LLZ
- Product code
- LLZ
- Device name
- System, Image Processing, Radiological
- Device class
- Class 2
- 21 CFR
- 21 CFR 892.2050
- Medical specialty
- Radiology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 177
- Summaries archived here
- 154 (direct download)
- 510(k) clearances (all years, FDA)
- 2286 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (177)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261500 | 2026-08-17 | S.M.A.I.O | KBA3D (v2.4.0) | |
| K262449 | 2026-08-14 | ADVAHEALTH SOLUTIONS, LLC | AdvaView | |
| K261916 | 2026-08-12 | Cortechs Labs, Inc. | NeuroQuant PET | |
| K260936 | 2026-07-31 | Neurocareai, Inc. (Dba Savelife.Ai) | RadioViewAI | |
| K260588 | 2026-07-29 | Cleerly, Inc. | Cleerly LABS | |
| K262462 | 2026-07-24 | Boston Scientific Corporation | TheraSphere 360 Y-90 Management Platform | |
| K262143 | 2026-07-23 | Candelis, Inc. | ImageGrid StreamVue | |
| K260500 | 2026-07-21 | ResolutionMD, Inc. | ResolutionMD | |
| K262120 | 2026-07-10 | Avara Software | Avara Viewer | |
| K253899 | 2026-07-09 | Provect.AI | 3D-Anywhere | |
| K261465 | 2026-07-06 | INDIGO TECHNOLOGIES | INDIRA CLOUD VIEWER | |
| K260576 | 2026-06-30 | MeVis Medical Solutions AG | MeVis AVM Contour | |
| K260231 | 2026-06-25 | Apryse Software Corp | MiPACS V5 (1.0.0) | |
| K253421 | 2026-06-22 | Quantified Imaging Limited | Perfusion Measurement Platform v1 | |
| K261352 | 2026-06-08 | One Ortho | 2D Hip Planning Software | |
| K260116 | 2026-06-03 | CustoMED , Ltd. | CustoMED Viewer | |
| K254265 | 2026-05-27 | Videomed Srl ( a Baxter Healthcare Cor… | Helion Viewer Suite | |
| K253831 | 2026-05-18 | Cercare Medical A/S | CMN Capillary Function with Virtual Expert for MRI, … | |
| K254013 | 2026-05-14 | Subtle Medical, Inc. | SubtleHD-PET (1.x) | |
| K260321 | 2026-05-08 | Orthopedic Driven Imaging, LLC | HipGuide (V 1.0.0.0) | |
| K260716 | 2026-05-04 | Cefla S.C. | Neowise | FDA |
| K260009 | 2026-04-24 | Broncus Medical, Inc. | LungPoint Virtual Bronchoscopic Navigation (VBN) Sof… | |
| K254237 | 2026-04-23 | CliniComp, Intl. | CCI PACS VIEWER (PACS-US-001) | |
| K253029 | 2026-03-31 | Mediott, Inc. | RW-1 | |
| K253950 | 2026-03-30 | Avatar Medical | Avatar Medical Vision | |
| K252195 | 2026-03-27 | Artiness S.R.L | ARTICOR planner | |
| K260479 | 2026-03-13 | Boston Scientific Corporation | TheraSphere 360 Y-90 Management Platform | |
| K253111 | 2026-03-13 | Good Methods Global, Inc. | Aeka Imaging | |
| K251964 | 2026-03-12 | Materialise NV | Mimics Thoracic Planner | |
| K253486 | 2026-02-23 | Skia, Inc. | SKIA-Head (Model: SKIA-ST00) | |
| K260205 | 2026-02-19 | AS Software, LLC | AS Software Version Asera | |
| K253927 | 2026-02-06 | Live Medica, LLC | LiveMedica Enterprise PACS | |
| K251577 | 2026-02-06 | Augmented Reality Software S.L. | LAIA XR | |
| K253784 | 2026-01-08 | Singular Health Pty, Ltd. | 3DICOM MD Cloud | FDA |
| K253639 | 2026-01-08 | GE Healthcare | View | FDA |
| K253008 | 2026-01-05 | Maihub Corp. | maiLink | FDA |
| K251883 | 2025-12-11 | Mim Software, Inc. | MIM LesionID Pro | |
| K251880 | 2025-11-21 | Archy Dental, Inc. | Archy Dental Imaging | |
| K253495 | 2025-11-20 | Siemens Healthineers AG | syngo.MR Applications (VB80) | |
| K251410 | 2025-11-04 | Vieworks Co., Ltd. | VXvue | |
| K251532 | 2025-11-03 | Mighty Oak Medical | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC… | |
