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161 devices · 126 companies · 2008 to 2026

Product code LLZ: System, Image Processing, Radiological

161 devices under product code LLZ, 2008 to 2026, from 126 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (151 of 161 here), the regulation, and MAUDE report counts by product code.

System, Image Processing, Radiological. 21 CFR 892.2050, Class II. MAUDE held 19,970 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.

Retrieved from FDA public records.

By year under product code LLZ

Companies with more than one device here

The newest 150 devices

161 devices under product code LLZ is more than one table should carry. The 150 newest decisions are below; every device has a page of its own, reached through the product-code and year lists above.

LLZ · newest 150 of 161 devices
DecisionDeviceCompanyPanelFDA
SubtleHD-PETK254013 · 510(k)Subtle Medical, Inc.Radiologydatabase entry
Acorn 3D SoftwareK251532 · 510(k)Mighty Oak MedicalRadiologydatabase entry
SurgiTwinK250290 · 510(k)TwinsightRadiologydatabase entry
Neuro Insight V1.0K243681 · 510(k)Olea Medical S.A.S.Radiologydatabase entry
GyriCalcK250686 · 510(k)NeuroSpectrum Insights Corp.Radiologydatabase entry
VersaViewerK243651 · 510(k)GE Medical Systems SCSRadiologydatabase entry
brAIn Shoulder PositioningK243292 · 510(k)Avatar MedicalRadiologydatabase entry
aiCockpit AI ViewerK241546 · 510(k)Fovia, Inc.Radiologydatabase entry
QuickRadK242838 · 510(k)Aikenist Technologies Pvt LtdRadiologydatabase entry
CaRi-PlaqueK242240 · 510(k)Caristo Diagnostics Ltd.Radiologydatabase entry
Brainomix 360 e-CTAK242123 · 510(k)Brainomix LimitedRadiologydatabase entry
Clarify DLK241350 · 510(k)GE Medical Systems Israel, Functional ImagingRadiologydatabase entry
Lightning ViewerK242362 · 510(k)Nexsys Electronics Inc. dba MedwebRadiologydatabase entry
PeekMed webK240926 · 510(k)Peek Health, S.A.Radiologydatabase entry
1CMR ProK242062 · 510(k)Mycardium AI LimitedRadiologydatabase entry
nordicMEDiVAK243209 · 510(k)NordicNeurolab ASRadiologydatabase entry
TRAQinform IQK233998 · 510(k)AIQ Global, Inc.Radiologydatabase entry
AiMIFYK240290 · 510(k)Subtle Medical, Inc.Radiologydatabase entry
MICSI-RMTK241121 · 510(k)Microstructure Imaging, Inc.Radiologydatabase entry
Syngo Carbon Enterprise AccessK240294 · 510(k)Siemens Healthcare GmbHRadiologydatabase entry
RapidK233582 · 510(k)iSchema View Inc.Radiologydatabase entry
CEPHX- Cephalometric Analysis SoftwareK231396 · 510(k)Orca Dental AI LTDRadiologydatabase entry
uOmnispace.MIK233176 · 510(k)Shanghai United Imaging Healthcare Co., Ltd.Radiologydatabase entry
StrokeViewer PerfusionK231570 · 510(k)NICo-Lab B.V.Radiologydatabase entry
DTX Studio ClinicK231898 · 510(k)Nobel Biocare ABRadiologydatabase entry
BonelogicK223757 · 510(k)Disior LtdRadiologydatabase entry
Myocardial Strain Software ApplicationK232661 · 510(k)Circle Cardiovascular ImagingRadiologydatabase entry
SwiftMRK230854 · 510(k)AIRS Medical Inc.Radiologydatabase entry
Veuron-Brain-pAb3K231642 · 510(k)Heuron Co., Ltd.Radiologydatabase entry
