Prudent1212

GUDID 08809378240245

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).

PIXXGEN Corporation

Indirect flat panel x-ray detector

Primary Device ID	08809378240245
NIH Device Record Key	90915332-d4be-4391-bbe7-ddfcb19da96e
Commercial Distribution Status	In Commercial Distribution
Brand Name	Prudent1212
Version Model Number	Prudent1212
Company DUNS	557796065
Company Name	PIXXGEN Corporation
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809378240245 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K211108

FDA Product Code

MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2022-01-05
Device Publish Date	2021-12-28

Devices Manufactured by PIXXGEN Corporation

08809378240184 - PIXX2430	2022-01-05 PIXX2430 is a high-resolution digital X-Ray imaging device commonly referred to as a flat panel detect. X-Ray photons are conver
08809378240191 - Prudent1717	2022-01-05 The Prudent is an Wireless/Wired flat panel x-ray detector system that interfaces with, and acquires and digitized x-ray exposur
08809378240207 - Prudent1417	2022-01-05 The Prudent is an Wireless/Wired flat panel x-ray detector system that interfaces with, and acquires and digitized x-ray exposur
08809378240245 - Prudent1212	2022-01-05The 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).
08809378240245 - Prudent1212	2022-01-05 The Prudent is an Wireless/Wired flat panel x-ray detector system that interfaces with, and acquires and digitized x-ray exposur
08809378240108 - PIXX1717	2019-12-24 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 p
08809378240115 - PIXX1417	2019-12-24 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 p
08809378240122 - PIXX1212	2019-12-24 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 p
08809378240153 - PIXX1717	2019-12-24 PIXX1717 is a high-resolution digital X-Ray imaging device commonly referred to as a flat panel detect. X-Ray photons are conver