| K252547 | 2025-10-28 | Boston Scientific Corporation | TheraSphere 360 Y-90 Management Platform | |
| K251030 | 2025-10-22 | Sirona Medical | Sirona Advanced Imaging Suite | |
| K252476 | 2025-10-16 | Brainlab AG | Viewer (5.4); Elements Viewer; Mixed Reality Viewer;… | |
| K252199 | 2025-10-15 | Agfa Healthcare N.V. | AGFA HealthCare Enterprise Imaging | |
| K251363 | 2025-10-08 | Elekta Solutions AB | ProKnow DS | |
| K250039 | 2025-10-03 | Healthhub | HPACS | |
| K251215 | 2025-10-02 | Philips Medical Systems Nederland B.V. | Philips IntelliSpace Cardiovascular | |
| K250045 | 2025-09-24 | Shanghai United Imaging Healthcare Co.… | uWS-Angio Pro | |
| K250040 | 2025-09-12 | Shanghai United Imaging Healthcare Co.… | uWS-Angio | |
| K242314 | 2025-09-11 | Augment Intelligent Medical System (Ch… | Minimally Invasive Prostate Surgery Navigation Syste… | |
| K252608 | 2025-09-09 | Siemens Healthcare GmbH | AI-Rad Companion Prostate MR | FDA |
| K251168 | 2025-09-04 | Carestream Health, Inc. | Image Suite | |
| K250290 | 2025-08-29 | Twinsight | SurgiTwin | FDA |
| K252526 | 2025-08-26 | Ischemaview, Inc. | Rapid DeltaFuse | FDA |
| K243680 | 2025-08-25 | Olea Medical S.A.S. | Neurovascular Insight V1.0 | |
| K232456 | 2025-08-11 | Mediott, Inc. | RW-1 | |
| K250664 | 2025-08-07 | UC-CARE , Ltd. | Navigo Workstation 2.3 (FPRMC00039) | |
| K251038 | 2025-08-06 | Shen Zhen Cambridge-Hit Co., Ltd. | Digital Radiographic Imaging Acquisition Software - … | |
| K244016 | 2025-08-05 | Claritas Healthtech Pte, Ltd. | iPETcertum (v1.0) | |
| K243681 | 2025-07-23 | Olea Medical S.A.S. | Neuro Insight V1.0 | |
| K250716 | 2025-07-23 | Infomed Software, S.L. | IMAGE ONE | |
| K250686 | 2025-07-22 | Neurospectrum Insights Corp. | GyriCalc (Version 1.0.0) | |
| K250181 | 2025-07-15 | Philips Medical Systems Nederland B.V. | AV Viewer | |
| K250120 | 2025-07-14 | Narnar, LLC | GECHO | |
| K251863 | 2025-07-07 | Customsurg AG | CustomSurg OrthoPlanner | FDA |
| K243666 | 2025-06-17 | Shanghai United Imaging Healthcare Co.… | uOmniscan | |
| K244012 | 2025-06-16 | Navier Medical | Mosaic (V1.0.1) | |
| K243703 | 2025-06-05 | DeepHealth, Inc. | TechLive | |
| K250800 | 2025-06-05 | Philips DS North America, LLC | UroNav 4 | |
| K251109 | 2025-05-21 | Ray Co., Ltd. | SMARTDent | |
| K243632 | 2025-05-12 | Shanghai United Imaging Healthcare Co.… | uWS-Angio Basic | |
| K243069 | 2025-05-02 | Intradys | LUMYS (V1) | |
| K243697 | 2025-04-23 | Medacta International S.A. | MySpine WebPlanner | |
| K243651 | 2025-04-21 | GE Medical Systems SCS | VersaViewer | |
| K242647 | 2025-04-16 | Mysegmenter Technologies, Inc. | MySegmenter (v2.0.0) | |
| K250301 | 2025-04-14 | Merge Healthcare Incorporated | Merge Universal Viewer (MUV) | |
| K242552 | 2025-04-08 | Icat Solutions, Ltd. | Horos Mobile | |
| K243292 | 2025-03-20 | Avatar Medical | brAIn Shoulder Positioning | |
| K242161 | 2025-03-18 | Radlink, Inc. | Radlink GPS Pro Imaging | FDA |
| K241975 | 2025-03-17 | Serv Medical Pte., Ltd. | SERV MEDICAL CDSS | |
| K241765 | 2025-03-14 | Dosisoft SA | PLANET Onco Dose (3.2) | |
| K241546 | 2025-02-26 | Fovia, Inc. | aiCockpit AI Viewer | |
| K250348 | 2025-02-25 | JLK, Inc. | JLK-AILink | |
| K242838 | 2025-02-21 | Aikenist Technologies Pvt, Ltd. | QuickRad | |
