DR 600 542WK

GUDID 05414904197202

DR 600 SEMI-AUTOMATIC

AGFA

Stationary basic diagnostic x-ray system, digital

• Primary Device ID: 05414904197202
• NIH Device Record Key: a152b365-cb02-4494-9cac-8289adf7136a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DR 600
• Version Model Number: 5530/200
• Catalog Number: 542WK
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05414904197202 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152639

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: 4
• Public Version Date: 2019-06-14
• Device Publish Date: 2016-09-01

On-Brand Devices [DR 600]

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