FDA Product Code
FDA Product Code LLZ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.2050
510(k) Clearances — 2,293 records · page 1 of 23
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K263048 | Syngo Carbon Space (VA4) | Siemens Healthineers AG | 2026-09-29 | Traditional | PDF ↗ |
| K261874 | Syneris PACS v.1.0.1.0 | Syneris | 2026-09-23 | Traditional | PDF ↗ |
| K262442 | HipStudio Analysis | Replasia BV | 2026-09-22 | Traditional | PDF ↗ |
| K261855 | Elucid PlaqueIQ | Elucid Bioimaging, Inc. | 2026-09-18 | Traditional | PDF ↗ |
| K254214 | OOOPDS | Taiwan Main Orthopaedic Biotechnology Co., Ltd. | 2026-09-15 | Traditional | PDF ↗ |
| K261861 | SPINEsim v1.0 | Mdsim S.A. | 2026-09-15 | Traditional | PDF ↗ |
| K262060 | 3D-RD-S | Radiopharmaceutical Imaging & Dosimetry, LLC | 2026-09-04 | Traditional | PDF ↗ |
| K261500 | KBA3D (v2.4.0) | S.M.A.I.O | 2026-08-17 | Traditional | PDF ↗ |
| K262449 | AdvaView | ADVAHEALTH SOLUTIONS, LLC | 2026-08-14 | Special | PDF ↗ |
| K261916 | NeuroQuant PET | Cortechs Labs, Inc. | 2026-08-12 | Traditional | PDF ↗ |
| K260936 | RadioViewAI | Neurocareai, Inc. (Dba Savelife.Ai) | 2026-07-31 | Traditional | PDF ↗ |
| K260588 | Cleerly LABS | Cleerly, Inc. | 2026-07-29 | Traditional | PDF ↗ |
| K262462 | TheraSphere 360 Y-90 Management Platform | Boston Scientific Corporation | 2026-07-24 | Special | PDF ↗ |
| K262143 | ImageGrid StreamVue | Candelis, Inc. | 2026-07-23 | Traditional | PDF ↗ |
| K260500 | ResolutionMD | ResolutionMD, Inc. | 2026-07-21 | Traditional | PDF ↗ |
| K262120 | Avara Viewer | Avara Software | 2026-07-10 | Traditional | PDF ↗ |
| K253899 | 3D-Anywhere | Provect.AI | 2026-07-09 | Traditional | PDF ↗ |
| K261465 | INDIRA CLOUD VIEWER | INDIGO TECHNOLOGIES | 2026-07-06 | Traditional | PDF ↗ |
| K260576 | MeVis AVM Contour | MeVis Medical Solutions AG | 2026-06-30 | Traditional | PDF ↗ |
| K260231 | MiPACS V5 (1.0.0) | Apryse Software Corp | 2026-06-25 | Traditional | PDF ↗ |
| K253421 | Perfusion Measurement Platform v1 | Quantified Imaging Limited | 2026-06-22 | Traditional | PDF ↗ |
| K261352 | 2D Hip Planning Software | One Ortho | 2026-06-08 | Traditional | PDF ↗ |
| K260116 | CustoMED Viewer | CustoMED , Ltd. | 2026-06-03 | Traditional | PDF ↗ |
| K254265 | Helion Viewer Suite | Videomed Srl ( a Baxter Healthcare Corp company) | 2026-05-27 | Traditional | PDF ↗ |
| K253831 | CMN Capillary Function with Virtual Expert for MRI, CT and CBCT | Cercare Medical A/S | 2026-05-18 | Traditional | PDF ↗ |
| K254013 | SubtleHD-PET (1.x) | Subtle Medical, Inc. | 2026-05-14 | Traditional | PDF ↗ |
| K260321 | HipGuide (V 1.0.0.0) | Orthopedic Driven Imaging, LLC | 2026-05-08 | Traditional | PDF ↗ |
| K260716 | Neowise | Cefla S.C. | 2026-05-04 | Traditional | PDF ↗ |
| K260009 | LungPoint Virtual Bronchoscopic Navigation (VBN) Software | Broncus Medical, Inc. | 2026-04-24 | Traditional | PDF ↗ |
| K254237 | CCI PACS VIEWER (PACS-US-001) | CliniComp, Intl. | 2026-04-23 | Traditional | PDF ↗ |
| K253029 | RW-1 | Mediott, Inc. | 2026-03-31 | Traditional | PDF ↗ |
| K253950 | Avatar Medical Vision | Avatar Medical | 2026-03-30 | Traditional | PDF ↗ |
