PIXX1212

GUDID 08809378240122

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 ID08809378240122
NIH Device Record Keyaa57a9ec-9ad0-44f3-ab29-6f7d4bac3c75
Commercial Distribution StatusIn Commercial Distribution
Brand NamePIXX1212
Version Model NumberPIXX1212 (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 Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108809378240122 [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 [PIXX1212]

08809378240177Device is a high resolution digital X-RAY imaging device commonly referred to as a flat panel de
08809378240122Device is a high resolution digital X-RAY imaging device commonly referred to as a flat panel de

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