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 4 of 23
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K211713 | AngioCloud Service | Angiocloud, LLC | 2022-04-28 | Traditional | PDF ↗ |
| K212981 | MirrorMe3D Modeling System | Mirrorme3D, LLC | 2022-04-22 | Traditional | PDF ↗ |
| K220779 | XD | Mirada Medical, Ltd. | 2022-04-15 | Traditional | PDF ↗ |
| K220767 | TeleScan | Bb Imaging | 2022-04-14 | Traditional | PDF ↗ |
| K203783 | ClariPulmo | Claripi, Inc. | 2022-04-06 | Traditional | PDF ↗ |
| K213562 | DTX Studio Clinic 3.0 | Nobel Biocare AB | 2022-03-25 | Traditional | PDF ↗ |
| K212040 | RI.HIP MODELER | Blue Belt Technologies, Inc. | 2022-03-11 | Traditional | PDF ↗ |
| K212720 | nordicDSC | Nordicneurolab AS | 2022-03-03 | Traditional | PDF ↗ |
| K220003 | EzOrtho v1.3 | Ewoosoft Co., Ltd. | 2022-02-23 | Traditional | PDF ↗ |
| K213165 | Rapid | Ischemaview, Inc. | 2022-02-08 | Traditional | PDF ↗ |
| K213801 | Veuron-Brain-pAb2 | Heuron Co., Ltd. | 2022-02-04 | Traditional | PDF ↗ |
| K213737 | Quantib ND | Quantib B.V. | 2022-01-14 | Special | PDF ↗ |
| K212005 | UNiD Spine Analyzer | Medicrea International, Inc. | 2022-01-12 | Traditional | PDF ↗ |
| K211443 | AIBOLIT 3D+ | Aibolit Technologies, LLC | 2022-01-07 | Traditional | PDF ↗ |
| K210830 | VUZE System | Vuze Medical , Ltd. | 2022-01-03 | Traditional | PDF ↗ |
| K211156 | CONVIVO In Vivo Pathology Suite | Carl Zeiss Meditec, AG | 2021-12-29 | Traditional | PDF ↗ |
| K213140 | Claritas iPET | Claritas Healthtech Pte, Ltd. | 2021-12-22 | Traditional | PDF ↗ |
| K210931 | Libby IAAA v1.0 | Dyad Medical, Inc. | 2021-12-17 | Traditional | PDF ↗ |
| K212420 | Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking, Brainlab Elements Image Fusion, Brainlab Elements Image Fusion Angio | Brainlab AG | 2021-12-16 | Traditional | PDF ↗ |
| K211039 | BIT-Motion | Dde Mri Solutions, Ltd. | 2021-12-15 | Traditional | PDF ↗ |
| K211114 | Will3D | Hdx Will Corp. | 2021-12-15 | Traditional | PDF ↗ |
| K212137 | X-Clever | Lg Electronics.Inc | 2021-12-10 | Traditional | PDF ↗ |
| K203743 | EXA | Konica Minolta Healthcare Americas, Inc. | 2021-12-10 | Special | PDF ↗ |
| K210241 | ImplaStation | Prodigident, Inc. | 2021-12-03 | Traditional | PDF ↗ |
| K210916 | PVmed Contouring Software | Perception Vision Medical Technologies Ltd.Co. | 2021-12-03 | Traditional | PDF ↗ |
| K211432 | Myomics Q | Phantomics, Inc. | 2021-11-23 | Traditional | PDF ↗ |
| K212621 | MAMMOVISTA B.smart | Siemens Medical Solutions USA, Inc. | 2021-11-12 | Traditional | PDF ↗ |
| K211876 | Intellijoint VIEW | Intellijoint Surgical, Inc. | 2021-11-12 | Traditional | PDF ↗ |
| K212984 | MiPACS HTML5 Web Viewer | Lead Technologies, Inc. | 2021-11-12 | Traditional | PDF ↗ |
| K210344 | inVisionOS | Precisionos Technology, Inc. | 2021-11-10 | Traditional | PDF ↗ |
| K212887 | RTapp | Segana, Inc. | 2021-11-10 | Traditional | PDF ↗ |
| K212550 | Hura CTP v1.0 | Hura Imaging, Inc. | 2021-11-08 | Traditional | PDF ↗ |
| K211356 | GIQuant | Motilent, Ltd. | 2021-11-08 | Traditional | PDF ↗ |
| K212896 | Visible Patient Suite | Visible Patient, Sas | 2021-11-05 | Traditional | PDF ↗ |
