VIVIX-S 3643VAW - Flat Panel Detector, wireless36cm by 43 cm of size - VIEWORKS CO., LTD.

Duns Number:688274778

Device Description: Flat Panel Detector, wireless36cm by 43 cm of size

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

VIVIX-S 3643VAW

Version/Model Number

FXRD-3643VAW

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K200418

Product Code Details

Product Code

MQB

Product Code Name

Solid State X-Ray Imager (Flat Panel/Digital Imager)

Device Record Status

Public Device Record Key

7f78ca65-f22d-4c90-97f9-063d15936144

Public Version Date

October 14, 2020

Public Version Number

1

DI Record Publish Date

October 06, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"VIEWORKS CO., LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 23