Prudent1417 - The Prudent is an Wireless/Wired flat panel x-ray - PIXXGEN Corporation

Duns Number:557796065

Device Description: The Prudent is an Wireless/Wired flat panel x-ray detector system that interfaces with, an The Prudent is an Wireless/Wired flat panel x-ray detector system that interfaces with, and acquires and digitized x-ray exposures from, standard radiographic system. The Prudent detector is designed to be used in any environment that would typically use a radiographic cassette for examination of human anatomy. The detector will display high quality images in approximately five seconds over a wide range of dose setting.The digital x-ray detector is configurable in several options depending materials such as TFT array(amorphous silicon or Indium Gallium Zinc Oxide), TFT substrate (glass or polyimide), TFT Pixel pitch and Scintillator (CsI or Gadox).

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More Product Details

Catalog Number

-

Brand Name

Prudent1417

Version/Model Number

Prudent1417

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

K211108

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

2f188cdc-5697-4af6-890f-6eb3b273f842

Public Version Date

January 05, 2022

Public Version Number

1

DI Record Publish Date

December 28, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PIXXGEN CORPORATION" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 15