Duns Number:656738726
Device Description: AmCAD UT Detection is a Windows computer aided detection device intended to assist the med AmCAD UT Detection is a Windows computer aided detection device intended to assist the medical professionals in analyzing thyroid ultrasound images, acquired from FDA cleared ultrasound systems, with user selected regions of interest. After the initial review of the ultrasound images by the physicians, the device further provides detailed information with quantification and visualization of sonographic characteristics of thyroid nodules. The device is intended for use on ultrasound images of discrete thyroid nodules larger than 1cm, for which a biopsy recommendation is required.
Catalog Number
UT-0222-KOL
Brand Name
AmCAD UT Detection
Version/Model Number
2.2
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K180006,K180006
Product Code
LLZ
Product Code Name
System, Image Processing, Radiological
Public Device Record Key
7c6f7a5f-3fbb-4f8b-8413-491bb28ad44d
Public Version Date
August 08, 2019
Public Version Number
1
DI Record Publish Date
July 31, 2019
Package DI Number
14719875621113
Quantity per Package
5
Contains DI Package
04719875621116
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |