Duns Number:078397649
Device Description: The Imbio CT Lung Density Analysis Software is a set of image post-processing algorithms t
Catalog Number
-
Brand Name
Imbio LDA
Version/Model Number
2.5.2
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)
-
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
810ededa-324b-4628-a0e7-5cc53597c9d0
Public Version Date
October 07, 2019
Public Version Number
2
DI Record Publish Date
January 07, 2019
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 |