Catalog Number

-

Brand Name

3Dimensions

Version/Model Number

INTELLIGENT 2D SOFTWARE

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

P080003

Product Code

OTE

Product Code Name

Digital breast tomosynthesis

Public Device Record Key

92db1e6b-921f-4d8e-ab50-5c5bd307e94b

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 14, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-