| K242240 | 2025-02-20 | Caristo Diagnostics , Ltd. | CaRi-Plaque | |
| K241425 | 2025-02-12 | Aspen Imaging Healthcare, Inc. | AspenView | |
| K243333 | 2025-02-04 | Roclub GmbH | rTOP | |
| K241694 | 2025-01-31 | Tae Young Soft Co., Ltd. | ZeTTA PACS | |
| K241819 | 2025-01-23 | Cyncronus, LLC | CephNinja | |
| K242205 | 2025-01-14 | Specto Medical | SpectoMed (v1.0) | FDA |
| K241808 | 2025-01-07 | Corin U.S.A. Limited | ApolloHipX (THR.SS.0001) | |
| K242123 | 2025-01-06 | Brainomix Limited | Brainomix 360 e-CTA | |
| K241350 | 2025-01-03 | Ge Medical Systems Israel, Functional … | Clarify DL | |
| K242599 | 2024-12-20 | Carlsmed, Inc. | aprevo® Digital Planning | |
| K242362 | 2024-12-20 | Nexsys Electronics Inc. Dba Medweb | Lightning Viewer | |
| K241989 | 2024-12-06 | Cercare Medical A/S | Cercare Medical Neurosuite (CMN) Capillary Function … | |
| K240926 | 2024-12-06 | Peek Health, S.A. | PeekMed web | |
| K243447 | 2024-12-05 | Navbit Pty, Ltd. | Rapid Surgical Plan (RSP-SW-001) | |
| K242810 | 2024-11-26 | Radunity Corp. | RadUnity (Version 1.0.0) | |
| K241495 | 2024-11-21 | Jazz Imaging | Jazz Classic | |
| K242329 | 2024-11-18 | Philips Healthcare (Suzhou) Co., Ltd. | CT Collaboration Live | |
| K242062 | 2024-11-15 | Mycardium AI Limited | 1CMR Pro | |
| K241981 | 2024-11-12 | Change Healthcare Canada Company | Change Healthcare Stratus Imaging PACS | |
| K242709 | 2024-11-04 | JLK, Inc. | JLK-PWI | FDA |
| K241223 | 2024-10-31 | Erad, Inc. | eRAD PACS | |
| K242512 | 2024-10-24 | Philips Medical Systems Nederland B.V. | ROCC Console | FDA |
| K243012 | 2024-10-23 | Mim Software, Inc. | MIM Symphony HDR Fusion | |
| K243209 | 2024-10-22 | Nordicneurolab AS | nordicMEDiVA | |
| K242556 | 2024-10-16 | JLK, Inc. | JLK-CTP | |
| K240385 | 2024-10-15 | Mediimg Corporation | VINT | FDA |
| K241569 | 2024-10-11 | Siemens Medical Solutions USA, Inc. | syngo Application Software | |
| K240243 | 2024-09-23 | DRTECH Corporation | EConsole2 | |
| K241524 | 2024-09-12 | Elucid Bioimaging, Inc. | Elucid PlaqueIQ | |
| K233998 | 2024-09-05 | Aiq Global, Inc. | TRAQinform IQ | FDA |
| K241302 | 2024-08-23 | Samsung Medison Co., Ltd. | SonoSync | |
| K240290 | 2024-08-21 | Subtle Medical, Inc. | AiMIFY (1.x) | |
| K241094 | 2024-08-13 | Turing Medical Technologies, Inc. | Bullsai | |
| K240724 | 2024-08-08 | Synthesis Health Intelligence, Inc. | SynthVISION 1.0.0 | |
| K233761 | 2024-08-05 | Longwood Valley Medical , Ltd. | Orthopaedic Surgery Planning Software (AIJOINT) | |
| K241114 | 2024-07-23 | Ewoosoft Co., Ltd. | EzDent-i / E2 / Prora View / Smart M Viewer (v3.5) | |
| K241879 | 2024-07-18 | Virtual Radiologic Corporation | vRad Viewer | |
| K241121 | 2024-07-17 | Microstructure Imaging, Inc. | MICSI-RMT | |
| K240705 | 2024-07-17 | Canon Medical Systems Corporation | Vitrea Software Package, VSTP-002A V2.0 | |
| K241300 | 2024-07-02 | Ge Healthcare GmbH | ViewPoint 6 | |
| K233908 | 2024-07-01 | Combinostics OY | cNeuro cDAT | |
| K241608 | 2024-06-28 | Nordicneurolab AS | nordicMEDiVA | |
| K233331 | 2024-06-17 | Pmx, Inc. | MediOMx | |
| K223427 | 2024-05-31 | Materialise NV | Mimics Enlight CMF | |
| K240281 | 2024-05-31 | Konica Minolta, Inc. | Bone Suppression Software | |
| K240294 | 2024-05-23 | Siemens Healthcare GmbH | Syngo Carbon Enterprise Access (VA40A) | |
