Radiology · 510(k) · 2025
StrokeSENS ASPECTS Software Application
Circle Cardiovascular Imaging Inc.. Cleared by FDA on 1 July 2025 under submission K250221, product code POK (computer-assisted diagnostic software for lesions suspicious for cancer). What FDA's record says, in FDA's words.
Device record · K250221
- Device. StrokeSENS ASPECTS Software ApplicationDEVICE
- Company. Circle Cardiovascular Imaging Inc. (CA)COMPANY
- Decision. 1 July 2025, 510(k), substantially equivalent (traditional review); received 24 January 2025DECISION
- 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 (15 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.
StrokeSENS 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. StrokeSENS 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 ASPECT (Alberta Stroke Program Early CT) Score. StrokeSENS 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. StrokeSENS ASPECTS provides information that may be useful in the characterization of ischemic brain tissue injury during image interpretation (within 12 hours from time last known well). StrokeSENS 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. StrokeSENS ASPECTS presents the original and annotated images for concurrent reads. StrokeSENS ASPECTS additionally provides a visualization of the voxels contributing to 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 Circle Cardiovascular Imaging Inc., or cleared in 2025. 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.