Duns Number:078397649
Device Description: The Imbio CT Lung Density Analysis Software is a set of image post-processing algorithms t The Imbio CT Lung Density Analysis Software is a set of image post-processing algorithms that perform image segmentation, registration, thresholding, and classification on CT images of human lungs.Imbio CT Lung Density Analysis Software is a command-line software application that analyzes DICOM CT lung image datasets and generates reports and DICOM output that show the lungs segmented and overlaid with color-codings representing the results of its thresholding and classification rules. It has simple file management functions for input and output. Imbio CT Lung Density Analysis Software does not interface directly with any CT or data collection equipment; instead the software imports data files previously generated by such equipment.
Catalog Number
-
Brand Name
Imbio LDA
Version/Model Number
4.1.0
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K141069
Product Code
JAK
Product Code Name
System, X-Ray, Tomography, Computed
Public Device Record Key
ada935f7-919e-47df-864b-27b225e4aedc
Public Version Date
September 14, 2022
Public Version Number
1
DI Record Publish Date
September 06, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 24 |