| K232759 | 2024-05-21 | Brainlab AG | Viewer (5.4); Elements Viewer; Mixed Reality Viewer;… | FDA |
| K233620 | 2024-05-20 | Mim Software, Inc. | MIM - Centiloid Scaling | |
| K232862 | 2024-05-13 | Mim Software, Inc. | MIM Monte Carlo Dosimetry | |
| K232976 | 2024-05-09 | Vuze Medical , Ltd. | VUZE System | |
| K232514 | 2024-05-06 | Mim Software, Inc. | MIM Dose Analysis | |
| K233699 | 2024-04-29 | Subtle Medical, Inc. | SubtleREFORMAT (1.x) | |
| K240822 | 2024-04-24 | Philips Medical Systems Technologies | Image Management V15 | |
| K240839 | 2024-04-24 | Openrad Services Uk, Ltd. | OpenRad Cloud | |
| K233582 | 2024-04-22 | Ischemaview, Inc. | Rapid | FDA |
| K232641 | 2024-04-10 | Everrtech Software Pvt, Ltd. | Neorad Pacs (Neorad Pacs) | |
| K232891 | 2024-03-27 | Carpl Ai, Inc. | CARPL (CARPL) | |
| K240620 | 2024-03-25 | Medical Templates AG | Cube Navigator | FDA |
| K233660 | 2024-03-18 | Ionic Health | nCommand Lite System | |
| K233599 | 2024-03-18 | Lg Electronics.Inc | X-Clever (ASHK100G) | FDA |
| K233930 | 2024-03-13 | Perspectum | MRCP+ version 2 (MRCP+ v2) | |
| K233572 | 2024-03-06 | Pymedix | Autofuse | |
| K233217 | 2024-02-12 | Materialise NV | Mimics Cardiac Planner | |
| K231662 | 2024-02-08 | Iaid | Aid-U | |
| K232339 | 2024-02-01 | Sira Medical, Inc. | Augmented Reality Application | |
| K232007 | 2024-02-01 | Pie Medical Imaging BV | CAAS MR Solutions | FDA |
| K231396 | 2024-01-31 | Orca Dental AI , Ltd. | CEPHX- Cephalometric Analysis Software | |
| K233714 | 2024-01-25 | GE Medical Systems SCS | BreView | |
| K231607 | 2024-01-24 | Axial Medical Printing Limited | Axial3D Cloud Segmentation Service | |
| K233226 | 2024-01-17 | Radical Imaging, LLC | FlexView Diagnostic (v1.1.20) | |
| K232589 | 2024-01-03 | Icat Solutions, Ltd. | Horos MD | |
| K232744 | 2023-12-21 | Siemens Healthcare GmbH | syngo Virtual Cockpit (VB10A) | FDA |
| K233176 | 2023-12-20 | Shanghai United Imaging Healthcare Co.… | uOmnispace.MI | |
| K230955 | 2023-12-20 | Siemens Medical Solutions USA, Inc. | syngo Application Software | |
| K231570 | 2023-12-14 | Nico-Lab B.V. | StrokeViewer Perfusion | |
| K233634 | 2023-12-12 | Bb Imaging | TeleScan | |
| K231898 | 2023-12-08 | Nobel Biocare AB | DTX Studio Clinic (4.0) | |
| K232661 | 2023-12-07 | Circle Cardiovascular Imaging | Myocardial Strain Software Application | FDA |
| K231498 | 2023-11-20 | Brainlab , Ltd. | TraumaCad Neo | |
| K230856 | 2023-11-14 | Brainspec, Inc. | BrainSpec Core Software | |
| K230854 | 2023-10-27 | Airs Medical, Inc. | SwiftMR | |
| K232086 | 2023-10-24 | Eos Imaging | spineEOS | |
| K223909 | 2023-10-20 | Megagen Implant Co., Ltd. | R2GATE Lite TM | |
| K231225 | 2023-10-18 | DRTECH Corporation | EConsole1 | |
| K230249 | 2023-10-16 | Immersivetouch | Ikshana | |
| K231642 | 2023-10-13 | Heuron Co., Ltd. | Veuron-Brain-pAb3 | |
| K230252 | 2023-09-26 | Orthofix US, LLC | OFIX MIS App | |
| K223659 | 2023-09-22 | Ai Medical AG | Jazz | |
| K231385 | 2023-09-20 | Rology, Inc. | Rology Teleradiology Platform (v.1.22.1103) | |
| K232189 | 2023-09-14 | Hoth Intelligence, Inc. | OrionXR | |
| K220034 | 2023-09-14 | In-Med Prognostics L3c | NEUROShield | — |
| K231353 | 2023-09-14 | ArteryFlow Technology Co., Ltd. | AccuCTP Pro | FDA |
Official FDA classification page: LLZ
Classification and pathway per current FDA publications. Data from openFDA (CC0).