Catalog Number

3

Brand Name

QuantX

Version/Model Number

Breast MRI SE

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 19, 2020

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

K170195

Product Code

LLZ

Product Code Name

System, Image Processing, Radiological

Public Device Record Key

94992ba6-5309-44bd-98b2-595d1367e0fc

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

-