IMPAX Clinical Applications

GUDID 05400874001205

IMPAX Volume Viewing and IMPAX PET & SPECT Viewing

Agfa HealthCare NV

Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software

• Primary Device ID: 05400874001205
• NIH Device Record Key: 689c17b6-8e2c-44b3-9cdf-3a77c24eb36c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMPAX Clinical Applications
• Version Model Number: 4
• Company DUNS: 282853795
• Company Name: Agfa HealthCare NV
• 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: 1-866-599-3868
• Email: salesinfo@agfa.com
• Phone: 1-866-599-3868
• Email: salesinfo@agfa.com
• Phone: 1-866-599-3868
• Email: salesinfo@agfa.com
• Phone: 1-866-599-3868
• Email: salesinfo@agfa.com
• Phone: 1-866-599-3868
• Email: salesinfo@agfa.com
• Phone: 1-866-599-3868
• Email: salesinfo@agfa.com
• Phone: 1-866-599-3868
• Email: salesinfo@agfa.com
• Phone: 1-866-599-3868
• Email: salesinfo@agfa.com
• Phone: 1-866-599-3868
• Email: salesinfo@agfa.com
• Phone: 1-866-599-3868
• Email: salesinfo@agfa.com
• Phone: 1-866-599-3868
• Email: salesinfo@agfa.com
• Phone: 1-866-599-3868
• Email: salesinfo@agfa.com
• Phone: 1-866-599-3868
• Email: salesinfo@agfa.com
• Phone: 1-866-599-3868
• Email: salesinfo@agfa.com
• Phone: 1-866-599-3868
• Email: salesinfo@agfa.com
• Phone: 1-866-599-3868
• Email: salesinfo@agfa.com
• Phone: 1-866-599-3868
• Email: salesinfo@agfa.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05400874001205 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080013

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: 2019-07-22

Devices Manufactured by Agfa HealthCare NV

• 05400874001205 - IMPAX Clinical Applications: 2023-10-18IMPAX Volume Viewing and IMPAX PET & SPECT Viewing
• 05400874001205 - IMPAX Clinical Applications: 2023-10-18 IMPAX Volume Viewing and IMPAX PET & SPECT Viewing
• 05414904216552 - IMPAX: 2019-11-25 IMPAX SW CLIENT V6.7
• 05414904218525 - Enterprise Imaging Desktops: 2019-07-23 ENT IMG SW 8.
• 05414904218532 - Enterprise Imaging Xero Viewer: 2019-07-23 ENT IMG SW XERO VIEWER 8.1
• 05414904242902 - Enterprise Imaging Desktops: 2019-07-23
• 05414904242919 - Enterprise Imaging XERO Viewer: 2019-07-23
• 05414904252437 - Enterprise Imaging Desktops: 2019-07-23
• 05414904252444 - Enterprise Imaging XERO Viewer: 2019-07-23