Duns Number:108968505
Device Description: The QuantX Breast MRI Biopsy Guidance Plugin is a software application that assists users The QuantX Breast MRI Biopsy Guidance Plugin is a software application that assists users of the QuantX software device in planning MRI guided interventional procedures.
Catalog Number
2
Brand Name
QuantX
Version/Model Number
Breast MRI Biopsy Guidance Plugin
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K191959
Product Code
LLZ
Product Code Name
System, Image Processing, Radiological
Public Device Record Key
1d8dfe1b-e660-4e85-9707-b3de7015e088
Public Version Date
March 06, 2020
Public Version Number
1
DI Record Publish Date
February 27, 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 |