PIXX1417

GUDID 08809378240115

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.

PIXXGEN Corporation

Indirect flat panel x-ray detector
Primary Device ID08809378240115
NIH Device Record Key10be392b-76f4-4ca4-baa8-97206c12835c
Commercial Distribution StatusIn Commercial Distribution
Brand NamePIXX1417
Version Model NumberPIXX1417 (Wired Detector)
Company DUNS557796065
Company NamePIXXGEN Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108809378240115 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-12-24
Device Publish Date2019-12-16

On-Brand Devices [PIXX1417]

08809378240160Device is a high resolution digital X-RAY imaging device commonly referred to as a flat panel de
08809378240115Device is a high resolution digital X-RAY imaging device commonly referred to as a flat panel de

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