SwiftMR

AIRS Medical Inc.
SwiftMR Model Card
Product Details
Model Identifier
Manufacturer
AIRS Medical Inc.
Product
SwiftMR
Version
3
Date Cleared
10/27/2023
FDA Submission No.
Category
MIMPS
Model Characteristics
Inclusion Criteria
MR images from all body parts in DICOM format
Exclusion Criteria
Medical images from other modalities; MR images in formats other than that of DICOM format
Instructions for Use
Not available
Indications for Use
Indication of Use
SwiftMR is a stand-alone software solution intended to be used for acceptance, enhancement and transfer of all body parts MR images in DICOM format. It can be used for noise reduction and increasing image sharpness for MR images. SwiftMR is not intended for use on mobile devices.
Intended User
Radiology technologist
Age
Adult and Pediatric
Anatomy
Whole Body
Modality
MR
Output
Image Quality Improvement
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
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
3
No. of Cases
398
No. of Sites
Unspecified
Output
Unspecified
Age Range (Years)
0 - 93
Sex (%)
Male: 44
Race (%)
Asian: 20
Unknown: 80
Ethnicity (%)
Not Hispanic or Latino: 20
Unknown: 80
Geographic Region (%)
USA: 60
International: 39
Scanner Manufacturer(s)
Canon\Toshiba;Fujifilm;GE;Philips;Siemens;Other
Scanner Model(s)
Achieva;Discovery 750;Ingenia;Magnetom Avanto;Magnetom Essenza;Magnetom Prisma;Magnetom Skyra;Magnetom Vida;Signa;Signa Explorer;Vantage Elan
Model Accuracy
Not applicable
Model Sensitivity
Not applicable
Model Specificity
Not applicable
Model Limitations, Warnings, & Precautions
Model Limitations, Warnings, & Precautions
Supported Scanner Manufacturer(s)
Unspecified
Slice Thickness
Unspecified
Contrast Use
Without and with contrast
MRI Field Strength
Unspecified
Reconstruction Kernel Used
Not Applicable
Alternative Choices
Alternative Choices
Previous Version(s)
Unspecified
Contact Information
Contact Information
Point of Contact Name
Unspecified
Email
Unspecified
Additional Details
Related Use Cases
Unspecified
All Products And Platforms from AIRS Medical Inc.