| K213326 | VisionX 3.0 | Durr Dental SE | 2021-11-02 | Special | PDF ↗ |
| K211987 | ATEC Alignment App | Alphatec Spine, Inc. | 2021-10-29 | Traditional | PDF ↗ |
| K210807 | FlightPlan for Liver | GE Medical Systems SCS | 2021-10-22 | Traditional | PDF ↗ |
| K212470 | iRAD | Claritas Healthtech Pte, Ltd. | 2021-10-20 | Traditional | PDF ↗ |
| K212528 | Change Healthcare Cardiology | Change Healthcare Israel , Ltd. | 2021-10-18 | Traditional | PDF ↗ |
| K202808 | Brainance MD | Advantis Medical Imaging Single Member P.C. | 2021-10-14 | Traditional | PDF ↗ |
| K210999 | SwiftMR | Airs Medical, Inc. | 2021-10-14 | Traditional | PDF ↗ |
| K211429 | NAVIPLAN - CT Planning Software for Total Hip Replacement | Naviswiss AG | 2021-10-05 | Traditional | PDF ↗ |
| K211795 | EzDent-i/ E2/ Prora View/ Smart M Viewer | Ewoosoft Co., Ltd. | 2021-10-04 | Traditional | PDF ↗ |
| K210726 | ImmersiveTouch | Immersivetouch, Inc. | 2021-09-29 | Traditional | PDF ↗ |
| K211700 | EzDent Web | Ewoosoft Co., Ltd. | 2021-09-28 | Traditional | PDF ↗ |
| K212777 | Collaboration Live | Philips Ultrasound, Inc. | 2021-09-24 | Special | PDF ↗ |
| K212321 | JiveX (Model Number / Release: 5.3) | Visus Health IT GmbH | 2021-09-23 | Traditional | PDF ↗ |
| K212685 | KONICAMINOLTA DI-X1 | Konica Minolta, Inc. | 2021-09-13 | Special | PDF ↗ |
| K211257 | EFAI PACS Picture Archiving and Communication System | Ever Fortune.Ai, Co., Ltd. | 2021-09-10 | Traditional | PDF ↗ |
| K202056 | Kinepict Medical Imaging Tool 4.0 | Kinepict Health, Ltd. | 2021-09-10 | Traditional | PDF ↗ |
| K212421 | ADAS 3D | Adas3D Medical S.L. | 2021-09-03 | Special | PDF ↗ |
| K203696 | RBknee | Radiobotics Aps | 2021-08-27 | Traditional | PDF ↗ |
| K211793 | EzOrtho | Ewoosoft Co., Ltd. | 2021-08-23 | Traditional | PDF ↗ |
| K211791 | Ez3D-i/E3 | Ewoosoft Co., Ltd. | 2021-08-20 | Traditional | PDF ↗ |
| K210998 | ROSA Hip System | Orthosoft D/B/A Zimmer Cas | 2021-08-17 | Traditional | PDF ↗ |
| K201573 | Brain Perfusion (BP) application | Philips Medical Systems Nederland B.V. | 2021-08-17 | Traditional | PDF ↗ |
| K212230 | TruSPECT Radiological Image Processing Station | Spectrum Dynamics Medical, Ltd. | 2021-08-16 | Special | PDF ↗ |
| K211863 | eVolve PACS | Evolve Pacs, Inc. | 2021-08-12 | Traditional | PDF ↗ |
| K212175 | DynaCAD | Invivo Corporation | 2021-08-02 | Abbreviated | PDF ↗ |
| K212074 | ClariCT.AI | Claripi, Inc. | 2021-07-27 | Special | PDF ↗ |
| K211655 | aPROMISE | Exini Diagnostics AB | 2021-07-27 | Traditional | PDF ↗ |
| K211279 | Volpara Imaging Software | Volpara Health Technologies Limited | 2021-07-27 | Special | PDF ↗ |
| K211386 | MySpine WebPlanner & MyBalance | Medacta International S.A. | 2021-07-23 | Traditional | PDF ↗ |
| K203765 | ZIRKONZAHN.Implant-Planner, ZIRKONZAHN.Implant-Planner Practice, CAD/CAM STL Converter, CAD/CAM Z-Tray | Zirkonzahn Srl | 2021-07-20 | Traditional | PDF ↗ |
| K201835 | PRE-SURE | Lazarus 3D, Inc. | 2021-07-08 | Traditional | PDF ↗ |
| K211480 | NubeX | Techheim Co., Ltd. | 2021-07-08 | Traditional | PDF ↗ |
| K210653 | ONE Planner Hip | Orthosoft D/B/A Zimmer Cas | 2021-07-07 | Traditional | PDF ↗ |