OFIX MIS AppK230252 · 510(k)Orthofix US LLCRadiologydatabase entry
JazzK223659 · 510(k)AI Medical AGRadiologydatabase entry
NEUROShieldK220034 · 510(k)In-Med Prognostics L3CRadiologydatabase entry
AIRAscoreK223180 · 510(k)AIRAmed GmbHRadiologydatabase entry
AutoplaqueK212758 · 510(k)Cedars-Sinai Medical Center: AIMRadiologydatabase entry
SubtleMRK223623 · 510(k)Subtle Medical Inc.Radiologydatabase entry
Neurophet AQUAK220437 · 510(k)NEUROPHET, Inc.Radiologydatabase entry
MR DWI/FLAIR Measurement V1.0K230552 · 510(k)Olea MedicalRadiologydatabase entry
Quantib ProstateK230772 · 510(k)Quantib BVRadiologydatabase entry
Ezra FlashK230264 · 510(k)Ezra AI, Inc.Radiologydatabase entry
Limbus ContourK230575 · 510(k)Limbus AI Inc.Radiologydatabase entry
FlightPlan for EmbolizationK223490 · 510(k)GE Medical Systems SCSRadiologydatabase entry
Xeleris V Processing and Review SystemK221680 · 510(k)GE HealthcareRadiologydatabase entry
TruPlan Computed TomographyK222593 · 510(k)Circle Cardiovascular Imaging, Inc.Radiologydatabase entry
MR Diffusion Perfusion Mismatch V1.0K223502 · 510(k)Olea MedicalRadiologydatabase entry
AIBOLIT 3D+K222458 · 510(k)Aibolit Technologies, LLCRadiologydatabase entry
TeraRecon NeuroK220349 · 510(k)TeraRecon, IncRadiologydatabase entry
AI4CMR v1.0K220624 · 510(k)AI4MedImaging Medical Solutions S.A.Radiologydatabase entry
ElucidVivo A.3K221463 · 510(k)Elucid Bioimaging Inc.Radiologydatabase entry
SwiftMRK220416 · 510(k)AIRS Medical Inc.Radiologydatabase entry
Quantib ProstateK221106 · 510(k)Quantib BVRadiologydatabase entry
Segment 3DPrintK211966 · 510(k)Medviso ABRadiologydatabase entry
aPROMISE XK220590 · 510(k)EXINI Diagnostics ABRadiologydatabase entry
ClariPulmoK203783 · 510(k)ClariPi Inc.Radiologydatabase entry
RapidK213165 · 510(k)iSchema View Inc.Radiologydatabase entry
Quantib NDK213737 · 510(k)Quantib B.V.Radiologydatabase entry
UNiD Spine AnalyzerK212005 · 510(k)MEDICREA International, Inc.Radiologydatabase entry
AIBOLIT 3D+K211443 · 510(k)AIbolit Technologies, LLCRadiologydatabase entry
FlightPlan for LiverK210807 · 510(k)GE Medical Systems SCSRadiologydatabase entry
SwiftMRK210999 · 510(k)AIRS Medical Inc.Radiologydatabase entry
RBkneeK203696 · 510(k)Radiobotics ApSRadiologydatabase entry
TruSPECT Radiological Image Processing StationK212230 · 510(k)Spectrum Dynamics Medical LtdRadiologydatabase entry
aPROMISEK211655 · 510(k)EXINI Diagnostics ABRadiologydatabase entry
ClariCT.AIK212074 · 510(k)ClariPi Inc.Radiologydatabase entry
Volpara Imaging SoftwareK211279 · 510(k)Volpara Health Technologies LimitedRadiologydatabase entry
Qmenta Care Platform FamilyK202718 · 510(k)Mint Labs, Inc., d/b/a. QMENTARadiologydatabase entry
Overjet Dental AssistK210187 · 510(k)Overjet, Inc.Radiologydatabase entry
SIS SystemK210071 · 510(k)Surgical Information Sciences, Inc.Radiologydatabase entry
SubtleMRK203182 · 510(k)Subtle Medical, Inc.Radiologydatabase entry
NinesMeasureK202990 · 510(k)Nines, Inc.Radiologydatabase entry
TruPlanK202212 · 510(k)Circle Cardiovascular Imaging Inc.Radiologydatabase entry
