LLZ
2,283 FDA 510(k) clearances · Product code
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| Record | Firm | Date |
|---|---|---|
| McKesson Cardiology (K181080) | Change Healthcare Israel , Ltd. | 2018-05-24 |
| 5D Viewer (K180883) | Samsung Medison Co., Ltd. | 2018-05-15 |
| Invenia ABUS Viewer (K180641) | GE Healthcare | 2018-05-04 |
| hipEOS (K173390) | Onefit Medical | 2018-04-27 |
| syngo.plaza (K180563) | Siemens Healthcare GmbH | 2018-04-25 |
| ZOOM (K172768) | Zetta Medical Technologies, LLC | 2018-04-24 |
| Viz CTP (K180161) | Viz. Ai, Inc. | 2018-04-20 |
| syngo.MR Applications (K180336) | Siemens Medical Solutions USA, Inc. | 2018-04-19 |
| iSchemaView RAPID (K172477) | Ischemaview, Inc. | 2018-04-19 |
| ZED Link (K180549) | Zed Technologies | 2018-04-12 |
| Corin Optimized Positioning System (OPS™) Plan (K171847) | Corin U.S.A. Limited | 2018-04-05 |
| syngo.via MI Workflows (K173897) | Siemens Medical Solutions USA, Inc. | 2018-04-05 |
| PowerLook Density Assessment Software (K180125) | Icad, Inc. | 2018-04-05 |
| uWS-MI (K172998) | Shanghai United Imaging Healthcare Co., Ltd. | 2018-04-05 |
| SIMPLANT 18 (K172239) | Dentsply Sirona | 2018-04-04 |
| Scenium VE20 Software (K173597) | Siemens Medical Solutions USA, Inc. | 2018-04-04 |
| Vitrea Software Package; VSTP-001A (K180323) | Canon Medical Systems Corporation | 2018-03-30 |
| MED-TAB (K173241) | Plum Medical Solutions GmbH | 2018-03-23 |
| Mimics inPrint (K173619) | Materialise NV | 2018-03-21 |
| WillCeph (K172168) | Hdx Will Corp. | 2018-03-21 |
| Emprint Ablation Visualization Application (K180192) | Covidien, LLC | 2018-03-21 |
| Imbio Segmentation Editing Tool software (K180129) | Imbio, LLC | 2018-03-16 |
| syngo Application Software (K173611) | Siemens Medical Solutions USA, Inc. | 2018-03-16 |
| SICAT Endo (K180262) | Sicat GmbH & Co. KG | 2018-03-12 |
| BrightMatter Plan 1.6.0 (K180394) | Synaptive Medical, Inc. | 2018-03-09 |
| Quantib Brain (K173939) | Quantib B.V. | 2018-03-09 |
| icobrain (K180326) | Icometrix | 2018-03-08 |
| iQMR (K173605) | Medic Vision - Imaging Solutions, Ltd. | 2018-03-08 |
| ProBx Software (K173312) | Harmonus, Inc. | 2018-03-02 |
| CereMetrix Silver (K173145) | Ceremetrix Corp | 2018-02-28 |
| DM-Density (K170540) | Densitas, Inc. | 2018-02-23 |
| Ez3D-i /E3 (K173863) | Ewoosoft Co., Ltd. | 2018-02-23 |
| Velocity (K173636) | Varian Medical Systems, Inc. | 2018-02-15 |
| SuRgical Planner (SRP) (K170793) | Surgical Theater, LLC | 2018-02-12 |
| SENYINT Remote Consultation System (K162727) | Dalian Senyint Digital Medical System Co., Ltd. | 2018-02-08 |
| UNiD Spine Analyzer (K180091) | Medicrea International | 2018-02-08 |
| eUnity (K172490) | Client Outlook, Inc. | 2018-02-06 |
| Insight BD (K172832) | Siemens Medi Cal Solutions, Inc. | 2018-02-06 |
| MFI-Cardiac (K173512) | Multifunctional Imaging, LLC | 2018-02-05 |
| Vitrea Software Toshiba Package VSTP-001A (K173088) | Toshibamedical Systems Corporation | 2018-01-31 |
| Arterys Oncology DL (K173542) | Arterys, Inc. | 2018-01-25 |
| Navigo Workstation Version 2.0 (K173054) | UC-CARE , Ltd. | 2018-01-16 |
| CS Imaging (K173622) | Trophy | 2018-01-16 |
| Illumeo System (K173588) | Philips Medical Systems Technologies , Ltd. | 2018-01-12 |
| DTX Studio diagnose (K172224) | Nobel Biocare AB | 2018-01-11 |
| cNeuro cMRI (K171328) | Combinostics OY | 2018-01-08 |
| ViewPoint 6 (K173456) | Ge Medical Systems Ultrasound and Primary | 2018-01-05 |
| Radiomics App v1.0 (K173420) | Microsoft Corp. | 2017-12-27 |
| Advanced Diffusion Analysis (ADA) application (K173467) | Philips Medical Systems Nederland B.V. | 2017-12-12 |
| Merge PACS (K173475) | Merge Healthcare Incorporated | 2017-12-08 |
