FDA.reportPublic FDA data

SE Suite

Primary DI
05414904271124
Brand
SE Suite
Company
AGFA
Model
2.0
Catalog number
E5C34
Device description
Software
Published
2019-08-05
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
K071297000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071297000IMPAX SE SIGMACOM CLIENT (PACS WORKSTATION)Agfa Healthcare Corp.2007-06-22LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05414904271124PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05414904271124054149042711245414904271124

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(877)777-2432salesinfo@agfa.com

Regulatory Flags#

DUNS number
374444883
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
05414904027158CR MD4.0 GENERAL PLATECR MD4.0 GENERAL PLATE 10X12EJY1G2016-09-01
05414904027202CR MD4.0 GENERAL PLATECR MD4.0 GENERAL PLATE 35X43EJYU32016-09-01
05414904027219CR MD4.0 GENERAL PLATECR MD4.0 GENERAL PLATE 35X35EJYV52016-09-01
05414904027226CR MD4.0 GENERAL PLATECR MD4.0 GENERAL PLATE 24X30EJYW72016-09-01
05414904027363CR MD4.0 GENERAL PLATECR MD4.0 GENERAL PLATE 18X24EJYXA2016-09-01
05414904027509CR MD4.0 GENERAL PLATECR MD4.0 GENERAL PLATE 15X30EJYYC2016-09-01
05414904027516CR MD4.0 GENERAL PLATECR MD4.0 GENERAL PLATE 8X10EJYZE2016-09-01
05414904027943CR MD4.0T PLATECR MD4.0T PLATE 35X43E4UWL2016-09-01
05414904027967CR MD4.0T PLATECR MD4.0T PLATE 24X30E4UZR2016-09-01
05414904027998CR MD4.0T PLATECR MD4.0T PLATE 18X24E4VCK2016-09-01
05414904028001CR MD4.0T PLATECR MD4.0T PLATE 15X30E4VEO2016-09-01
05414904043257CR MD4.0R GENERAL PLATECR MD4.0R GENERAL PLATE 15X30E5PU32016-09-01
05414904043264CR MD4.0R GENERAL PLATECR MD4.0R GENERAL PLATE 18X24E5PT12016-09-01
05414904043271CR MD4.0R GENERAL PLATECR MD4.0R GENERAL PLATE 24X30E5PSY2016-09-01
05414904043288CR MD4.0R GENERAL PLATECR MD4.0R GENERAL PLATE 35X35E5PRW2016-09-01
05414904043295CR MD4.0R GENERAL PLATECR MD4.0R GENERAL PLATE 35X43E5PNO2016-09-01
05414904043301CR MD4.0R GENERAL SR PLATECR MD4.0R GENERAL SR PLATE 35X35E5POQ2016-09-01
05414904043318CR MD4.0R GENERAL SR PLATECR MD4.0R GENERAL SR PLATE 35X43E5PMM2016-09-01
05414904044100CR MD4.0 GENERAL PLATECR MD4.0 GENERAL PLATE 14X515O6MS2016-09-01
05414904092538CR MD1.0 GENERAL PLATECR MD1.0 GENERAL PLATE 35X435R3HW2016-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198953050996SnapShot FreezeGE Medical Systems, L.L.C.LLZ2026-10-19
05745000308385Cercare Medical NeurosuiteCercare Medical A/SLLZ2026-10-17
05745000308392Cercare Medical Neurosuite with Capillary FunctionCercare Medical A/SLLZ2026-10-17
05745000308408Cercare Medical Neurosuite (CMN) Capillary Function with Virtual ExpertCercare Medical A/SLLZ2026-10-17
05745000308361Cercare Oncology Virtual Expert; CMN Capillary Function with Oncology Virtual ExCercare Medical A/SLLZ2026-10-16
75401622502301Synthesis Vision ViewerSynthesis Health Intelligence IncLLZ2026-10-16
00889024713390ROSA® ShoulderOrthosoft IncLLZ2026-10-15
B037FFSMD0Synapse MobilityResolutionMD Inc.LLZ2026-10-15
B037NLIVD0Nicolab Image ViewerResolutionMD Inc.LLZ2026-10-15
B037RESMDD0ResolutionMDResolutionMD Inc.LLZ2026-10-15
00860013868918MICSI-PETMicroStructure Imaging, Inc.LLZ2026-10-14
00745426000059MiPACS V5Medicor ImagingLLZ2026-10-12
75401622522132Synthesis Vision ViewerSynthesis Health Intelligence IncLLZ2026-10-08
00198953200421EchoPACGE Vingmed Ultrasound A/SLLZ2026-10-07
00198953200438EchoPACGE Vingmed Ultrasound A/SLLZ2026-10-07
17540262200126Change Healthcare Stratus Imaging Diagnostic ViewerChange Healthcare Canada CompanyLLZ2026-10-05
00884838120433SmartCTPhilips Medical Systems Nederland B.V.LLZ2026-09-28
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
00889024673403NavitrackER®Orthosoft IncLLZ2026-06-26
00754016387128ANDIImeka Solutions IncLLZ2026-05-14
00198953059173ViewPointGE Healthcare GmbHLLZ2026-02-27
05745000308323Cercare Medical Neurosuite with Capillary FunctionCercare Medical A/SLLZ2026-01-30
05745000308330Cercare Medical Neurosuite (CMN) Capillary Function with Virtual ExpertCercare Medical A/SLLZ2026-01-30
00198953076873SenoIrisGE MEDICAL SYSTEMSLLZ2025-11-24
00195278951700EchoPACGE Vingmed Ultrasound A/SLLZ2025-08-08
00195278951717EchoPACGE Vingmed Ultrasound A/SLLZ2025-08-08