THALES

GUDID 08054890480154

The detector is suitable for acquiring digital images in radiography modes. It allows radiological diagnostic examinations to be performed in real time. The acquired images are saved in the system memory, displayed on a high definition monitor (HD) and eventually transmitted to a diagnostic workstation. An intermediate storage of images is performed if a wireless connection is not available.

GENERAL MEDICAL MERATE SPA

Indirect flat panel x-ray detector

• Primary Device ID: 08054890480154
• NIH Device Record Key: 5dfcacf2-1655-4f6e-b4e9-a24630a6e819
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: THALES
• Version Model Number: Pixium 3543EZ
• Company DUNS: 428658934
• Company Name: GENERAL MEDICAL MERATE SPA
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08054890480154 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173395
• Premarket Notification: K213081

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: 3
• Public Version Date: 2019-05-07
• Device Publish Date: 2019-02-10

On-Brand Devices [THALES]

• 08054890480154: The detector is suitable for acquiring digital images in radiography modes. It allows radiologic
• 08054890480147: The detector is suitable for acquiring digital images in radiography modes. It allows radiologic