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 8 of 23
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K163250 | Longitudinal Brain Imaging (LoBI) application | Philips Medical Systems Nederland B.V. | 2017-05-11 | Traditional | PDF ↗ |
| K163622 | Lung Vision | Bodyvision Medical , Ltd. | 2017-05-11 | Traditional | PDF ↗ |
| K170419 | SurgiCase Viewer | Materialise NV | 2017-05-11 | Traditional | PDF ↗ |
| K170180 | Will3D | Hdx Will Corp. | 2017-05-08 | Traditional | PDF ↗ |
| K171130 | Nucleus Image Management System | Nucleushealth, LLC | 2017-05-04 | Traditional | PDF ↗ |
| K162647 | NuVasive NuvaLine Mobile App | Nu Vasive, Incorporated | 2017-05-01 | Traditional | PDF ↗ |
| K163119 | NaviSuite SSI Edition | Medcom GmbH | 2017-05-01 | Traditional | PDF ↗ |
| K170952 | syngo.CT View&GO | Siemens Medical Solutions USA, Inc. | 2017-04-28 | Traditional | PDF ↗ |
| K170069 | AmCAD-UV | Amcad Biomed Corporation | 2017-04-26 | Traditional | PDF ↗ |
| K162799 | Cliniview | Palodex Group OY | 2017-04-25 | Traditional | PDF ↗ |
| K170580 | Carestream Vue PACS | Carestream Health, Inc. | 2017-04-11 | Traditional | PDF ↗ |
| K162287 | Synapse 3D Perfusion Analysis | Fujifilm Medical Systems U.S.A, Inc. | 2017-04-06 | Traditional | PDF ↗ |
| K161341 | LIFESYS PACS | Lifetrack Medical Systems, Inc. | 2017-04-05 | Traditional | PDF ↗ |
| K163076 | Segment CMR | Medviso AB | 2017-04-05 | Traditional | PDF ↗ |
| K162559 | Move Forward 3D Motion Simulation Service | Biomet, Inc. | 2017-03-31 | Traditional | PDF ↗ |
| K163290 | INFINITT ULite | Infinitt Co., Ltd. | 2017-03-24 | Special | PDF ↗ |
| K163405 | 360KS Implant Positioning System | Kico Knee Innovation Company Pty Limited | 2017-03-21 | Traditional | PDF ↗ |
| K162868 | Exam Vue PACS | Jpi Healthcare Solutions, Inc. | 2017-03-17 | Traditional | PDF ↗ |
| K170451 | FDX Console (DR-ID300CL) Software | Fujifilm Medical Systems U.S.A, Inc. | 2017-03-16 | Traditional | PDF ↗ |
| K170167 | True 3D Viewer Software | Echopixel, Inc. | 2017-03-03 | Special | PDF ↗ |
| K162484 | Lung Nodule Assessment and Comparison Option (LNA) | Philips Medical Systems Nederland B.V. | 2017-02-23 | Traditional | PDF ↗ |
| K162830 | SIS Software | Surgical Information Sciences, Inc. | 2017-02-14 | Traditional | PDF ↗ |
| K163285 | syngo Application Software | Siemens Medical Solution USA, Inc. | 2017-02-14 | Traditional | PDF ↗ |
| K163294 | syngo.MR General, syngo.MR Cardiology, syngo.MR Neurology | Siemens Medical Solutions USA, Inc. | 2017-02-06 | Traditional | PDF ↗ |
| K160934 | UC-CARE NaviGo Workstation | UC-CARE , Ltd. | 2017-02-06 | Traditional | PDF ↗ |
| K163122 | NobelClinician, DTX Studio implant | Nobel Biocare AB | 2017-01-31 | Traditional | PDF ↗ |
| K162285 | EBM iDO Viewer 1.2.1 | Ebm Technologies Incorporated | 2017-01-27 | Traditional | PDF ↗ |
| K163324 | nordicBrainEx | Nordicneurolab AS | 2017-01-27 | Traditional | PDF ↗ |
| K163574 | Multi Modality Viewer | Vital Images, Inc. | 2017-01-26 | Traditional | PDF ↗ |
| K163533 | EzDent-i; E2; ProraView | Ewoosoft Co., Ltd. | 2017-01-12 | Special | PDF ↗ |
| K161841 | D2P | 3D Systems, Inc. | 2017-01-09 | Traditional | PDF ↗ |
| K163013 | Quantib Brain 1.2 | Quantib B.V. | 2017-01-06 | Special | PDF ↗ |
| K163253 | Arterys Cardio DL | Arterys, Inc. | 2017-01-05 | Traditional | PDF ↗ |
| K161270 | CephSimulation | Anatomage, Inc. | 2017-01-04 | Traditional | PDF ↗ |
| K163421 | syngo.via MI Workflows | Siemens Medical Solutions USA, Inc. | 2017-01-03 | Special | PDF ↗ |
| K161959 | ClearView cCAD | Clearview Diagnostics, Inc. | 2016-12-28 | Traditional | PDF ↗ |
| K163539 | Ez3D-i / E3 | Ewoosoft Co., Ltd. | 2016-12-23 | Special | PDF ↗ |
| K162955 | Multi-Modality Tumor Tracking (MMTT) application | Philips Medical Systems Nederland B.V. | 2016-12-19 | Traditional | PDF ↗ |