| K211656 | 3D Echo v1.1 | Jointvue, LLC | 2021-06-25 | Traditional | PDF ↗ |
| K202718 | Qmenta Care Platform Family | Mint Labs, Inc., D/B/A. Qmenta | 2021-06-16 | Traditional | PDF ↗ |
| K200704 | ZedView | Lexi Co., Ltd. | 2021-05-27 | Traditional | PDF ↗ |
| K211312 | Universal Viewer | GE Healthcare | 2021-05-21 | Special | PDF ↗ |
| K210257 | Xoran Workstation, Model 10050 | Xoran Technologies, LLC | 2021-05-20 | Traditional | PDF ↗ |
| K210187 | Overjet Dental Assist | Overjet, Inc. | 2021-05-19 | Traditional | PDF ↗ |
| K202793 | Cercare Medical Neurosuite | Cercare Medical Aps | 2021-05-17 | Traditional | PDF ↗ |
| K210072 | HOLOSCOPE-i | Real View Imaging , Ltd. | 2021-05-14 | Traditional | PDF ↗ |
| K210066 | ImagePilot | Konica Minolta, Inc. | 2021-05-06 | Special | PDF ↗ |
| K210682 | SOTA Cloud Imaging | Sota Precision Optics, Inc. Dba Sota Imaging | 2021-05-04 | Traditional | PDF ↗ |
| K202521 | PtoleMedic System | Lento Medical Innovation, Inc. | 2021-05-04 | Traditional | PDF ↗ |
| K202084 | DeepLook PRECISE | Deeplook, Inc. | 2021-04-09 | Traditional | PDF ↗ |
| K210850 | ADAS 3D | Adas3D Medical S.L. | 2021-04-05 | Special | PDF ↗ |
| K203195 | Simpleware ScanIP Medical | Synopsys (Northern Europe) , Ltd. | 2021-04-01 | Traditional | PDF ↗ |
| K210071 | SIS System (Version 5.1.0) | Surgical Information Sciences, Inc. | 2021-03-31 | Traditional | PDF ↗ |
| K203518 | Quicktome | Omniscient Neurotechnology Pty Ltd (O8t) | 2021-03-09 | Traditional | PDF ↗ |
| K203651 | Cuptimize | Cuptimize, Inc. | 2021-02-26 | Traditional | PDF ↗ |
| K203182 | SubtleMR | Subtle Medical, Inc. | 2021-02-26 | Traditional | PDF ↗ |
| K202990 | NinesMeasure | Nines, Inc. | 2021-02-25 | Traditional | PDF ↗ |
| K202212 | TruPlan | Circle Cardiovascular Imaging, Inc. | 2021-02-19 | Traditional | PDF ↗ |
| K200589 | MyPAO Planning Report | Medacta International S.A. | 2021-02-19 | Traditional | PDF ↗ |
| K210136 | PhantomMSK Hip | OrthoGrid Systems, Inc. | 2021-02-18 | Special | PDF ↗ |
| K203312 | Vitrea Software Package, VSTP-001A | Canon Medical Systems Corporation | 2021-02-16 | Traditional | PDF ↗ |
| K203103 | Synapse 3D, Synapse 3D Base Tools v6.1 | Fujifilm Corporation | 2021-02-09 | Traditional | PDF ↗ |
| K203290 | Bonelogic | Disior, Ltd. | 2021-02-05 | Traditional | PDF ↗ |
| K203582 | QUIBIM Precision Prostate (qp-Prostate) | Quibim S.L. | 2021-02-04 | Traditional | PDF ↗ |
| K203104 | IBM iConnect Access | Merge Healthcare Incorporated | 2021-01-26 | Traditional | PDF ↗ |
| K203677 | ViewPoint 6 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2021-01-15 | Special | PDF ↗ |
| K202847 | AccuBrain | Brainnow Medical Technology Limited | 2021-01-15 | Traditional | PDF ↗ |
| K203142 | Veuron-Brain-pAb | Heuron Co., Ltd. | 2021-01-15 | Traditional | PDF ↗ |
| K202414 | BrainInsight | Hyperfine Research, Inc. | 2021-01-07 | Traditional | PDF ↗ |
| K202229 | AI Metrics | Ai Metrics, LLC | 2020-12-22 | Traditional | PDF ↗ |
| K201250 | SQuEEZ Software | Cardiowise, Inc. | 2020-12-18 | Traditional | PDF ↗ |
Product code LLZ · Class II · Radiology. Data: openFDA.