Digital Intraoral X-ray Imaging System - The Digital Intra-Oral X-Ray Imaging System - iRay Technology Co. Ltd.

Duns Number:421363780

Device Description: The Digital Intra-Oral X-Ray Imaging System (Pluto0001X/Pluto0002X) is used in conjunction The Digital Intra-Oral X-Ray Imaging System (Pluto0001X/Pluto0002X) is used in conjunction with dental Radiography in medical units. The product is used for dental X-ray examination and the diagnosis of structural diseases. The product is expected to be used in hospitals and clinics, operated and used by trained professionals under the guidance of doctors.This device is not intended for mammography and conventional photography applications.This device is suitable for providing dental radiography imaging for both adult and pediatric.

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More Product Details

Catalog Number

/

Brand Name

Digital Intraoral X-ray Imaging System

Version/Model Number

Pluto0002X

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)

Yes

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

MUH

Product Code Name

System, X-Ray, Extraoral Source, Digital

Device Record Status

Public Device Record Key

8a04761d-9e0f-45b4-837e-a4ba820164bb

Public Version Date

October 04, 2021

Public Version Number

3

DI Record Publish Date

July 09, 2021

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