LLZ
2,283 FDA 510(k) clearances · Product code
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| Record | Firm | Date |
|---|---|---|
| Veuron-Brain-pAb2 (K213801) | Heuron Co., Ltd. | 2022-02-04 |
| Quantib ND (K213737) | Quantib B.V. | 2022-01-14 |
| UNiD Spine Analyzer (K212005) | Medicrea International, Inc. | 2022-01-12 |
| AIBOLIT 3D+ (K211443) | Aibolit Technologies, LLC | 2022-01-07 |
| VUZE System (K210830) | Vuze Medical , Ltd. | 2022-01-03 |
| CONVIVO In Vivo Pathology Suite (K211156) | Carl Zeiss Meditec, AG | 2021-12-29 |
| Claritas iPET (K213140) | Claritas Healthtech Pte, Ltd. | 2021-12-22 |
| Libby IAAA v1.0 (K210931) | Dyad Medical, Inc. | 2021-12-17 |
| Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking, Brainlab Elements Image Fusion, Brainlab Elements Image Fusion Angio (K212420) | Brainlab AG | 2021-12-16 |
| BIT-Motion (K211039) | Dde Mri Solutions, Ltd. | 2021-12-15 |
| Will3D (K211114) | Hdx Will Corp. | 2021-12-15 |
| EXA (K203743) | Konica Minolta Healthcare Americas, Inc. | 2021-12-10 |
| X-Clever (K212137) | Lg Electronics.Inc | 2021-12-10 |
| PVmed Contouring Software (K210916) | Perception Vision Medical Technologies Ltd.Co. | 2021-12-03 |
| ImplaStation (K210241) | Prodigident, Inc. | 2021-12-03 |
| Myomics Q (K211432) | Phantomics, Inc. | 2021-11-23 |
| MiPACS HTML5 Web Viewer (K212984) | Lead Technologies, Inc. | 2021-11-12 |
| MAMMOVISTA B.smart (K212621) | Siemens Medical Solutions USA, Inc. | 2021-11-12 |
| Intellijoint VIEW (K211876) | Intellijoint Surgical, Inc. | 2021-11-12 |
| inVisionOS (K210344) | Precisionos Technology, Inc. | 2021-11-10 |
| RTapp (K212887) | Segana, Inc. | 2021-11-10 |
| Hura CTP v1.0 (K212550) | Hura Imaging, Inc. | 2021-11-08 |
| GIQuant (K211356) | Motilent, Ltd. | 2021-11-08 |
| Visible Patient Suite (K212896) | Visible Patient, Sas | 2021-11-05 |
| VisionX 3.0 (K213326) | Durr Dental SE | 2021-11-02 |
| ATEC Alignment App (K211987) | Alphatec Spine, Inc. | 2021-10-29 |
| FlightPlan for Liver (K210807) | GE Medical Systems SCS | 2021-10-22 |
| iRAD (K212470) | Claritas Healthtech Pte, Ltd. | 2021-10-20 |
| Change Healthcare Cardiology (K212528) | Change Healthcare Israel , Ltd. | 2021-10-18 |
| SwiftMR (K210999) | Airs Medical, Inc. | 2021-10-14 |
| Brainance MD (K202808) | Advantis Medical Imaging Single Member P.C. | 2021-10-14 |
| NAVIPLAN - CT Planning Software for Total Hip Replacement (K211429) | Naviswiss AG | 2021-10-05 |
| EzDent-i/ E2/ Prora View/ Smart M Viewer (K211795) | Ewoosoft Co., Ltd. | 2021-10-04 |
| ImmersiveTouch (K210726) | Immersivetouch, Inc. | 2021-09-29 |
| EzDent Web (K211700) | Ewoosoft Co., Ltd. | 2021-09-28 |
| Collaboration Live (K212777) | Philips Ultrasound, Inc. | 2021-09-24 |
| JiveX (Model Number / Release: 5.3) (K212321) | Visus Health IT GmbH | 2021-09-23 |
| KONICAMINOLTA DI-X1 (K212685) | Konica Minolta, Inc. | 2021-09-13 |
| EFAI PACS Picture Archiving and Communication System (K211257) | Ever Fortune.Ai, Co., Ltd. | 2021-09-10 |
| Kinepict Medical Imaging Tool 4.0 (K202056) | Kinepict Health, Ltd. | 2021-09-10 |
| ADAS 3D (K212421) | Adas3D Medical S.L. | 2021-09-03 |
| RBknee (K203696) | Radiobotics Aps | 2021-08-27 |
| EzOrtho (K211793) | Ewoosoft Co., Ltd. | 2021-08-23 |
| Ez3D-i/E3 (K211791) | Ewoosoft Co., Ltd. | 2021-08-20 |
| ROSA Hip System (K210998) | Orthosoft D/B/A Zimmer Cas | 2021-08-17 |
| Brain Perfusion (BP) application (K201573) | Philips Medical Systems Nederland B.V. | 2021-08-17 |
| TruSPECT Radiological Image Processing Station (K212230) | Spectrum Dynamics Medical, Ltd. | 2021-08-16 |
| eVolve PACS (K211863) | Evolve Pacs, Inc. | 2021-08-12 |
| DynaCAD (K212175) | Invivo Corporation | 2021-08-02 |
