PIXX2430

Primary DI
08809378240184
Brand
PIXX2430
Company
PIXXGEN Corporation
Model
PIXX2430
Device description
PIXX2430 is a high-resolution digital X-Ray imaging device commonly referred to as a flat panel detect. 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.
Published
2021-12-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)Radiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190691000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190691000Pixx2430 Digital Diagnostic X-Ray Receptor PanelPixxgen Corporation2019-04-04MQB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809378240184PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809378240184088093782401848809378240184

GMDN Terms#

Term, Definition table
TermDefinition
Indirect flat panel x-ray detectorAn electrically-powered, cassette-like device intended to be used as part of an x-ray system to detect x-ray images following exposure, and create a digital signal; it is not dedicated to imaging of a specific anatomy. It includes two types of transducing technology (i.e., indirect): a scintillator [e.g. caesium iodide (CsI)] screen converts x-ray energy into light, followed by the conversion of light into a digital signal by photodiode array. The image data can be sent to an appropriate processing unit through a wired or wireless connection (e.g., Wi-Fi). It may be used in place of a fixed detector in x-ray imaging systems, e.g., as part of a digital imaging conversion system.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
557796065
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809378240023ATAL 9ATAL 9 (Wired Detector)2017-01-18
08809378240030ATAL 9ATAL 9 (Wireless Detector)2017-01-18
08809378240047ATAL 9 ATAL 9 (Portable Detector)2017-01-18
08809378240054ATAL 9ATAL 9 (ATCB-9)2017-01-18
08809378240061ATAL 9ATAL 9 (Battery Pack)2017-01-18
08809378240191Prudent1717Prudent17172021-12-28
08809378240207Prudent1417Prudent14172021-12-28
08809378240245Prudent1212Prudent12122021-12-28
08809378240108PIXX1717PIXX1717 (Wired Detector)2019-12-16
08809378240115PIXX1417PIXX1417 (Wired Detector)2019-12-16
08809378240122PIXX1212PIXX1212 (Wired Detector)2019-12-16
08809378240153PIXX1717PIXX1717 (Wireless Detector)2019-12-16
08809378240160PIXX1417PIXX1417 (Wireless Detector)2019-12-16
08809378240177PIXX1212PIXX1212 (Wireless Detector)2019-12-16

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