Synapse 3D, Synapse 3D Base Tools v6.1K203103 · 510(k)Fujifilm CorporationRadiologydatabase entry
QUIBIM Precision ProstateK203582 · 510(k)QUIBIM S.L.Radiologydatabase entry
BrainInsightK202414 · 510(k)Hyperfine Research, IncRadiologydatabase entry
AI MetricsK202229 · 510(k)AI Metrics, LLCRadiologydatabase entry
HealthJOINTK202487 · 510(k)Zebra Medical Vision Ltd.Radiologydatabase entry
CorInsights MRIK193287 · 510(k)ADM Diagnostics, Inc.Radiologydatabase entry
PROViewK193306 · 510(k)GE Medical Systems SCSRadiologydatabase entry
Neuro.Al AlgorithmK200750 · 510(k)TeraRecon, Inc.Radiologydatabase entry
A View LCSK201710 · 510(k)Coreline Soft Co., Ltd.Radiologydatabase entry
Quantib ProstateK202501 · 510(k)Quantib BVRadiologydatabase entry
Cleerly Labs v2.0K202280 · 510(k)Cleerly, Inc.Radiologydatabase entry
THINQK192051 · 510(k)CorticoMetrics LLCRadiologydatabase entry
Xeleris V Processing and Review SystemsK201103 · 510(k)GE HealthcareRadiologydatabase entry
EchoPAC Software Only, EchoPAC Plug-InK200852 · 510(k)GE Medical Systems Ultrasound and Primary Care DiagnosticsRadiologydatabase entry
AVAK201369 · 510(k)See-Mode Technologies Pte. Ltd.Radiologydatabase entry
AVIEWK200714 · 510(k)Coreline Soft Co., LtdRadiologydatabase entry
TOMTEC-ARENAK201632 · 510(k)TOMTEC Imaging Systems GmbHRadiologydatabase entry
Limbus ContourK201232 · 510(k)Limbus AI Inc.Radiologydatabase entry
AI-Rad Companion EngineK193294 · 510(k)Siemens Medical Solutions USA, Inc.Radiologydatabase entry
AI-Rad Companion Brain MRK193290 · 510(k)Siemens Medical Solutions USA, Inc.Radiologydatabase entry
AVIEW LCSK193220 · 510(k)Coreline Soft Co., LtdRadiologydatabase entry
icobrain-ctpK192962 · 510(k)Icometrix NVRadiologydatabase entry
densitas densityaiK192973 · 510(k)Densitas, Inc.Radiologydatabase entry
ADAS 3DK191125 · 510(k)Galgo Medical S.LRadiologydatabase entry
QyScore SoftwareK192531 · 510(k)QynapseRadiologydatabase entry
IcobrainK192130 · 510(k)Icometrix NVRadiologydatabase entry
NemoScanK192571 · 510(k)Software Nemotec S.L.Radiologydatabase entry
PhantomMSK TraumaK192279 · 510(k)OrthoGrid Systems Inc.Radiologydatabase entry
RSI-MRI+K191278 · 510(k)MultiModal Imaging Services Corporation (dba HealthLytix)Radiologydatabase entry
MEDIP PROK191026 · 510(k)MEDICALIP Co., LtdRadiologydatabase entry
Cleerly LabsK190868 · 510(k)Cleerly IncRadiologydatabase entry
KOALAK192109 · 510(k)IB Lab GmbHRadiologydatabase entry
Merge PACSK192455 · 510(k)Merge Healthcare IncorporatedRadiologydatabase entry
Ventripoint Medical System PlusK191493 · 510(k)Ventripoint Diagnostics, Ltd.Radiologydatabase entry
SubtleMRK191688 · 510(k)Subtle Medical, Inc.Radiologydatabase entry
SIS Software Version 3.6.0K192304 · 510(k)Surgical Information Sciences, Inc.Radiologydatabase entry
D2PK183489 · 510(k)3D Systems, Inc.Radiologydatabase entry
aBSIK191262 · 510(k)EXINI Diagnostics ABRadiologydatabase entry
iNtuition-Structural Heart ModuleK191585 · 510(k)TeraRecon Inc.Radiologydatabase entry
ClariCT.AIK183460 · 510(k)ClariPI Inc.Radiologydatabase entry
SurgicalARK190764 · 510(k)MEDIVIS, Inc.Radiologydatabase entry
