Duns Number:136977290
Device Description: Contour ProtégéAI is an accessory to MIM software that automatically creates contours on m Contour ProtégéAI is an accessory to MIM software that automatically creates contours on medical images through the use of machine-learning algorithms. It is designed for use in the processing of medical images and operates on Windows, Mac, and Linux computer systems. Contour ProtégéAI is deployed on a remote server using the MIMcloud service for data management and transfer.
Catalog Number
-
Brand Name
ContourProtégéAI - CT Prostate
Version/Model Number
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
K193252
Product Code
QKB
Product Code Name
Radiological Image Processing Software For Radiation Therapy
Public Device Record Key
9865e8c6-3818-4176-8a70-8b4dd28ea937
Public Version Date
October 21, 2020
Public Version Number
1
DI Record Publish Date
October 13, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 24 |