Duns Number:195621060
Device Description: LungPrint is an interactive software-based viewing and reporting platform that displays im LungPrint is an interactive software-based viewing and reporting platform that displays image analysis results for use by pulmonary care providers in the diagnosis and documentation of pulmonary tissue images.
Catalog Number
-
Brand Name
LungPrint
Version/Model Number
1.x
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
K083227
Product Code
JAK
Product Code Name
System, X-Ray, Tomography, Computed
Public Device Record Key
2e6ec66e-8fef-4e55-b49f-e17de87ad4de
Public Version Date
April 22, 2020
Public Version Number
1
DI Record Publish Date
April 14, 2020
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. | 3 |