FDA.reportPublic FDA data

IMPAX Clinical Applications

Primary DI
05400874001205
Brand
IMPAX Clinical Applications
Company
Agfa HealthCare NV
Model
4
Device description
IMPAX Volume Viewing and IMPAX PET & SPECT Viewing
Published
2019-07-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K080013000
K111638000
K133135000
K161061000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080013000REGISTRATION AND FUSIONAgfa Healthcare Corporation2008-01-17LLZ
K111638000IMPAX VOLUME VIEWINGAgfa Healthcare N.V.2011-06-24LLZ
K133135000IMPAX VOLUME VIEWING 3.0Agfa Healthcare N.V.2014-03-07LLZ
K161061000IMPAX Volume Viewing 4.0Agfa Healthcare N.V.2016-06-22LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05400874001205PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05400874001205054008740012055400874001205

GMDN Terms#

Term, Definition table
TermDefinition
Radiological PACS-dedicated management softwareA software program dedicated for installation on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of a broad range of radiological images throughout the healthcare system. As a PACS-dedicated software, it is not primarily intended for diagnosis support, triage, or treatment planning. It does not incorporate adaptive/dynamic machine learning (ML) models.

Contacts#

Phone, Email table
PhoneEmail
1-866-599-3868salesinfo@agfa.com

Regulatory Flags#

DUNS number
282853795
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05400874000703Enterprise Imaging Desktops82019-07-22
05400874000710Enterprise Imaging XERO Viewer82019-07-22
05400874000727IMPAX62019-07-22
05414904216552IMPAXIMPAX 6.758B5Y2016-09-16
05414904218525Enterprise Imaging DesktopsEnterprise Imaging Desktops 8.15872F2016-09-16
05414904218532Enterprise Imaging Xero ViewerEnterprise Imaging Xero Viewer 8.15873H2016-09-16
05414904242902Enterprise Imaging Desktops8.1.1XDFNZ2018-03-14
05414904242919Enterprise Imaging XERO Viewer8.1.1XDFO22018-03-14
05414904252437Enterprise Imaging Desktops8.1.2XFNCQ2018-03-14
05414904252444Enterprise Imaging XERO Viewer8.1.2XFNK52018-03-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260456230215CHILI PACSCHILI GmbHLLZ2026-09-25
B141MEDISSUITEMRCT20260Medis Suite MRCTMedis Medical Imaging Systems B.V.LLZ2026-09-25
00850025268431Vitrea Advanced VisualizationCanon Medical Informatics, Inc.LLZ2026-09-21
08437021722109ADAS 3DADAS3D MEDICAL S.L.LLZ2026-09-18
07350092810722Sectra Orthopedic PackageSectra ABLLZ2026-09-06
00754016387128ANDIImeka Solutions IncLLZ2026-05-14
00198953059173ViewPointGE Healthcare GmbHLLZ2026-02-27
00817886020677JointsMEDSTRAT, INC.LLZ2026-02-16
00198953076873SenoIrisGE MEDICAL SYSTEMSLLZ2025-11-24
00817886020660JointsMEDSTRAT, INC.LLZ2025-08-09
00817886020653JointsMEDSTRAT, INC.LLZ2025-06-27
00860003424841OrthoGrid Hip TraumaOrthogrid Systems, Inc.LLZ2025-06-24
00817886020646JointsMEDSTRAT, INC.LLZ2025-04-30
00884838127746Radiology Operations Command Center ConsolePhilips Medical Systems Nederland B.V.LLZ2025-03-14
00817886020639JointsMEDSTRAT, INC.LLZ2025-03-07
00198715251623BrainSpec Core™ SoftwareBrainSpec Inc.LLZ2025-02-10
00817886020622JointsMEDSTRAT, INC.LLZ2025-02-03
00670082000610Modus PlanSynaptive Medical IncLLZ2025-01-17
00817886020615JointsMEDSTRAT, INC.LLZ2024-12-09
00817886020608JointsMEDSTRAT, INC.LLZ2024-11-01
00817886020592JointsMEDSTRAT, INC.LLZ2024-08-31
00195278753472ViewPointGE Healthcare GmbHLLZ2024-07-15
00817886020585JointsMEDSTRAT, INC.LLZ2024-06-08
00817886020578JointsMEDSTRAT, INC.LLZ2024-04-12
00817886020561JointsMEDSTRAT, INC.LLZ2024-02-10
00817886020554JointsMEDSTRAT, INC.LLZ2023-11-13
00350227000520EaglesoftPATTERSON TECHNOLOGY CENTERLLZ2023-10-25
00754016387111ANDIImeka Solutions IncLLZ2023-09-01
00817886020516JointsMEDSTRAT, INC.LLZ2023-05-29
00817886020509JointsMEDSTRAT, INC.LLZ2023-04-03