| K252195 | ARTICOR planner | Artiness S.R.L | 2026-03-27 | Traditional | PDF ↗ |
| K260479 | TheraSphere 360 Y-90 Management Platform | Boston Scientific Corporation | 2026-03-13 | Special | PDF ↗ |
| K253111 | Aeka Imaging | Good Methods Global, Inc. | 2026-03-13 | Traditional | PDF ↗ |
| K251964 | Mimics Thoracic Planner | Materialise NV | 2026-03-12 | Traditional | PDF ↗ |
| K253486 | SKIA-Head (Model: SKIA-ST00) | Skia, Inc. | 2026-02-23 | Traditional | PDF ↗ |
| K260205 | AS Software Version Asera | AS Software, LLC | 2026-02-19 | Special | PDF ↗ |
| K253927 | LiveMedica Enterprise PACS | Live Medica, LLC | 2026-02-06 | Traditional | PDF ↗ |
| K251577 | LAIA XR | Augmented Reality Software S.L. | 2026-02-06 | Traditional | PDF ↗ |
| K253639 | View | GE Healthcare | 2026-01-08 | Traditional | PDF ↗ |
| K253784 | 3DICOM MD Cloud | Singular Health Pty, Ltd. | 2026-01-08 | Traditional | PDF ↗ |
| K253008 | maiLink | Maihub Corp. | 2026-01-05 | Traditional | PDF ↗ |
| K251883 | MIM LesionID Pro | Mim Software, Inc. | 2025-12-11 | Traditional | PDF ↗ |
| K251880 | Archy Dental Imaging | Archy Dental, Inc. | 2025-11-21 | Traditional | PDF ↗ |
| K253495 | syngo.MR Applications (VB80) | Siemens Healthineers AG | 2025-11-20 | Traditional | PDF ↗ |
| K251410 | VXvue | Vieworks Co., Ltd. | 2025-11-04 | Traditional | PDF ↗ |
| K251532 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | Mighty Oak Medical | 2025-11-03 | Traditional | PDF ↗ |
| K252547 | TheraSphere 360 Y-90 Management Platform | Boston Scientific Corporation | 2025-10-28 | Traditional | PDF ↗ |
| K251030 | Sirona Advanced Imaging Suite | Sirona Medical | 2025-10-22 | Traditional | PDF ↗ |
| K252476 | Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout | Brainlab AG | 2025-10-16 | Special | PDF ↗ |
| K252199 | AGFA HealthCare Enterprise Imaging | Agfa Healthcare N.V. | 2025-10-15 | Traditional | PDF ↗ |
| K251363 | ProKnow DS | Elekta Solutions AB | 2025-10-08 | Traditional | PDF ↗ |
| K250039 | HPACS | Healthhub | 2025-10-03 | Traditional | PDF ↗ |
| K251215 | Philips IntelliSpace Cardiovascular | Philips Medical Systems Nederland B.V. | 2025-10-02 | Traditional | PDF ↗ |
| K250045 | uWS-Angio Pro | Shanghai United Imaging Healthcare Co., Ltd. | 2025-09-24 | Traditional | PDF ↗ |
| K250040 | uWS-Angio | Shanghai United Imaging Healthcare Co., Ltd. | 2025-09-12 | Traditional | PDF ↗ |
| K242314 | Minimally Invasive Prostate Surgery Navigation System(Model:AmaKris SR1-A-2) | Augment Intelligent Medical System (China) Co., Ltd. | 2025-09-11 | Traditional | PDF ↗ |
| K252608 | AI-Rad Companion Prostate MR | Siemens Healthcare GmbH | 2025-09-09 | Traditional | PDF ↗ |
| K251168 | Image Suite | Carestream Health, Inc. | 2025-09-04 | Traditional | PDF ↗ |
| K250290 | SurgiTwin | Twinsight | 2025-08-29 | Traditional | PDF ↗ |
| K252526 | Rapid DeltaFuse | Ischemaview, Inc. | 2025-08-26 | Traditional | PDF ↗ |
| K243680 | Neurovascular Insight V1.0 | Olea Medical S.A.S. | 2025-08-25 | Traditional | PDF ↗ |
| K232456 | RW-1 | Mediott, Inc. | 2025-08-11 | Traditional | PDF ↗ |
| K250664 | Navigo Workstation 2.3 (FPRMC00039) | UC-CARE , Ltd. | 2025-08-07 | Traditional | PDF ↗ |