Lung Vision SystemK183593 · 510(k)Body Vision Medical Ltd.Radiologydatabase entry
SIS Software version 3.3.0K183019 · 510(k)Surgical Information Sciences, Inc.Radiologydatabase entry
AI Rad CompanionK183272 · 510(k)Siemens Medical Solutions USA, Inc.Radiologydatabase entry
MRCP+ v1.0K183133 · 510(k)Perspectum Diagnostics LtdRadiologydatabase entry
AmCAD-UOK180867 · 510(k)AmCad BioMed CorporationRadiologydatabase entry
Quantib NDK182564 · 510(k)Quantib BVRadiologydatabase entry
iSchemaView RAPIDK182130 · 510(k)iSchemaView, Inc.Radiologydatabase entry
vascuCAPK183012 · 510(k)Elucid Bioimaging Inc.Radiologydatabase entry
Centricity Universal ViewerK182419 · 510(k)GE HealthcareRadiologydatabase entry
Vitrea CT Brain PerfusionK181247 · 510(k)Vital Images, Inc.Radiologydatabase entry
icobrainK181939 · 510(k)icometrix NVRadiologydatabase entry
Arterys MICAK182034 · 510(k)Arterys Inc.Radiologydatabase entry
Ziostation2K181892 · 510(k)Ziosoft, Inc.Radiologydatabase entry
Volpara Imaging SoftwareK182310 · 510(k)Volpara Health Technologies LimitedRadiologydatabase entry
Quantitative Total Extensible ImagingK173444 · 510(k)AIQ Solutions, Inc.Radiologydatabase entry
DenSeeMammoK173574 · 510(k)StatlifeRadiologydatabase entry
EchoMD Automated Ejection Fraction SoftwareK173780 · 510(k)Bay Labs, Inc.Radiologydatabase entry
Viz CTPK180161 · 510(k)Viz.ai, Inc.Radiologydatabase entry
Quantib BrainK173939 · 510(k)Quantib BVRadiologydatabase entry
iQMRK173605 · 510(k)Medic Vision - Imaging Solutions LtdRadiologydatabase entry
DM-DensityK170540 · 510(k)Densitas, Inc.Radiologydatabase entry
UNiD Spine AnalyzerK180091 · 510(k)Medicrea InternationalRadiologydatabase entry
Arterys Oncology DLK173542 · 510(k)Arterys Inc.Radiologydatabase entry
Illumeo SystemK173588 · 510(k)Philips Medical Systems Technologies, Ltd.Radiologydatabase entry
cNeuro cMRIK171328 · 510(k)Combinostics OyRadiologydatabase entry
Radiomics App v1.0K173420 · 510(k)Microsoft Corp.Radiologydatabase entry
Infinitt PACS 7.0K172803 · 510(k)Infinitt Healthcare Co.,Ltd.Radiologydatabase entry
QuantraK163623 · 510(k)HOLOGIC, INC.Radiologydatabase entry
NeuroQuantK170981 · 510(k)CorTechs Labs, IncRadiologydatabase entry
syngo Application SoftwareK170747 · 510(k)Siemens Medical Solutions, USA, Inc.Radiologydatabase entry
SmartTargetK170250 · 510(k)SmartTarget, Ltd.Radiologydatabase entry
UNiD Spine AnalyzerK170172 · 510(k)MEDICREA INTERNATIONALRadiologydatabase entry
Lung VisionK163622 · 510(k)BODY VISION MEDICAL LTD.Radiologydatabase entry
AmCAD-UVK170069 · 510(k)AmCad BioMed CorporationRadiologydatabase entry
SIS SoftwareK162830 · 510(k)Surgical Information Sciences, Inc.Radiologydatabase entry
Quantib Brain 1.2K163013 · 510(k)Quantib BVRadiologydatabase entry
Arterys Cardio DLK163253 · 510(k)ARTERYS INC.Radiologydatabase entry
ClearView cCADK161959 · 510(k)ClearView Diagnostics Inc.Radiologydatabase entry
CT CoPilotK161322 · 510(k)ZEPMED, LLC.Radiologydatabase entry

Every product code in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.

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