Catalog Number

-

Brand Name

myQA iON

Version/Model Number

MQ10-000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

K201798

Product Code

IYE

Product Code Name

Accelerator, Linear, Medical

Public Device Record Key

21b7712d-2817-4cb0-8fd4-45b8e3d9200f

Public Version Date

April 19, 2021

Public Version Number

1

DI Record Publish Date

April 09, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-