Duns Number:290318455
Device Description: A system based on the PROMAP – 3D Prostate Suite range intended to define prostate contour A system based on the PROMAP – 3D Prostate Suite range intended to define prostate contour and targets the region of interest on a prostate gland image in anticipation of a fusion with a system compatible with a 3D echography image realized as part of a targeted prostate gland biopsy.
Catalog Number
-
Brand Name
MR DRAW
Version/Model Number
KURO-4000
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
-
Product Code
LLZ
Product Code Name
System, Image Processing, Radiological
Public Device Record Key
30bfdfe2-e521-4457-8f66-a2ff1dc41fe9
Public Version Date
July 31, 2020
Public Version Number
1
DI Record Publish Date
July 23, 2020
Package DI Number
03665134000585
Quantity per Package
1
Contains DI Package
03665134000578
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
cardboard
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 13 |