Radiology · 510(k) · 2018
Accipiolx
MaxQ-Al Ltd.. Cleared by FDA on 26 October 2018 under submission K182177, product code QAS (radiological computer-assisted triage and notification software). What FDA's record says, in FDA's words.
Device record · K182177
- Device. AccipiolxDEVICE
- Company. MaxQ-Al Ltd. (IL)COMPANY
- Decision. 26 October 2018, 510(k), substantially equivalent (traditional review); received 10 August 2018DECISION
- 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 (6 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.
AccipioIx is a software workflow tool designed to aid in priori tizing the clinical assessment of adult non-contrast head CT cases with features suggestive of acute in tracranial hemorrhage in the acute care environment. AccipioIx analyzes cases using an artificial intelligence algorithm to identify 1 suspected findings. It makes case-level output available to a PACS/workstation for worklist prioritization or triage. AccipioIx is not intended to dir ect attention to specific porti ons of an image or to anomalies other than acute intracranial hemorrhage. Its results are not intended to be used on a stand-alone basis for clinical decision-making nor is it intended to rule out hem orrhage or otherwise preclude clinical assessment of CT cases. AccipioIx and the predicate device (ContaCT) have the same inte nded use and substantially similar indications for use. Both devices are assistive software tools for diagnosis, designed to analyze brain CT images for findings suggestive of a pre-specified clin ical condition -- specifically, cerebrovascular (CV) events. The subject device (AccipioIx) supports the rapid assessment of acute intracranial hemorrhage (aICH), while the predicate device assesses findings potentially indicative of large vessel occlusion (LVO). Since aICH and LVO are aspects of the same differential diagnosis and treatment considerations, the clinical purpose of the two d evices is substantially equivalent; thus, both devices have the same intended use. In […]
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 MaxQ-Al Ltd., or cleared in 2018. 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.