PIXX1212 - Device is a high resolution digital X-RAY imaging - PIXXGEN Corporation

Duns Number:557796065

Device Description: Device is a high resolution digital X-RAY imaging device commonly referred to as a flat pa Device is a high resolution digital X-RAY imaging device commonly referred to as a flat panel detect. A built-in a-Si TFT flat panel type digital sensor receives X-Ray and converts to digital image. The digital signals are then read out by TFTs.

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More Product Details

Catalog Number

-

Brand Name

PIXX1212

Version/Model Number

PIXX1212 (Wireless Detector)

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

K182533

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

603afdb8-4a8d-454b-a475-15f7b78f0adf

Public Version Date

December 24, 2019

Public Version Number

1

DI Record Publish Date

December 16, 2019

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