SE Suite E5C34

GUDID 05414904271124

Software

AGFA

Radiological PACS software

• Primary Device ID: 05414904271124
• NIH Device Record Key: 3ac4aed1-f52d-42cb-8e46-ffebe6c7dab2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SE Suite
• Version Model Number: 2.0
• Catalog Number: E5C34
• 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: false
• Manufacturing Date: false
• 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
• 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
• 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
• 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
• 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
• 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	05414904271124 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071297

FDA Product Code

• LLZ: System, image processing, radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-10-18
• Device Publish Date: 2019-08-05

Devices Manufactured by AGFA

• 05414904271124 - SE Suite: 2023-10-18Software
• 05414904271124 - SE Suite: 2023-10-18 Software
• 05414904208168 - NX 3.0: 2023-07-26
• 05414904233320 - NX 4.0: 2023-07-26
• 05414904281321 - DR 400: 2023-03-31
• 05414904225066 - Mamoray HDR-C Plus: 2022-11-24
• 05414904231678 - Dentus M2 Comfort: 2022-11-24
• 05414904231692 - Dentus M2 Comfort: 2022-11-24
• 05414904231531 - Dentus Ortholux Register: 2022-11-14