Rapid CTA 360

RapidAI
Rapid CTA 360 Model Card
Product Details
Model Identifier
Manufacturer
RapidAI
Product
Rapid CTA 360
Version
Unknown
Date Cleared
07/16/2025
FDA Submission No.
Category
CADt
Model Characteristics
Inclusion Criteria
CTA adult head images
Exclusion Criteria
Unknown
Instructions for Use
Not available
Indications for Use
Indication of Use
Rapid CTA 360 is a radiological computer aided triage and notification software indicated for use in the analysis of CTA adult head images. The device is intended to assist hospital networks and trained clinicians in workflow triage by flagging and communication of suspected positive Large and Medium Vessel Occlusion findings in head CTA images including the ICA (C1-C5), MCA (M1-M3), ACA, PCA, Basilar and Vertebral vascular segments. Rapid CTA 360 uses an AI software algorithm to analyze images and highlight cases with suspected occlusion on a server or standalone desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected LVO and MVO findings. Notifications include compressed preview images. These are meant for informational purposes only and are not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device. The results of Rapid CTA 360 are intended to be used in conjunction with other patient information and based on professional judgment, to assist with triage/prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care.
Intended User
Hospital networks and trained clinicians
Age
Adult
Anatomy
Head
Modality
CTA
Output
The device flags and communicates suspected positive Large and Medium Vessel Occlusion findings in head CTA images, including the ICA (C1-C5), MCA (M1-M3), ACA, PCA, Basilar and Vertebral vascular segments. It provides notifications with compressed preview images for cases with suspected LVO and MVO findings.
Details on Training Data Sets
Details on Training Data Sets
No. of Cases
6,264
Age Range (Years)
Unknown
Sex (%)
  • Female: Unknown
  • Male: Unknown
  • Unknown: Unknown
Output
Unknown
Race (%)
  • White: Unknown
  • Black or African American: Unknown
  • American Indian or Alaska Native: Unknown
  • Asian: Unknown
  • Native Hawaiian or Other Pacific Islander: Unknown
  • Unknown: Unknown
Ethnicity (%)
  • Hispanic or Latino: Unknown
  • Not Hispanic or Latino: Unknown
  • Unknown: Unknown
Geographic Region (%)
  • USA: Unknown
  • International: Unknown
  • Unknown: Unknown
Scanner Manufacturer(s)
Canon\Toshiba;GE;Philips;Siemens
Scanner Model(s)
Unknown
Model Performance
Study Type
Performance Testing Type
Stand-Alone Performance
Standalone Model Performance
Reference Standard (Ground Truth)
Unknown
No. of Cases
403
Age Range (Years)
22 - 90
Sex (%)
Female: 47
Male: 51
Unknown: 2
Race (%)
  • White: Unknown
  • Black or African American: Unknown
  • American Indian or Alaska Native: Unknown
  • Asian: Unknown
  • Native Hawaiian or Other Pacific Islander: Unknown
  • Unknown: Unknown
Ethnicity (%)
  • Hispanic or Latino: Unknown
  • Not Hispanic or Latino: Unknown
  • Unknown: Unknown
Geographic Region (%)
  • USA: Unknown
  • International: Unknown
  • Unknown: Unknown
Output
Unknown
Scanner Manufacturer(s)
Canon\Toshiba;GE;Philips;Siemens
Scanner Model(s)
Unknown
No. of Sites
Unknown
Model Accuracy
Unknown
Model Sensitivity
92
Model Specificity
89% (95% CI: 83
Reader Study Performance
No. of Readers
N/A
No. of Cases
N/A
No. of Sites
N/A
Output
N/A
Age Range (Years)
N/A
Sex (%)
  • Female: N/A
  • Male: N/A
  • Unknown: N/A
Race (%)
  • White: N/A
  • Black or African American: N/A
  • American Indian or Alaska Native: N/A
  • Asian: N/A
  • Native Hawaiian or Other Pacific Islander: N/A
  • Unknown: N/A
Ethnicity (%)
  • Hispanic or Latino: N/A
  • Not Hispanic or Latino: N/A
  • Unknown: N/A
Geographic Region (%)
  • USA: N/A
  • International: N/A
  • Unknown: N/A
Scanner Manufacturer(s)
N/A
Scanner Model(s)
N/A
Model Accuracy
N/A
Model Sensitivity
N/A
Model Specificity
N/A
Model Limitations, Warnings, & Precautions
Model Limitations, Warnings, & Precautions
Supported Scanner Manufacturer(s)
Unknown
Slice Thickness
Unknown
Contrast Use
Unknown
MRI Field Strength
Unknown
Reconstruction Kernel Used
Unknown
Alternative Choices
Alternative Choices
Previous Version(s)
Unknown
Predicate Device(s)
Unknown
Contact Information
Contact Information
Point of Contact Name
Unknown
Email
Unknown
Additional Details
Related Use Cases
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