FDA.reportPublic FDA data

Mimics Enlight

Primary DI
E314MIMICSENLIGHTMED0
Brand
Mimics Enlight
Company
Materialise NV
Model
Mimics Enlight Medical
Catalog number
Mimics Enlight Medical
Device description
Mimics Enlight Medical
Published
2019-08-28
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190874000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190874000Materialise Mimics EnlightMaterialise NV2019-06-05LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E314MIMICSENLIGHTMED0PrimaryHIBCC0

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
05404028001257SurgiCase PlannerSurgiCase Knee PlannerSurgiCase Knee Planner2026-05-28
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

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Primary DI, Brand, Company table
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00850059977576TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977583TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
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00850059977606TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977613TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977521TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977538TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977545TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977552TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977569TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
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00889024699762ROSA® ShoulderOrthosoft IncLLZ2026-06-26
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00889024699786ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00889024699793ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00889024699809ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00889024699816ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00889024699823ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00860012615308Denti.AI Auto-ChartDenti.AI Technology IncLLZ2026-06-24
00860012615315Denti.AI DetectDenti.AI Technology IncLLZ2026-06-24
00850631008872Roentgen WorksBrit Systems, LLCLLZ2026-06-23
00628184004500Intellijoint VIEWIntellijoint Surgical IncLLZ2026-06-09
00860005144082Brain AgeDeephealth, Inc.LLZ2026-06-08
07649997938038Swissmeda Dental Planning SystemSwissmeda AGLLZ2026-06-08
07649997938052Swissmeda Dental Planning SystemSwissmeda AGLLZ2026-06-08
00850025268417Vitrea Advanced VisualizationCanon Medical Informatics, Inc.LLZ2026-06-05
00850631008865Roentgen WorksBrit Systems, LLCLLZ2026-06-05