ATAL 9

GUDID 08809378240023

ATAL 9 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. X-Ray photons are converted to digital output signals. The digital signals are then read out by TFTs. The image data file is saved at the computer for display, which can be linked with PACS and printed by DICOM printer through acquisition software. It is specifically designed to deliver X-Ray imaging for medical, veterinary and industrial applications.

PIXXGEN Corporation

Indirect flat panel x-ray detector

• Primary Device ID: 08809378240023
• NIH Device Record Key: 5f5fa70f-8337-4904-b61b-0cf5c1fabe5d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ATAL 9
• Version Model Number: ATAL 9 (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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809378240023 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152151

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: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-05-07
• Device Publish Date: 2017-01-18

On-Brand Devices [ATAL 9]

• 08809378240061: ATAL 9 is a high-resolution digital X-Ray imaging device commonly referred to as a flat panel de
• 08809378240054: ATAL 9 is a high-resolution digital X-Ray imaging device commonly referred to as a flat panel de
• 08809378240047: ATAL 9 is a high-resolution digital X-Ray imaging device commonly referred to as a flat panel de
• 08809378240030: ATAL 9 is a high-resolution digital X-Ray imaging device commonly referred to as a flat panel de
• 08809378240023: ATAL 9 is a high-resolution digital X-Ray imaging device commonly referred to as a flat panel de