DR 600

GUDID 05414904274330

DR with option for Tomosynthesis

AGFA

Stationary basic diagnostic x-ray system, digital

• Primary Device ID: 05414904274330
• NIH Device Record Key: bfccd8a1-1c2d-47ef-a722-429381c2d66a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DR 600
• Version Model Number: 5530/100
• Company DUNS: 374444883
• Company Name: AGFA
• 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

Customer Support Contacts

• Phone: +1(877)777-2432
• Email: salesinfo@agfa.com
• Phone: +1(877)777-2432
• Email: salesinfo@agfa.com
• Phone: +1(877)777-2432
• Email: salesinfo@agfa.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05414904196298 [Previous]
GS1	05414904274330 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193262

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: 2020-05-25
• Device Publish Date: 2020-05-15

On-Brand Devices [DR 600]

• 05414904197202: DR 600 SEMI-AUTOMATIC
• 05414904196298: DR 600 FULLY AUTOMATIC
• 05414904274330: DR with option for Tomosynthesis