FDA.reportPublic FDA data

510(k) K183105

Device
Mimics Medical
Applicant
Materialise NV
510(k) number
K183105
Product code
LLZ  
Decision
Substantially Equivalent (SESE)
Decision date
2019-03-27
Date received
2018-11-08
Regulation
892.2050
Classification name
System, Image Processing, Radiological
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Carina Martins
Address
Technologielaan 15 Leuven BE 3001 3001

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LLZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K262449AdvaViewADVAHEALTH SOLUTIONS, LLC2026-08-14
K261916NeuroQuant PETCortechs Labs, Inc.2026-08-12
K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)2026-07-31
K260588Cleerly LABSCleerly, Inc.2026-07-29
K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation2026-07-24
K262143ImageGrid StreamVueCandelis, Inc.2026-07-23
K260500ResolutionMDResolutionMD, Inc.2026-07-21
K262120Avara ViewerAvara Software2026-07-10
K2538993D-AnywhereProvect.AI2026-07-09
K261465INDIRA CLOUD VIEWERINDIGO TECHNOLOGIES2026-07-06
K260576MeVis AVM ContourMeVis Medical Solutions AG2026-06-30
K260231MiPACS V5 (1.0.0)Apryse Software Corp2026-06-25
K253421Perfusion Measurement Platform v1Quantified Imaging Limited2026-06-22
K2613522D Hip Planning SoftwareOne Ortho2026-06-08
K260116CustoMED ViewerCustoMED , Ltd.2026-06-03