IMPAX 58B5Y

GUDID 05414904216552

IMPAX SW CLIENT V6.7

Agfa HealthCare NV

Radiology PACS software

• Primary Device ID: 05414904216552
• NIH Device Record Key: a76d8f8f-927e-4da1-a20e-793c429784d6
• Commercial Distribution Discontinuation: 2019-07-22
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: IMPAX
• Version Model Number: IMPAX 6.7
• Catalog Number: 58B5Y
• 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(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
• Phone: +1(877)777-2432
• Email: salesinfo@agfa.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05400874000727 [Primary]
GS1	05414904216552 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081976

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: 7
• Public Version Date: 2019-11-25
• Device Publish Date: 2016-09-16

Devices Manufactured by Agfa HealthCare NV

• 05400874001205 - IMPAX Clinical Applications: 2023-10-18 IMPAX Volume Viewing and IMPAX PET & SPECT Viewing
• 05414904216552 - IMPAX: 2019-11-25IMPAX SW CLIENT V6.7
• 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