| MIM – Y90 Dosimetry (K172218) | Mim Software, Inc. | 2017-11-21 |
| syngo®.via protoNeo (Version VA20) (K173378) | Siemens Healthcare GmbH | 2017-11-20 |
| jFit Surgical Planner (K173329) | Jointvue, LLC | 2017-11-15 |
| Planmeca Romexis (K171385) | Planmeca Oy | 2017-11-14 |
| Surgical Planning Software version 1.1 (K173247) | Ortho Kinematics, Inc. | 2017-11-08 |
| Infinitt PACS 7.0 (K172803) | Infinitt Healthcare Co., Ltd. | 2017-10-27 |
| OrthoVision (K173094) | Ewoosoft Co., Ltd. | 2017-10-26 |
| BR-FHUS Viewer 1.0 (K171709) | Taihao Medical, Inc. | 2017-10-20 |
| Quantra (K163623) | Hologic, Inc. | 2017-10-20 |
| OrthoView 7.2 (K171068) | Meridian Technique, Ltd. | 2017-10-18 |
| Curve Image 2.0 PACS (K173101) | Curve Dental, Ltd. | 2017-10-18 |
| Vitrea Advanced Visualization, Version 7.6 (K172855) | Vital Images, Inc. | 2017-10-05 |
| ASPIRE Bellus II (K171463) | Fujifilm Medical Systems U.S.A, Inc. | 2017-09-29 |
| Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature Correction, Elements TRAM (K170816) | Brainlab AG | 2017-09-26 |
| 3D Echo (K172513) | Jointvue, LLC | 2017-09-14 |
| NeuroQuant (K170981) | Cortechs Labs, Inc. | 2017-09-07 |
| VMA™ System version 3.0 (K172327) | Ortho Kinematics, Inc. | 2017-08-25 |
| OKI Surgical Planning Software (K171617) | Ortho Kinematics, Inc. | 2017-08-22 |
| EzDent-i / E2 / Prora View (K172364) | Ewoosoft Co., Ltd. | 2017-08-22 |
| Clarity Reveal (K171356) | Ceevra, Inc. | 2017-08-03 |
| NovaPACS (K171754) | Novarad Corporation | 2017-07-28 |
| Smart Stitching Software System, Image Processing, Radiological (K163048) | Osko, Inc. | 2017-07-28 |
| BiopSee, Mobile US (K170841) | Medcom GmbH | 2017-07-26 |
| Vitrea View (K163232) | Vital Images, Inc. | 2017-07-21 |
| Examion X-AQS (K170729) | Examion GmbH | 2017-07-18 |
| Arterys Viewer (K171544) | Arterys, Inc. | 2017-07-18 |
| 3D Endo Software (K171115) | Dentsply Sirona | 2017-07-17 |
| Enterprise Imaging XERO Viewer 8.1 (K170434) | Agfa Healthcare N.V. | 2017-07-03 |
| SUITESTENSA (K163668) | Ebit Srl | 2017-06-23 |
| EchoPAC Software Only, EchoPAC Plug-in (K170847) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2017-06-14 |
| syngo Application Software (K170747) | Siemens Medical Solutions USA, Inc. | 2017-06-09 |
| Vitrea Software Toshiba Package; VSTP-001A (K171222) | Toshibamedical Systems Corporation | 2017-06-08 |
| SmartTarget (K170250) | Smarttarget, Ltd. | 2017-06-07 |
| syngo Dynamics Version VA30 (K171053) | Siemens Healthcare GmbH | 2017-06-01 |
| QLAB Advanced Quantification Software (K171314) | Philips Health Care | 2017-05-30 |
| AmCAD-US (K162574) | Amcad Biomed Corporation | 2017-05-30 |
| UNiD Spine Analyzer (K170172) | Medicrea International | 2017-05-24 |
| vascuCAP (K163071) | Elucid Bioimaging, Inc. | 2017-05-24 |
| QuantX (K170195) | Quantitative Insights, Inc. | 2017-05-17 |
| Dynamika (K161601) | Image Analysis Limited | 2017-05-17 |
| SurgiCase Viewer (K170419) | Materialise NV | 2017-05-11 |
| Lung Vision (K163622) | Bodyvision Medical , Ltd. | 2017-05-11 |
| Longitudinal Brain Imaging (LoBI) application (K163250) | Philips Medical Systems Nederland B.V. | 2017-05-11 |
| Will3D (K170180) | Hdx Will Corp. | 2017-05-08 |
| Nucleus Image Management System (K171130) | Nucleushealth, LLC | 2017-05-04 |
| NuVasive NuvaLine Mobile App (K162647) | Nu Vasive, Incorporated | 2017-05-01 |
| NaviSuite SSI Edition (K163119) | Medcom GmbH | 2017-05-01 |
| syngo.CT View&GO (K170952) | Siemens Medical Solutions USA, Inc. | 2017-04-28 |
| AmCAD-UV (K170069) | Amcad Biomed Corporation | 2017-04-26 |
| Cliniview (K162799) | Palodex Group OY | 2017-04-25 |
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