IMPAX Clinical Applications

GUDID 05400874001205

IMPAX Volume Viewing and IMPAX PET & SPECT Viewing

Agfa HealthCare NV

Radiological PACS software
Primary Device ID05400874001205
NIH Device Record Key689c17b6-8e2c-44b3-9cdf-3a77c24eb36c
Commercial Distribution StatusIn Commercial Distribution
Brand NameIMPAX Clinical Applications
Version Model Number4
Company DUNS282853795
Company NameAgfa HealthCare NV
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-866-599-3868
Emailsalesinfo@agfa.com
Phone1-866-599-3868
Emailsalesinfo@agfa.com
Phone1-866-599-3868
Emailsalesinfo@agfa.com
Phone1-866-599-3868
Emailsalesinfo@agfa.com
Phone1-866-599-3868
Emailsalesinfo@agfa.com
Phone1-866-599-3868
Emailsalesinfo@agfa.com
Phone1-866-599-3868
Emailsalesinfo@agfa.com
Phone1-866-599-3868
Emailsalesinfo@agfa.com
Phone1-866-599-3868
Emailsalesinfo@agfa.com
Phone1-866-599-3868
Emailsalesinfo@agfa.com
Phone1-866-599-3868
Emailsalesinfo@agfa.com
Phone1-866-599-3868
Emailsalesinfo@agfa.com
Phone1-866-599-3868
Emailsalesinfo@agfa.com
Phone1-866-599-3868
Emailsalesinfo@agfa.com
Phone1-866-599-3868
Emailsalesinfo@agfa.com
Phone1-866-599-3868
Emailsalesinfo@agfa.com
Phone1-866-599-3868
Emailsalesinfo@agfa.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105400874001205 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-10-18
Device Publish Date2019-07-22

Devices Manufactured by Agfa HealthCare NV

05400874001205 - IMPAX Clinical Applications2023-10-18IMPAX Volume Viewing and IMPAX PET & SPECT Viewing
05400874001205 - IMPAX Clinical Applications2023-10-18 IMPAX Volume Viewing and IMPAX PET & SPECT Viewing
05414904216552 - IMPAX2019-11-25 IMPAX SW CLIENT V6.7
05414904218525 - Enterprise Imaging Desktops2019-07-23 ENT IMG SW 8.
05414904218532 - Enterprise Imaging Xero Viewer2019-07-23 ENT IMG SW XERO VIEWER 8.1
05414904242902 - Enterprise Imaging Desktops2019-07-23
05414904242919 - Enterprise Imaging XERO Viewer2019-07-23
05414904252437 - Enterprise Imaging Desktops2019-07-23
05414904252444 - Enterprise Imaging XERO Viewer2019-07-23

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