AI devices with FDA product code LLZ — System, Image Processing, Radiological
Product code LLZ (“System, Image Processing, Radiological” in openFDA) covers 161 devices on the FDA AI-enabled list, from 126 companies. Most are reviewed by the Radiology panel (161). The most recent decision was SubtleHD-PET (1.x) on May 14, 2026.
161AI devices
110Companies
2008First decision
2026-05-14Latest decision
Trend: devices per year
'08'12'16'18'20'22'24'26
Top companies
All 161 devices, newest first
- SubtleHD-PET (1.x)Subtle Medical, Inc. · Radiology
- Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical · Radiology
- SurgiTwinTwinsight · Radiology
- Neuro Insight V1.0Olea Medical S.A.S. · Radiology
- GyriCalc (Version 1.0.0)NeuroSpectrum Insights Corp. · Radiology
- VersaViewerGE Medical Systems SCS · Radiology
- brAIn Shoulder PositioningAvatar Medical · Radiology
- aiCockpit AI ViewerFovia, Inc. · Radiology
- QuickRadAikenist Technologies Pvt Ltd · Radiology
- CaRi-PlaqueCaristo Diagnostics Ltd. · Radiology
- Brainomix 360 e-CTABrainomix Limited · Radiology
- Clarify DLGE Medical Systems Israel, Functional Imaging · Radiology
- Lightning ViewerNexsys Electronics Inc. dba Medweb · Radiology
- PeekMed webPeek Health, S.A. · Radiology
- 1CMR ProMycardium AI Limited · Radiology
- nordicMEDiVANordicNeurolab AS · Radiology
- TRAQinform IQAIQ Global, Inc. · Radiology
- AiMIFY (1.x)Subtle Medical, Inc. · Radiology
- MICSI-RMTMicrostructure Imaging, Inc. · Radiology
- Syngo Carbon Enterprise Access (VA40A)Siemens Healthcare GmbH · Radiology
- RapidiSchema View Inc. · Radiology
- CEPHX- Cephalometric Analysis SoftwareOrca Dental AI LTD · Radiology
- uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd. · Radiology
- StrokeViewer PerfusionNICo-Lab B.V. · Radiology
- DTX Studio Clinic (4.0)Nobel Biocare AB · Radiology
- BonelogicDisior Ltd · Radiology
- Myocardial Strain Software ApplicationCircle Cardiovascular Imaging · Radiology
- SwiftMRAIRS Medical Inc. · Radiology
- Veuron-Brain-pAb3Heuron Co., Ltd. · Radiology
- OFIX MIS AppOrthofix US LLC · Radiology
- JazzAI Medical AG · Radiology
- NEUROShieldIn-Med Prognostics L3C · Radiology
- AIRAscoreAIRAmed GmbH · Radiology
- AutoplaqueCedars-Sinai Medical Center: AIM · Radiology
- SubtleMR (2.3.x)Subtle Medical Inc. · Radiology
- Neurophet AQUANEUROPHET, Inc. · Radiology
- MR DWI/FLAIR Measurement V1.0Olea Medical · Radiology
- Quantib ProstateQuantib BV · Radiology
- Ezra FlashEzra AI, Inc. · Radiology
- Limbus ContourLimbus AI Inc. · Radiology
- FlightPlan for EmbolizationGE Medical Systems SCS · Radiology
- Xeleris V Processing and Review SystemGE Healthcare · Radiology
- TruPlan Computed Tomography (CT) Imaging SoftwareCircle Cardiovascular Imaging, Inc. · Radiology
- MR Diffusion Perfusion Mismatch V1.0Olea Medical · Radiology
- AIBOLIT 3D+Aibolit Technologies, LLC · Radiology
- TeraRecon NeuroTeraRecon, Inc · Radiology
