Spine Auto Views

GE HealthCare
Spine Auto Views Model Card
Product Details
Model Identifier
Manufacturer
GE HealthCare
Product
Spine Auto Views
Version
Unknown
Date Cleared
07/13/2023
FDA Submission No.
Category
MIMPS
Model Characteristics
Inclusion Criteria
CT spine
Exclusion Criteria
Unknown
Instructions for Use
Not available
Indications for Use
Indication of Use
Spine Auto Views is a non-invasive image analysis software package which may be used in conjunction with CT images to aid in the automatic generation of anatomically focused multi-planar reformats and automatically export results to predetermined DICOM destinations. Spine Auto Views assists clinicians by providing anatomically focused reformats of the spine, with the ability to apply anatomical labels of the vertebral bodies and intervertebral disc spaces. Spine Auto Views may be used for multiple care areas and is not specific to any disease state. It can be utilized for the review of various types of exams including trauma, oncology, and routine body.
Intended User
Clinicians
Age
Unknown
Anatomy
Spine
Modality
CT
Output
Generates oblique axial reformats, appropriately angled through each disc space without the need for a user interface and human interaction. 3D curved coronal and curved sagittal views of the spine as well as traditional reformat planes can all be generated with Spine Auto Views, no manual interaction required. Vertebral bodies and disc spaces can be labeled, and all series networked to desired DICOM destination(s), ready to read. The automated reformats may help in providing a consistent output of anatomically orientated images, labeled, and presented to the interpreting physician ready to read.
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
Reader Study
Standalone Model Performance
Reference Standard (Ground Truth)
N/A
No. of Cases
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
Output
N/A
Scanner Manufacturer(s)
N/A
Scanner Model(s)
N/A
No. of Sites
N/A
Model Accuracy
N/A
Model Sensitivity
N/A
Model Specificity
N/A
Reader Study Performance
No. of Readers
Unknown
No. of Cases
Unknown
No. of Sites
Unknown
Output
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
Scanner Manufacturer(s)
Unknown
Scanner Model(s)
Unknown
Model Accuracy
Unknown
Model Sensitivity
Not provided
Model Specificity
Not provided
Model Limitations, Warnings, & Precautions
Model Limitations, Warnings, & Precautions
Supported Scanner Manufacturer(s)
All
Slice Thickness
Unknown
Contrast Use
Unknown
MRI Field Strength
Unknown
Reconstruction Kernel Used
Unknown
Alternative Choices
Alternative Choices
Previous Version(s)
Unknown
Contact Information
Contact Information
Point of Contact Name
Unknown
Email
Unknown
Additional Details
Related Use Cases
Unknown
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