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 Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector 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