PIXX1212

GUDID 08809378240122

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 panel type digital sensor receives X-Ray and converts to digital image. The digital signals are then read out by TFTs.

PIXXGEN Corporation

Indirect flat panel x-ray detector

• Primary Device ID: 08809378240122
• NIH Device Record Key: aa57a9ec-9ad0-44f3-ab29-6f7d4bac3c75
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PIXX1212
• Version Model Number: PIXX1212 (Wired Detector)
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809378240122 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182533

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: 2019-12-24
• Device Publish Date: 2019-12-16

On-Brand Devices [PIXX1212]

• 08809378240177: Device is a high resolution digital X-RAY imaging device commonly referred to as a flat panel de
• 08809378240122: Device is a high resolution digital X-RAY imaging device commonly referred to as a flat panel de