MiniX-S - The MiniX-S is an x-ray generating device which - DigiMed Co., Ltd.

Duns Number:688265810

Device Description: The MiniX-S is an x-ray generating device which is mainly designed for dental examination. The MiniX-S is an x-ray generating device which is mainly designed for dental examination.The device has an x-ray tube for generating x-rays, a high voltage transformer for generating high voltages, a high voltage rectification circuit for transforming and boosting AC voltage to mixed pulse voltage, a high voltage divide circuit for lowering high voltage to low voltage to measure and calibrate high voltages, as well as a high voltage tube tank, a high frequency inverter circuit for generating high voltages, a control P.C.B for controlling, saving and displaying the data, a power P.C.B for supplying power to the circuit and apparatus in housing, user interface (LCD screen) and beam limiting part (x-ray emitting cone).The apparatuses above can be embedded in one or several cases, and except for the radiation opening in the x-ray system, all units are completely shielded by lead or high-density materials, protecting patients and users from unnecessary exposure of radiation.The device is intended to be used by trained dentists and dental technicians as an extra-oral X-ray source producing diagnostic X-ray images using with intra-oral image receptors. Its use is intended for adults and pediatric subjects both.

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More Product Details

Catalog Number

1

Brand Name

MiniX-S

Version/Model Number

1

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

EHD

Product Code Name

Unit, X-Ray, Extraoral With Timer

Device Record Status

Public Device Record Key

dba0ff16-f300-4520-a67a-ff2e050b8e0b

Public Version Date

April 01, 2019

Public Version Number

4

DI Record Publish Date

January 19, 2018

Additional Identifiers

Package DI Number

88800021800027

Quantity per Package

8

Contains DI Package

08800021800021

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton Package