Catalog Number

-

Brand Name

Q Series Diagnostic Ultrasound System

Version/Model Number

Q9

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

K153085,K153085,K153085,K153085,K153085,K153085,K153085,K153085,K153085,K153085,K153085,K153085,K153085,K153085,K153085,K153085,K153085,K153085,K153085,K153085,K153085,K153085,K153085,K153085,K153085,K153085,K153085,K153085,K153085

Product Code

IYN

Product Code Name

System, Imaging, Pulsed Doppler, Ultrasonic

Public Device Record Key

c64d5cc9-60ab-4e14-8d8e-0135bf776612

Public Version Date

September 05, 2022

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

06945121402330

Quantity per Package

1

Contains DI Package

06945121400060

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-