| K251038 | Digital Radiographic Imaging Acquisition Software - DR (RiasDR) | Shen Zhen Cambridge-Hit Co., Ltd. | 2025-08-06 | Traditional | PDF ↗ |
| K244016 | iPETcertum (v1.0) | Claritas Healthtech Pte, Ltd. | 2025-08-05 | Traditional | PDF ↗ |
| K250716 | IMAGE ONE | Infomed Software, S.L. | 2025-07-23 | Traditional | PDF ↗ |
| K243681 | Neuro Insight V1.0 | Olea Medical S.A.S. | 2025-07-23 | Traditional | PDF ↗ |
| K250686 | GyriCalc (Version 1.0.0) | Neurospectrum Insights Corp. | 2025-07-22 | Traditional | PDF ↗ |
| K250181 | AV Viewer | Philips Medical Systems Nederland B.V. | 2025-07-15 | Traditional | PDF ↗ |
| K250120 | GECHO | Narnar, LLC | 2025-07-14 | Traditional | PDF ↗ |
| K251863 | CustomSurg OrthoPlanner | Customsurg AG | 2025-07-07 | Traditional | PDF ↗ |
| K243666 | uOmniscan | Shanghai United Imaging Healthcare Co., Ltd. | 2025-06-17 | Traditional | PDF ↗ |
| K244012 | Mosaic (V1.0.1) | Navier Medical | 2025-06-16 | Traditional | PDF ↗ |
| K243703 | TechLive | DeepHealth, Inc. | 2025-06-05 | Traditional | PDF ↗ |
| K250800 | UroNav 4 | Philips DS North America, LLC | 2025-06-05 | Traditional | PDF ↗ |
| K251109 | SMARTDent | Ray Co., Ltd. | 2025-05-21 | Traditional | PDF ↗ |
| K243632 | uWS-Angio Basic | Shanghai United Imaging Healthcare Co., Ltd. | 2025-05-12 | Traditional | PDF ↗ |
| K243069 | LUMYS (V1) | Intradys | 2025-05-02 | Traditional | PDF ↗ |
| K243697 | MySpine WebPlanner | Medacta International S.A. | 2025-04-23 | Traditional | PDF ↗ |
| K243651 | VersaViewer | GE Medical Systems SCS | 2025-04-21 | Traditional | PDF ↗ |
| K242647 | MySegmenter (v2.0.0) | Mysegmenter Technologies, Inc. | 2025-04-16 | Traditional | PDF ↗ |
| K250301 | Merge Universal Viewer (MUV) | Merge Healthcare Incorporated | 2025-04-14 | Traditional | PDF ↗ |
| K242552 | Horos Mobile | Icat Solutions, Ltd. | 2025-04-08 | Traditional | PDF ↗ |
| K243292 | brAIn Shoulder Positioning | Avatar Medical | 2025-03-20 | Traditional | PDF ↗ |
| K242161 | Radlink GPS Pro Imaging | Radlink, Inc. | 2025-03-18 | Traditional | PDF ↗ |
| K241975 | SERV MEDICAL CDSS | Serv Medical Pte., Ltd. | 2025-03-17 | Traditional | PDF ↗ |
| K241765 | PLANET Onco Dose (3.2) | Dosisoft SA | 2025-03-14 | Traditional | PDF ↗ |
| K241546 | aiCockpit AI Viewer | Fovia, Inc. | 2025-02-26 | Traditional | PDF ↗ |
| K250348 | JLK-AILink | JLK, Inc. | 2025-02-25 | Traditional | PDF ↗ |
| K242838 | QuickRad | Aikenist Technologies Pvt, Ltd. | 2025-02-21 | Traditional | PDF ↗ |
| K242240 | CaRi-Plaque | Caristo Diagnostics , Ltd. | 2025-02-20 | Traditional | PDF ↗ |
| K241425 | AspenView | Aspen Imaging Healthcare, Inc. | 2025-02-12 | Traditional | PDF ↗ |
| K243333 | rTOP | Roclub GmbH | 2025-02-04 | Traditional | PDF ↗ |
| K241694 | ZeTTA PACS | Tae Young Soft Co., Ltd. | 2025-01-31 | Traditional | PDF ↗ |
| K241819 | CephNinja | Cyncronus, LLC | 2025-01-23 | Traditional | PDF ↗ |
| K242205 | SpectoMed (v1.0) | Specto Medical | 2025-01-14 | Traditional | PDF ↗ |
| K241808 | ApolloHipX (THR.SS.0001) | Corin U.S.A. Limited | 2025-01-07 | Traditional | PDF ↗ |
| K242123 | Brainomix 360 e-CTA | Brainomix Limited | 2025-01-06 | Traditional | PDF ↗ |
Product code LLZ · Class II · Radiology. Data: openFDA.