Prudent1212

Primary DI
08809378240245
Brand
Prudent1212
Company
PIXXGEN Corporation
Model
Prudent1212
Device description
The Prudent is an Wireless/Wired flat panel x-ray detector system that interfaces with, and acquires and digitized x-ray exposures from, standard radiographic system. The Prudent detector is designed to be used in any environment that would typically use a radiographic cassette for examination of human anatomy. The detector will display high quality images in approximately five seconds over a wide range of dose setting.The digital x-ray detector is configurable in several options depending materials such as TFT array(amorphous silicon or Indium Gallium Zinc Oxide), TFT substrate (glass or polyimide), TFT Pixel pitch and Scintillator (CsI or Gadox).
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
K211108000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211108000Prudent 1717, Prudent 1417, Prudent 1212Pixxgen Corporation2021-06-04MQB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809378240245PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809378240245088093782402458809378240245

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
08809378240184PIXX2430PIXX24302021-12-28
08809378240191Prudent1717Prudent17172021-12-28
08809378240207Prudent1417Prudent14172021-12-28
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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