Wireless digital flat panel detector - Mars1417V-PSI wireless digital flat panel - iRay Technology Co. Ltd.

Duns Number:421363780

Device Description: Mars1417V-PSI wireless digital flat panel detector with only one package and with E-COM so Mars1417V-PSI wireless digital flat panel detector with only one package and with E-COM software.

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More Product Details

Catalog Number

-

Brand Name

Wireless digital flat panel detector

Version/Model Number

Mars1417V-PSI

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

-

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

d2ebcfe8-ae68-450b-904b-a760e96ad1a4

Public Version Date

May 07, 2019

Public Version Number

3

DI Record Publish Date

October 31, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"IRAY TECHNOLOGY 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. 32