Radiology · 510(k) · 2023
Brainomix 360 e-ASPECTS
Brainomix Limited. Cleared by FDA on 23 February 2023 under submission K221564, product code POK (computer-assisted diagnostic software for lesions suspicious for cancer). What FDA's record says, in FDA's words.
Device record · K221564
- Device. Brainomix 360 e-ASPECTSDEVICE
- Company. Brainomix Limited (GB)COMPANY
- Decision. 23 February 2023, 510(k), substantially equivalent (traditional review); received 31 May 2022DECISION
- Panel. RadiologyPANEL
- Product code. POK, Computer-Assisted Diagnostic Software For Lesions Suspicious For CancerCODE
- Regulation. 21 CFR 892.2060, Class IIREG
- Source. FDA database entry · decision document (22 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.
Brainomix 360 e-ASPECTS is a computer-aided diagnosis (CADx) software device used to assist the clinician in the assessment and characterization of brain tissue abnormalities using CT image data. The software automatically registers images and uses an Atlas to segment and analyze ASPECTS regions. Brainomix 360 e-ASPECTS extracts image data from individual voxels in the image to provide analysis and computer analytics and relates the analysis to the atlas defined ASPECTS regions. The imaging features are then synthesized by an artificial intelligence algorithm into a single ASPECTS (Alberta Stroke Program Early CT) Score. Brainomix 360 e-ASPECTS is indicated for evaluation of patients presenting for diagnostic imaging workup with known MCA or ICA occlusion, for evaluation of extent of disease. Extent of disease refers to the number of ASPECTS regions affected which is reflected in the total score. Brainomix 360 e-ASPECTS provides information that may be useful in the characterization of ischemic brain tissue injury during image interpretation (within 6 hours from time last known well). Brainomix 360 e-ASPECTS provides a comparative analysis to the ASPECTS standard of care radiologist assessment by providing highlighted ASPECTS regions and an automated editable ASPECTS score for clinician review. Brainomix 360 e-ASPECTS additionally provides a visualization of the voxels contributing to the automated ASPECTS score and the voxels excluded from the automated ASPECTS score.
The product code's definition, from FDA's classification record. Assist users in characterizing lesions identified on acquired medical images
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
- Mentionsan adjunct to the clinician, not a replacement
- Mentionsmeasurement or quantification
- Mentionsa diagnostic claim
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 1 report filed against devices carrying product code POK. 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. The latest reports, in the reporter’s words:
15 January 2021 · Malfunction · QUANTX · report MW5098869
QUANTX SOFTWARE MAY ENTER INTO AN ERROR STATE IN WHICH MEDICAL IMAGES DISPLAYED TO THE USER ARE FROZEN IN PLACE. QUANTX SOFTWARE VERSION (B)(4) ENTER INTO AN ERROR STATE IN WHICH ONE VIEWPORT IS FROZEN IN PLACE. WHEN THIS ERROR OCCURS, QUANTX STOPS RESPONDING TO USER INPUTS TO MODIFY THE DISPLAY OF THE FROZEN IMAGE. THIS ERROR STATE IS REACHED THROUGH A SPECIFIC SEQUENCE OF KEYSTROKES AND MOUSE ACTIONS. ONCE THE ONE IMAGE IS FROZEN IN A VIEWPORT IT REMAINS FROZEN. IT WILL ALSO REMAIN FROZEN IF […]
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 POK, in Radiology, from Brainomix Limited, 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.