ATAL 9

GUDID 08809378240054

ATAL 9 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. X-Ray photons are converted to digital output signals. The digital signals are then read out by TFTs. The image data file is saved at the computer for display, which can be linked with PACS and printed by DICOM printer through acquisition software. It is specifically designed to deliver X-Ray imaging for medical, veterinary and industrial applications.

PIXXGEN Corporation

Indirect flat panel x-ray detector
Primary Device ID08809378240054
NIH Device Record Key782b0597-dad9-4729-be70-22706740960f
Commercial Distribution StatusIn Commercial Distribution
Brand NameATAL 9
Version Model NumberATAL 9 (ATCB-9)
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
GS108809378240054 [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 StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-05-07
Device Publish Date2017-01-18

On-Brand Devices [ATAL 9]

08809378240061ATAL 9 is a high-resolution digital X-Ray imaging device commonly referred to as a flat panel de
08809378240054ATAL 9 is a high-resolution digital X-Ray imaging device commonly referred to as a flat panel de
08809378240047ATAL 9 is a high-resolution digital X-Ray imaging device commonly referred to as a flat panel de
08809378240030ATAL 9 is a high-resolution digital X-Ray imaging device commonly referred to as a flat panel de
08809378240023ATAL 9 is a high-resolution digital X-Ray imaging device commonly referred to as a flat panel de

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