Radiology · 510(k) · 2020
HALO
NICo-Lab B.V.. Cleared by FDA on 20 November 2020 under submission K200873, product code QAS (radiological computer-assisted triage and notification software). What FDA's record says, in FDA's words.
Device record · K200873
- Device. HALODEVICE
- Company. NICo-Lab B.V. (NL)COMPANY
- Decision. 20 November 2020, 510(k), substantially equivalent (traditional review); received 1 April 2020DECISION
- 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.
HALO is a notification only cloud-based image processing software application using artificial intelligence algorithms to analyze patient imaging data in parallel to the standard of care imaging interpretation. Its intended use is to identify suggestive imaging patterns of a pre-specified clinical condition and to directly notify an appropriate medical specialist. HALO’s indication is to facilitate the evaluation of the brain vasculature on patients suspected of stroke by processing and analyzing contrast enhanced CT angiograms of the brain acquired in an acute setting. After completion of the data analysis, HALO sends a notification if a pattern suggestive for a suspected intracranial Large Vessel Occlusion (LVO) of the anterior circulation (ICA, M1 or M2) has been identified in an image. The intended users of HALO are defined as appropriate medical specialists or a team of specialists that are involved in the diagnosis and care of stroke patients at emergency departments or other department where stroke patients are administered. They include physicians such as neurologists, radiologists, and/or other emergency department physicians. HALO’s output should not be used for primary diagnosis or clinical decisions; the final diagnosis is always decided upon by the medical specialist. HALO is indicated for CT scanners from GE Healthcare.
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
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 NICo-Lab B.V., or cleared in 2020. The whole record is at FDA AI-enabled medical devices.
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