Medical, Ltd. (IL)COMPANY
- Decision. 26 April 2022, 510(k), substantially equivalent (traditional review); received 13 December 2021DECISION
- 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.
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of contrast-enhanced chest CTs (not dedicated CTPA protocol) in adults or transitional adolescents age 18 and older. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of suspect cases of incidental Pulmonary Embolism (iPE) pathologies. The device is intended to be used on single - energy exams only. BriefCase uses an artificial intelligence algorithm to analyze images and flag suspect cases on a standalone desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for suspect cases. 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 t o be used as a diagnostic device. The results of BriefCase are intended to be used in conjunction with other patient information and based on their professional judgment, to assist with triage/prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care.
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.
- Mentionstriage or notification
- 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 Aidoc Medical, Ltd., or cleared in 2022. 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.