| Volpara Imaging Software (K211279) | Volpara Health Technologies Limited | 2021-07-27 |
| ClariCT.AI (K212074) | Claripi, Inc. | 2021-07-27 |
| aPROMISE (K211655) | Exini Diagnostics AB | 2021-07-27 |
| MySpine WebPlanner & MyBalance (K211386) | Medacta International S.A. | 2021-07-23 |
| ZIRKONZAHN.Implant-Planner, ZIRKONZAHN.Implant-Planner Practice, CAD/CAM STL Converter, CAD/CAM Z-Tray (K203765) | Zirkonzahn Srl | 2021-07-20 |
| PRE-SURE (K201835) | Lazarus 3D, Inc. | 2021-07-08 |
| NubeX (K211480) | Techheim Co., Ltd. | 2021-07-08 |
| ONE Planner Hip (K210653) | Orthosoft D/B/A Zimmer Cas | 2021-07-07 |
| 3D Echo v1.1 (K211656) | Jointvue, LLC | 2021-06-25 |
| Qmenta Care Platform Family (K202718) | Mint Labs, Inc., D/B/A. Qmenta | 2021-06-16 |
| ZedView (K200704) | Lexi Co., Ltd. | 2021-05-27 |
| Universal Viewer (K211312) | GE Healthcare | 2021-05-21 |
| Xoran Workstation, Model 10050 (K210257) | Xoran Technologies, LLC | 2021-05-20 |
| Overjet Dental Assist (K210187) | Overjet, Inc. | 2021-05-19 |
| Cercare Medical Neurosuite (K202793) | Cercare Medical Aps | 2021-05-17 |
| HOLOSCOPE-i (K210072) | Real View Imaging , Ltd. | 2021-05-14 |
| ImagePilot (K210066) | Konica Minolta, Inc. | 2021-05-06 |
| SOTA Cloud Imaging (K210682) | Sota Precision Optics, Inc. Dba Sota Imaging | 2021-05-04 |
| PtoleMedic System (K202521) | Lento Medical Innovation, Inc. | 2021-05-04 |
| DeepLook PRECISE (K202084) | Deeplook, Inc. | 2021-04-09 |
| ADAS 3D (K210850) | Adas3D Medical S.L. | 2021-04-05 |
| Simpleware ScanIP Medical (K203195) | Synopsys (Northern Europe) , Ltd. | 2021-04-01 |
| SIS System (Version 5.1.0) (K210071) | Surgical Information Sciences, Inc. | 2021-03-31 |
| Quicktome (K203518) | Omniscient Neurotechnology Pty Ltd (O8t) | 2021-03-09 |
| Cuptimize (K203651) | Cuptimize, Inc. | 2021-02-26 |
| SubtleMR (K203182) | Subtle Medical, Inc. | 2021-02-26 |
| NinesMeasure (K202990) | Nines, Inc. | 2021-02-25 |
| MyPAO Planning Report (K200589) | Medacta International S.A. | 2021-02-19 |
| TruPlan (K202212) | Circle Cardiovascular Imaging, Inc. | 2021-02-19 |
| PhantomMSK Hip (K210136) | OrthoGrid Systems, Inc. | 2021-02-18 |
| Vitrea Software Package, VSTP-001A (K203312) | Canon Medical Systems Corporation | 2021-02-16 |
| Synapse 3D, Synapse 3D Base Tools v6.1 (K203103) | Fujifilm Corporation | 2021-02-09 |
| Bonelogic (K203290) | Disior, Ltd. | 2021-02-05 |
| QUIBIM Precision Prostate (qp-Prostate) (K203582) | Quibim S.L. | 2021-02-04 |
| IBM iConnect Access (K203104) | Merge Healthcare Incorporated | 2021-01-26 |
| ViewPoint 6 (K203677) | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2021-01-15 |
| AccuBrain (K202847) | Brainnow Medical Technology Limited | 2021-01-15 |
| Veuron-Brain-pAb (K203142) | Heuron Co., Ltd. | 2021-01-15 |
| BrainInsight (K202414) | Hyperfine Research, Inc. | 2021-01-07 |
| AI Metrics (K202229) | Ai Metrics, LLC | 2020-12-22 |
| SQuEEZ Software (K201250) | Cardiowise, Inc. | 2020-12-18 |
| Nucleus.io (K203249) | Nucleushealth, LLC | 2020-12-04 |
| HealthJOINT (K202487) | Zebra Medical Vision, Ltd. | 2020-12-04 |
| Planmeca Romexis (K200572) | Planmeca Oy | 2020-12-02 |
| Optimized Positioning System (OPS) Insight (K202805) | Corin USA | 2020-11-20 |
| CorInsights MRI (K193287) | Adm Diagnostics, Inc. | 2020-11-20 |
| DTX Studio Clinic (K203156) | Nobel Biocare AB | 2020-11-20 |
| DBSWIN, VISTAEASY (K203287) | Dürr Dental SE | 2020-11-18 |
| PROView (K193306) | GE Medical Systems SCS | 2020-11-17 |
| Neuro.Al Algorithm (K200750) | Terarecon,Inc. | 2020-11-06 |
| MyHip Planner & Verifier (K200350) | Medacta International S.A. | 2020-11-04 |
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