FDA.reportPublic FDA data

OrthoView

Primary DI
05404028007006
Brand
OrthoView
Company
Materialise NV
Model
OrthoView
Catalog number
OrthoView
Device description
OrthoView
Published
2026-05-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
05404028007006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05404028007006054040280070065404028007006

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic/craniofacial implantation planning softwareA software program intended to add specific computer-assisted display, processing, and/or analysis capabilities to prepare for the implantation of an orthopaedic and/or craniomaxillofacial (CMF) prosthesis. Using digitized x-rays or imported computed tomography (CT) images, it provides implant-site anatomical images, and using computerized files representing implant patterns, provides the surgeon with images that help determine the appropriate size and placement of the implant.

Regulatory Flags#

DUNS number
373139427
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
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
05404028000830Mimics Automatic AlgorithmsMimics Automatic Algorithms CMF Orthognathic CT CBMimics Automatic Algorithms CMF Orthognathic CT CB2026-01-30
05404028001042Mimics Automatic Algorithms Mimics Automatic Algorithms CMF Reconstruction CT Mimics Automatic Algorithms CMF Reconstruction CT 2026-01-30
05404028001073Mimics Automatic Algorithms Mimics Automatic Algorithms Shoulder Arthroplasty Mimics Automatic Algorithms Shoulder Arthroplasty 2026-01-30
05404028001110SurgiCase Planner SurgiCase Shoulder Planner SurgiCase Shoulder Planner 2025-12-17
05404028001035Mimics Cardiac PlannerMimics Cardiac Planner TTVRMimics Cardiac Planner TTVR2025-12-15
05420060380792TRUMATCHSD900.057SD900.0572025-09-11
05420060380808TRUMATCHSD900.058SD900.0582025-09-11
05420060380815TRUMATCHSD900.059SD900.0592025-09-11
05420060380822TRUMATCHSD900.060SD900.0602025-09-11
05420060380839TRUMATCHSD980.033SD980.0332025-09-11
05420060380846TRUMATCHSD980.034SD980.0342025-09-11
05420060380853TRUMATCHSD980.035SD980.0352025-09-11
05420060380860TRUMATCHSD980.036SD980.0362025-09-11
05420060380877TRUMATCHSD980.037SD980.0372025-09-11
05420060380884TRUMATCHSD980.038SD980.0382025-09-11
05420060380891TRUMATCHSD980.039SD980.0392025-09-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850631008858Roentgen WorksBrit Systems, LLCLLZ2026-05-26
08800130400228Neurophet SCALE PETNEUROPHET Inc.LLZ2026-05-26
08800130400310Neurophet AQUANEUROPHET Inc.LLZ2026-05-26
00888118154231IPSKLS-Martin L.P.LLZ2026-05-25
08809985659300R2GATE WindowsMegagen Implant Co. LtdLLZ2026-03-24
10603295562108VELYS Hip NavigationDEPUY ORTHOPAEDICS, INC.LLZ2026-03-24
05404028000861Mimics Thoracic PlannerMaterialise NVLLZ2026-03-20
17540262140255Change Healthcare Stratus Imaging ViewerChange Healthcare Canada CompanyLLZ2026-03-19
08800018412008EConsole2DRTECH CorporationLLZ2026-03-17
75401622502288Synthesis Vision ViewerSynthesis Health Intelligence IncLLZ2026-03-17
00860010575314AS SoftwareAs Software, LLCLLZ2026-03-10
00860010575321AS SoftwareAs Software, LLCLLZ2026-03-10
04719878870009EBMEBM TECHNOLOGIES INCORPORATEDLLZ2026-03-10
04719878870108EBMEBM TECHNOLOGIES INCORPORATEDLLZ2026-03-10
04719878870122EBMEBM TECHNOLOGIES INCORPORATEDLLZ2026-03-10
04719878870191EBMEBM TECHNOLOGIES INCORPORATEDLLZ2026-03-10
04719878870276EBMEBM TECHNOLOGIES INCORPORATEDLLZ2026-03-10
04719878870290EBMEBM TECHNOLOGIES INCORPORATEDLLZ2026-03-10
09358140000079Quicktome Software SuiteOmniscient Neurotechnology Pty Ltd (o8t)LLZ2026-03-09
17540262090154Change Healthcare CardiologyChange Healthcare Canada CompanyLLZ2026-03-09
06971576834334uWSShanghai United Imaging Healthcare Co., Ltd.LLZ2026-03-08
06971576834341uWSShanghai United Imaging Healthcare Co., Ltd.LLZ2026-03-08
07350092810678Sectra Orthopedic PackageSectra ABLLZ2026-03-05
00198953059173ViewPointGE Healthcare GmbHLLZ2026-02-27
00850025268400Vitrea Advanced Visualization Canon Medical Informatics, Inc.LLZ2026-02-27
08800169200134ON3D3D ONS, INC.LLZ2026-02-19
B403IQS11004iQ-SYSTEM PACSIMAGE Information Systems Europe GmbHLLZ2026-02-19
00817886020677JointsMEDSTRAT, INC.LLZ2026-02-16
00860015443526CARPLCarpl.AI, Inc.LLZ2026-02-16
00862234000320vRad ViewervRadLLZ2026-02-13