DEVICE: Prudent1717 (08809378240191)
Device Identifier (DI) Information
Prudent1717
Prudent1717
In Commercial Distribution
PIXXGEN Corporation
Prudent1717
In Commercial Distribution
PIXXGEN Corporation
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 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).
The detector will display high quality images in approximately five seconds over a wide range of dose setting.
Device Characteristics
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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61108 | Indirect flat panel x-ray detector |
An 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.
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FDA Product Code
[?]Product Code | Product Code Name |
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MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K211108 | 000 |
Sterilization
Storage and Handling
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No storage/handling found |
Clinically Relevant Size
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No Device Sizes |
Device Record Status
c89f0c5f-7315-4b83-8594-4602652a826b
January 05, 2022
1
December 28, 2021
January 05, 2022
1
December 28, 2021
Alternative and Additional Identifiers Additional Identifiers
Package DI
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Secondary DI
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Unit of Use DI
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Unit of Use DI Number:
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CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined