Catalog Number

K9301636A

Brand Name

Coronis Fusion 6 MP

Version/Model Number

MDCC-6530

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

K191845

Product Code

PGY

Product Code Name

Display, diagnostic radiology

Public Device Record Key

12a07083-4fb4-44d3-b3fe-9f6cdb86fbba

Public Version Date

July 24, 2020

Public Version Number

2

DI Record Publish Date

October 15, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-