Catalog Number

-

Brand Name

ACUSON S2000 Automated Breast Volume Scanner

Version/Model Number

10434730

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

K081148

Product Code

IYN

Product Code Name

System, imaging, pulsed doppler, ultrasonic

Public Device Record Key

512a6473-9d69-4125-b988-b9864555721a

Public Version Date

November 18, 2021

Public Version Number

9

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-