Duns Number:108968505
Device Description: QuantX is a software program that analyzes patient breast images, and is designed to aid r QuantX is a software program that analyzes patient breast images, and is designed to aid radiologists in the characterization of lesions as part of high-risk screening or diagnostic work-up.
Catalog Number
1
Brand Name
QuantX
Version/Model Number
Breast MRI
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
DEN170022
Product Code
POK
Product Code Name
Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
Public Device Record Key
cb5dab50-6799-44b6-98e8-e03607be625e
Public Version Date
February 27, 2020
Public Version Number
1
DI Record Publish Date
February 19, 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 |