Rapid Aortic Measurements
RapidAI
Product Details
Model Identifier
Manufacturer
RapidAI
Product
Rapid Aortic Measurements
Version
Unknown
Date Cleared
09/23/2025
FDA Submission No.
Category
MIMPS
Model Characteristics
Inclusion Criteria
CT imaging datasets of the chest, abdomen, and/or pelvis
Exclusion Criteria
Series acquired w/cone-beam CT scanners (c-arm CT), Series that are non-axial or axial oblique greater than 5 degrees, Series containing improperly ordered or missing slices where the gap is larger than 3 times the median inter-slice distance, Series with less than 3cm of target anatomical zones, NCCT, CECT, CTA, or CTPA datasets with specific technical limitations
Instructions for Use
Not available
Indications for Use
Indication of Use
Rapid Aortic Measurements (AM) is an image analysis and measurement device to evaluate aortic and iliac arteries in contrast enhanced and non-contrast CT imaging datasets acquired of the chest, abdomen, and/or pelvis. The module segments the aorta, iliacs, and major branching vessels and provides 2D and 3D visualizations of the segmented vessels.
Outputs of the device include: Centerline measurements of the aorta and iliacs, Aortic Zone Measurements (Maximum Oblique Diameter), Fixed Measurements of the aorta and left and right iliacs, 3D Volume Renderings, Rotations, Curved Planar Reformations (CPRs) of the isolated left and right iliacs, aortic oblique Multiplanar Reconstructions (MPRs), and Longitudinal Tracking visualizations.
Rapid Aortic Measurements is an aid to physician decision making. Its results are not intended to be used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment.
Rapid Aortic Measurements is indicated for adults.
Intended User
Radiologists, cardiothoracic surgeons, vascular surgeons, endovascular specialists, ED physicians, or users with similar training
Age
Adult
Anatomy
Abdomen, Chest, Pelvis
Modality
CT
Output
Centerline measurements of aorta and iliacs, aortic zone measurements, fixed measurements, 3D visualizations, curved planar reformations, multiplanar reconstructions, and longitudinal tracking visualizations
Details on Training Data Sets
Details on Training Data Sets
No. of Cases
Unknown
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)
Unknown
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
108
Age Range (Years)
22 - 90
Sex (%)
Female: 33
Male: 61
Unknown: 6
Male: 61
Unknown: 6
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: 50
International: 22
Unknown: 28
International: 22
Unknown: 28
Output
Unknown
Scanner Manufacturer(s)
Canon\Toshiba;GE;Philips;Siemens
Scanner Model(s)
Unknown
No. of Sites
Unknown
Model Accuracy
Unknown
Model Sensitivity
Unknown
Model Specificity
Unknown
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