Catalog Number

SW-001

Brand Name

Sonata® System Software

Version/Model Number

SW-001

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 30, 2020

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

K173703

Product Code

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Public Device Record Key

bd557c4f-a8c2-4bf5-8ef1-2b60d3ca7df1

Public Version Date

May 19, 2021

Public Version Number

2

DI Record Publish Date

February 21, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-