Duns Number:117164757
Device Description: Computer assisted reading tools designed to aid the radiologist in the detection of pulmon Computer assisted reading tools designed to aid the radiologist in the detection of pulmonary nodules during review of CT examinations of the chest.
Catalog Number
-
Brand Name
InferRead Lung CT.AI 2.1.2.1
Version/Model Number
2.1.2.1
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
K192880
Product Code
LLZ
Product Code Name
System, Image Processing, Radiological
Public Device Record Key
87b9f6e9-e775-4d29-931d-304db22c76fa
Public Version Date
August 18, 2021
Public Version Number
2
DI Record Publish Date
March 23, 2021
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. | 2 |