FDA.reportPublic FDA data

ProPlan CMF

Primary DI
E314PROPLANCMF0
Brand
ProPlan CMF
Company
Materialise NV
Model
ProPlan CMF
Catalog number
ProPlan CMF
Device description
ProPlan CMF
Published
2017-02-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E314PROPLANCMF0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
CAD/CAM softwareA software program intended to provide computer-aided design (CAD) or computer-aided manufacturing (CAM) functionality for the production of patient-specific custom-made devices (e.g., orthopaedic implants, dental devices, anatomical models), treatment planning, simulation, and/or robotic capabilities for device production (e.g., 3-D printing).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
373139427
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05404028007006OrthoViewOrthoViewOrthoView2026-05-22
05404028001196Mimics Cardiac PlannerMimics Cardiac Planner TAVRMimics Cardiac Planner TAVR2026-05-15
05420060350856TruMatch CMF Titanium 3D Printed GuidesSD980.060SD980.0602026-04-29
05420060351631TruMatch CMF Titanium 3D Printed GuidesSD980.064SD980.0642026-04-29
05420060351648TruMatch CMF Titanium 3D Printed GuidesSD980.065SD980.0652026-04-29
05404028001202Mimics Automatic AlgorithmsMimics Automatic Algorithms CMF Orthognathic CT CBMimics Automatic Algorithms CMF Orthognathic CT CB2026-04-20
05404028001219Mimics Automatic Algorithms Mimics Automatic Algorithms CMF Reconstruction CT Mimics Automatic Algorithms CMF Reconstruction CT 2026-04-20
05404028001226Mimics Automatic Algorithms Mimics Automatic Algorithms Knee MRIMimics Automatic Algorithms Knee MRI2026-04-20
05404028001080Materialise Mimics Enlight CMFOrthognathic and Trauma PlannerOrthognathic and Trauma Planner2026-04-10
05404028001097Materialise Mimics Enlight CMFReconstruction PlannerReconstruction Planner2026-04-10
05404028001103Materialise Mimics Enlight CMFSplint DesignerSplint Designer2026-04-10
05404028001158Mimics FlowMimics FlowMimics Flow2026-03-23
05404028001172SurgiCase OnlineSurgiCase OnlineSurgiCase Online2026-03-23
05404028001189ProPlan CMF ProPlan CMF Online ProPlan CMF Online 2026-03-23
05404028000861Mimics Thoracic PlannerMimics Thoracic PlannerMimics Thoracic Planner2026-03-20
05420060360015BKS Total PSIKNM-OD01-00-01KNM-OD01-00-01 2022-09-21
05420060310027Zimmer Biomet Patient Specific InstrumentsKNM-ZB02-00-01KNM-ZB02-00-012018-08-11
05420060310034Zimmer Biomet Patient Specific InstrumentsKNM-ZB03-00-01KNM-ZB03-00-012018-08-11
05420060310041Zimmer Biomet Patient Specific InstrumentsKNM-ZB04-00-01KNM-ZB04-00-012018-08-11
05420060310065Zimmer Biomet Patient Specific InstrumentsKNM-ZB06-00-01KNM-ZB06-00-012018-08-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08437021722093ADAS 3DADAS3D MEDICAL S.L.LLZ2026-05-12
08800133400003ZeTTA PACSTae Young Soft Co., Ltd.LLZ2026-05-12
08033837938835no brandCEFLA SOCIETA' COOPERATIVALLZ2026-05-11
G725QFR300QFRQFR Solutions B.V.LLZ2026-05-11
G725QFR310QFRQFR Solutions B.V.LLZ2026-05-11
08800130800080Laon OrthoLaon Medi Inc.LLZ2026-05-07
G713ELU0010ElucisRealize Medical Inc.LLZ2026-05-07
08437021468045QP-Brain®QUIBIM SOCIEDAD LIMITADA.LLZ2026-05-06
08437023642016NemoCastSOFTWARE NEMOTEC SLLLZ2026-04-23
08437023642023NemoFABSOFTWARE NEMOTEC SLLLZ2026-04-23
M722C26103V260970ClearRead CT ServerRiverain Technologies, Inc.LLZ2026-04-20
M722CC26103V260970ClearRead CT ConsoleRiverain Technologies, Inc.LLZ2026-04-20
M722CD26103V260970ClearRead CT DockerRiverain Technologies, Inc.LLZ2026-04-20
M722CP26104V261040ClearRead CT Platform DockerRiverain Technologies, Inc.LLZ2026-04-20
17540262140262Change Healthcare Stratus Imaging ViewerChange Healthcare Canada CompanyLLZ2026-04-16
EOLENEUROINSIGHTV1P00Neuro InsightOlea Medical USALLZ2026-04-13
EOLENEUROVASIV1P00Neurovascular InsightOlea Medical USALLZ2026-04-13
08056304455864Caas QardiaPie Medical Imaging B.V.LLZ2026-04-03
08800290066784EVO Q10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.LLZ2026-04-03
08800340506147EVO QH10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.LLZ2026-04-03
08800340509988EVO XQ10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.LLZ2026-04-03
08800066200619JLK-AILINKJLK, Inc.LLZ2026-03-25
08800066200787JLK-CTPJLK, Inc.LLZ2026-03-25
08800066200794JLK-PWIJLK, Inc.LLZ2026-03-25
08800130400303Neurophet AQUA AD PlusNEUROPHET Inc.LLZ2026-02-24
08800290027471EV2-12SAMSUNG MEDISON CO., LTD.LLZ2026-01-28
08800290041767EA2-11AVSAMSUNG MEDISON CO., LTD.LLZ2026-01-28
08800290041811EA2-11ARSAMSUNG MEDISON CO., LTD.LLZ2026-01-28
08800290042481PA2-9SSAMSUNG MEDISON CO., LTD.LLZ2026-01-28
08800290042726CA2-13MSAMSUNG MEDISON CO., LTD.LLZ2026-01-28