Rapid DeltaFuse
RapidAI
Product Details
Model Identifier
Manufacturer
RapidAI
Product
Rapid DeltaFuse
Version
Unknown
Date Cleared
08/26/2025
FDA Submission No.
Category
MIMPS
Model Characteristics
Inclusion Criteria
Non-Contrast CT (NCCT) images
Exclusion Criteria
Unknown
Instructions for Use
Not available
Indications for Use
Indication of Use
Rapid DeltaFuse is an image processing software package to be used by trained professionals, including but not limited to physicians and medical technicians. The software runs on a standard off-the-shelf computer or a virtual platform, such as VMware, and can be used to perform image viewing, processing, and analysis of images. Data and images are acquired through DICOM compliant imaging devices. Rapid DeltaFuse provides both viewing and analysis capabilities for imaging datasets acquired with Non-Contrast CT (NCCT) images. The CT analysis includes NCCT maps showing areas of hypodense and hyperdense tissue including overlays of time differentiated scans of the same patient. Rapid DeltaFuse is intended for use for adults.
Intended User
Trained professionals, including but not limited to physicians and medical technicians
Age
Adult
Anatomy
Head
Modality
CT
Output
The device outputs NCCT maps showing areas of hypodense and hyperdense tissue including overlays of time differentiated scans of the same patient.
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
14
Age Range (Years)
Unknown
Sex (%)
- Female: Unknown
- Male: Unknown
- Unknown: 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
Output
Unknown
Scanner Manufacturer(s)
Unknown
Scanner Model(s)
Unknown
No. of Sites
Unknown
Model Accuracy
94% (95% CI: 93%, Unspecified)
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
Additional Details
Related Use Cases
Unknown