- AI4CMR v1.0AI4MedImaging Medical Solutions S.A. · Radiology
- ElucidVivo A.3Elucid Bioimaging Inc. · Radiology
- SwiftMRAIRS Medical Inc. · Radiology
- Quantib ProstateQuantib BV · Radiology
- Segment 3DPrintMedviso AB · Radiology
- aPROMISE XEXINI Diagnostics AB · Radiology
- ClariPulmoClariPi Inc. · Radiology
- RapidiSchema View Inc. · Radiology
- Quantib NDQuantib B.V. · Radiology
- UNiD Spine AnalyzerMEDICREA International, Inc. · Radiology
- AIBOLIT 3D+AIbolit Technologies, LLC · Radiology
- FlightPlan for LiverGE Medical Systems SCS · Radiology
- SwiftMRAIRS Medical Inc. · Radiology
- RBkneeRadiobotics ApS · Radiology
- TruSPECT Radiological Image Processing StationSpectrum Dynamics Medical Ltd · Radiology
- aPROMISEEXINI Diagnostics AB · Radiology
- ClariCT.AIClariPi Inc. · Radiology
- Volpara Imaging SoftwareVolpara Health Technologies Limited · Radiology
- Qmenta Care Platform FamilyMint Labs, Inc., d/b/a. QMENTA · Radiology
- Overjet Dental AssistOverjet, Inc. · Radiology
- SIS System (Version 5.1.0)Surgical Information Sciences, Inc. · Radiology
- SubtleMRSubtle Medical, Inc. · Radiology
- NinesMeasureNines, Inc. · Radiology
- TruPlanCircle Cardiovascular Imaging Inc. · Radiology
- Synapse 3D, Synapse 3D Base Tools v6.1Fujifilm Corporation · Radiology
- QUIBIM Precision Prostate (qp-Prostate)QUIBIM S.L. · Radiology
- BrainInsightHyperfine Research, Inc · Radiology
- AI MetricsAI Metrics, LLC · Radiology
- HealthJOINTZebra Medical Vision Ltd. · Radiology
- CorInsights MRIADM Diagnostics, Inc. · Radiology
- PROViewGE Medical Systems SCS · Radiology
- Neuro.Al AlgorithmTeraRecon, Inc. · Radiology
- A View LCSCoreline Soft Co., Ltd. · Radiology
- Quantib ProstateQuantib BV · Radiology
- Cleerly Labs v2.0Cleerly, Inc. · Radiology
- THINQCorticoMetrics LLC · Radiology
- Xeleris V Processing and Review SystemsGE Healthcare · Radiology
- EchoPAC Software Only, EchoPAC Plug-InGE Medical Systems Ultrasound and Primary Care Diagnostics · Radiology
- AVA (Augmented Vascular Analysis)See-Mode Technologies Pte. Ltd. · Radiology
- AVIEWCoreline Soft Co., Ltd · Radiology
- TOMTEC-ARENATOMTEC Imaging Systems GmbH · Radiology
- Limbus ContourLimbus AI Inc. · Radiology
- AI-Rad Companion EngineSiemens Medical Solutions USA, Inc. · Radiology
- AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc. · Radiology
- AVIEW LCSCoreline Soft Co., Ltd · Radiology
- icobrain-ctpIcometrix NV · Radiology
- densitas densityaiDensitas, Inc. · Radiology
- ADAS 3DGalgo Medical S.L · Radiology
- QyScore SoftwareQynapse · Radiology
- IcobrainIcometrix NV · Radiology
- NemoScanSoftware Nemotec S.L. · Radiology
- PhantomMSK TraumaOrthoGrid Systems Inc. · Radiology
- RSI-MRI+MultiModal Imaging Services Corporation (dba HealthLytix) · Radiology
- MEDIP PROMEDICALIP Co., Ltd · Radiology
- Cleerly LabsCleerly Inc · Radiology
- KOALAIB Lab GmbH · Radiology
- Merge PACSMerge Healthcare Incorporated · Radiology
