Viz HDS, Viz Volume Plus, Viz ICH+
Viz. ai, inc.
Product Details
Model Identifier
Manufacturer
Viz. ai, inc.
Product
Viz HDS, Viz Volume Plus, Viz ICH+
Version
Unknown
Date Cleared
02/05/2024
FDA Submission No.
Category
MIMPS
Model Characteristics
Inclusion Criteria
Non-contrast head CT scans
Exclusion Criteria
Unknown
Instructions for Use
Not available
Indications for Use
Indication of Use
The Viz HDS device is intended for automatic labeling, visualization, and quantification of segmentable brain structures
from a set of Non-Contrast CT (NCCT) head scans. The software is intended to automate the current manual process of
identifying, labeling, and quantifying the volume of segmentable brain structures identified on NCCT images. Viz HDS
provides volumes from NCCT scans acquired at a single time point. The Viz HDS software is indicated for use in the
analysis of the following structures: Intracranial Hyperdensities, Lateral Ventricles and Midline Shift. The device output
should be reviewed along with patient’s original images by a physician.
Type of
Intended User
Radiologist
Age
Unknown
Anatomy
Head
Modality
CT
Output
Outline intracranial
hyperdensity areas, lateral ventricles (right and left), midline shift, and then quantify the volume
of intracranial hyperdensity(ies), volume of lateral ventricles, lateral ventricle asymmetry ratio
and distance of midline shift
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
Unknown
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
Unknown
Model Sensitivity
Not provided
Model Specificity
Not provided
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)
Contact Information
Contact Information
Point of Contact Name
Unknown
Email
Unknown
Additional Details
Related Use Cases
Unknown