IMPAX 58B5Y

GUDID 05414904216552

IMPAX SW CLIENT V6.7

Agfa HealthCare NV

Radiology 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 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 Radiological 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