- Ventripoint Medical System Plus (VMS+) 3.0Ventripoint Diagnostics, Ltd. · Radiology
- SubtleMRSubtle Medical, Inc. · Radiology
- SIS Software Version 3.6.0Surgical Information Sciences, Inc. · Radiology
- D2P3D Systems, Inc. · Radiology
- aBSIEXINI Diagnostics AB · Radiology
- iNtuition-Structural Heart ModuleTeraRecon Inc. · Radiology
- ClariCT.AIClariPI Inc. · Radiology
- SurgicalARMEDIVIS, Inc. · Radiology
- Lung Vision SystemBody Vision Medical Ltd. · Radiology
- SIS Software version 3.3.0Surgical Information Sciences, Inc. · Radiology
- AI Rad Companion (Engine)Siemens Medical Solutions USA, Inc. · Radiology
- MRCP+ v1.0Perspectum Diagnostics Ltd · Radiology
- AmCAD-UOAmCad BioMed Corporation · Radiology
- Quantib NDQuantib BV · Radiology
- iSchemaView RAPIDiSchemaView, Inc. · Radiology
- vascuCAPElucid Bioimaging Inc. · Radiology
- Centricity Universal ViewerGE Healthcare · Radiology
- Vitrea CT Brain PerfusionVital Images, Inc. · Radiology
- icobrainicometrix NV · Radiology
- Arterys MICAArterys Inc. · Radiology
- Ziostation2Ziosoft, Inc. · Radiology
- Volpara Imaging SoftwareVolpara Health Technologies Limited · Radiology
- Quantitative Total Extensible Imaging (QTxI)AIQ Solutions, Inc. · Radiology
- DenSeeMammoStatlife · Radiology
- EchoMD Automated Ejection Fraction SoftwareBay Labs, Inc. · Radiology
- Viz CTPViz.ai, Inc. · Radiology
- Quantib BrainQuantib BV · Radiology
- iQMRMedic Vision - Imaging Solutions Ltd · Radiology
- DM-DensityDensitas, Inc. · Radiology
- UNiD Spine AnalyzerMedicrea International · Radiology
- Arterys Oncology DLArterys Inc. · Radiology
- Illumeo SystemPhilips Medical Systems Technologies, Ltd. · Radiology
- cNeuro cMRICombinostics Oy · Radiology
- Radiomics App v1.0Microsoft Corp. · Radiology
- Infinitt PACS 7.0Infinitt Healthcare Co.,Ltd. · Radiology
- QuantraHOLOGIC, INC. · Radiology
- NeuroQuantCorTechs Labs, Inc · Radiology
- syngo Application SoftwareSiemens Medical Solutions, USA, Inc. · Radiology
- SmartTargetSmartTarget, Ltd. · Radiology
- UNiD Spine AnalyzerMEDICREA INTERNATIONAL · Radiology
- Lung VisionBODY VISION MEDICAL LTD. · Radiology
- AmCAD-UVAmCad BioMed Corporation · Radiology
- SIS SoftwareSurgical Information Sciences, Inc. · Radiology
- Quantib Brain 1.2Quantib BV · Radiology
- Arterys Cardio DLARTERYS INC. · Radiology
- ClearView cCADClearView Diagnostics Inc. · Radiology
- CT CoPilotZEPMED, LLC. · Radiology
- PixelShineALGOMEDICA · Radiology
- icobrainIcometrix · Radiology
- LVivo Software ApplicationDIACARDIO, LTD. · Radiology
- Quantib Brain 1QUANTIB BV · Radiology
- Volpara Imaging SoftwareMatakina Technology LTD · Radiology
- QUANTRAHOLOGIC, INC. · Radiology
- CVI42CIRCLE CARDIOVASCULAR IMAGING INC · Radiology
- CLEARREAD +CONFIRMRIVERAIN TECHNOLOGIES · Radiology
- ALPHAPOINT IMAGING SOFTWARERADLOGICS, INC. · Radiology
- DELTAVIEW MODEL 2.1RIVERAIN MEDICAL GROUP,LLC · Radiology
- QUANTRAHOLOGIC, INC. · Radiology