qXR-BT
Qure.ai Technologies
Product Details
Model Identifier
Manufacturer
Qure.ai Technologies
Product
qXR-BT
Version
Unspecified
Date Cleared
12/21/2021
FDA Submission No.
Category
MIMPS
Model Characteristics
Inclusion Criteria
for Chest Xrays, for adult population only
Exclusion Criteria
Scans of any other anatomy or from other modalities
Instructions for Use
Not available
Indications for Use
Indication of Use
The qXR-BT device is intended to generate a secondary digital chest X-ray image that facilitates confirmation of the position of a breathing tube and an anatomical landmark on adult chest Xrays. This device is intended for use by licensed physicians who are trained in the evaluation of breathing tube placement on chest X-rays. The qXR-BT image provides adjunctive information and is not a substitute for the original PA/AP image.
Intended User
Radiologists, Physicians
Age
Unknown
Anatomy
Chest
Modality
XRAY
Output
Breathing Tube
Details on Training Data Sets
Details on Training Data Sets
No. of Cases
Unspecified
Age Range (Years)
Unspecified
Sex (%)
- Female: Unspecified
- Male: Unspecified
- Unknown: Unspecified
Output
Unspecified
Race (%)
- White: Unspecified
- Black or African American: Unspecified
- American Indian or Alaska Native: Unspecified
- Asian: Unspecified
- Native Hawaiian or Other Pacific Islander: Unspecified
- Unknown: Unspecified
Ethnicity (%)
- Hispanic or Latino: Unspecified
- Not Hispanic or Latino: Unspecified
- Unknown: Unspecified
Geographic Region (%)
- USA: Unspecified
- International: Unspecified
- Unknown: Unspecified
Scanner Manufacturer(s)
Unspecified
Scanner Model(s)
Unspecified
Model Performance
Study Type
Performance Testing Type
Stand-Alone Performance
Standalone Model Performance
Reference Standard (Ground Truth)
Unspecified
No. of Cases
Unspecified
Age Range (Years)
Unspecified
Sex (%)
- Female: Unspecified
- Male: Unspecified
- Unknown: Unspecified
Race (%)
- White: Unspecified
- Black or African American: Unspecified
- American Indian or Alaska Native: Unspecified
- Asian: Unspecified
- Native Hawaiian or Other Pacific Islander: Unspecified
- Unknown: Unspecified
Ethnicity (%)
- Hispanic or Latino: Unspecified
- Not Hispanic or Latino: Unspecified
- Unknown: Unspecified
Geographic Region (%)
- USA: Unspecified
- International: Unspecified
- Unknown: Unspecified
Output
Unspecified
Scanner Manufacturer(s)
Samsung;Carestream;Konica Minolta
Scanner Model(s)
DRX-1;DRX-Revolution
No. of Sites
Unspecified
Model Accuracy
Unspecified
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)
Unspecified
Slice Thickness
Unspecified
Contrast Use
Unspecified
MRI Field Strength
Unspecified
Reconstruction Kernel Used
Unspecified
Alternative Choices
Alternative Choices
Previous Version(s)
Unspecified
Predicate Device(s)
Contact Information
Contact Information
Point of Contact Name
Unspecified
Email
Unspecified
Additional Details
Related Use Cases
Unspecified