| K160852 | Zia | Zetta Medical Technologies, LLC | 2016-12-15 | Traditional | PDF ↗ |
| K162376 | CAAS MR 4D Flow | Pie Medical Imaging BV | 2016-12-08 | Traditional | PDF ↗ |
| K161322 | CT CoPilot | Zepmed, LLC | 2016-12-07 | Traditional | PDF ↗ |
| K152009 | DENSEEMAMMO v1.0 | Statlife | 2016-12-05 | Traditional | PDF ↗ |
| K163158 | MEDSYNAPSE Zero Footprint Viewer | Medsynaptic Private, Ltd. | 2016-12-02 | Traditional | PDF ↗ |
| K162743 | ViewPoint 6 | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2016-11-22 | Traditional | PDF ↗ |
| K162541 | syngo Application Software | Siemens Medical Solutions USA, Inc. | 2016-11-16 | Traditional | PDF ↗ |
| K161515 | eUnity | Client Outlook, Inc. | 2016-11-15 | Special | PDF ↗ |
| K161634 | IPS CaseDesigner | Nobel Biocare AB | 2016-11-10 | Traditional | PDF ↗ |
| K162513 | Arterys Software v2.0 | Arterys, Inc. | 2016-10-28 | Traditional | PDF ↗ |
| K162145 | vRad PACS with Mammography | Virtual Radiologic Corporation | 2016-10-25 | Abbreviated | PDF ↗ |
| K162474 | Artemis | Eigen | 2016-10-21 | Traditional | PDF ↗ |
| K162025 | IntelliSpace Portal Platform | Philips Medical Systems Nederlands B.V. | 2016-10-18 | Traditional | PDF ↗ |
| K162011 | MedDream | Softneta Uab | 2016-10-14 | Traditional | PDF ↗ |
| K160371 | NovaPACS | Novarad Corporation | 2016-10-14 | Traditional | PDF ↗ |
| K161109 | iSR'obot MRI-US Fusion | Biobot Surgical Pte., Ltd. | 2016-10-06 | Traditional | PDF ↗ |
| K160666 | Dentiq3D | 3D Industrial Imaging Co., Ltd. | 2016-10-05 | Traditional | PDF ↗ |
| K161828 | kneeEOS | Onefit Medical | 2016-10-03 | Traditional | PDF ↗ |
| K162112 | CAAS MRV | Pie Medical Imaging BV | 2016-09-21 | Traditional | PDF ↗ |
| K162339 | Scenium | Siemens Medical Solutions USA, Inc. | 2016-09-21 | Special | PDF ↗ |
| K161625 | PixelShine | Algomedica | 2016-09-19 | Traditional | PDF ↗ |
| K162008 | JiveX | Visus Technology Transfer GmbH | 2016-09-16 | Traditional | PDF ↗ |
| K162141 | Restore PACS | Xian Wingspan Electronic Technology Co., Ltd. | 2016-09-02 | Traditional | PDF ↗ |
| K153705 | PROcedure Rehearsal Studio | 3Dsystems, Simbionix Products | 2016-09-02 | Special | PDF ↗ |
| K161130 | ResolutionMD | Calgary Scientific, Inc. | 2016-08-24 | Traditional | PDF ↗ |
| K152949 | WebPAX | Heart Imaging Technologies, LLC | 2016-08-17 | Traditional | PDF ↗ |
| K161518 | PACS CORE/ENCORE | Compania Mexicana DE Radiologia Cgr, S.A. DE C.V. | 2016-08-17 | Traditional | PDF ↗ |
| K161955 | 5D Viewer | Samsung Medison Co., Ltd. | 2016-08-10 | Traditional | PDF ↗ |
| K161148 | icobrain | Icometrix | 2016-08-09 | Traditional | PDF ↗ |
| K161113 | QXLink | Vieworks Co., Ltd. | 2016-08-05 | Special | PDF ↗ |
| K160284 | JointPoint | Jointpoint, Inc. | 2016-08-03 | Traditional | PDF ↗ |
| K160937 | Senolris | GE Healthcare | 2016-08-01 | Traditional | PDF ↗ |
| K161118 | SIMPLANT Online Case Review and SIMPLANT Editor | Dentsply Sirona | 2016-07-28 | Traditional | PDF ↗ |
| K161382 | LVivo Software Application | Diacardio, Ltd. | 2016-07-28 | Traditional | PDF ↗ |
| K161419 | Multi Modality Viewer | Vital Images, Inc. | 2016-07-13 | Traditional | PDF ↗ |
| K161685 | syngo®.via protoNeo (Version VA10A) | Siemens Healthcare GmbH | 2016-07-11 | Traditional | PDF ↗ |
| K161479 | hipEOS | Onefit Medical | 2016-06-28 | Special | PDF ↗ |
| K160584 | Surgical Navigation Advanced Platform (SNAP) | Surgical Theater, LLC | 2016-06-28 | Traditional | PDF ↗ |
| K161559 | Kuvia3D | 4qimaging, LLC Dba Qmetrics | 2016-06-23 | Traditional | PDF ↗ |
| K161061 | IMPAX Volume Viewing 4.0 | Agfa Healthcare N.V. | 2016-06-22 | Traditional | PDF ↗ |
| K160334 | Advanced Medical Imaging Software Suite (KSWVWR) | Keosys Sas | 2016-06-21 | Traditional | PDF ↗ |
| K161444 | DBSWIN and VistaEasy Imaging Software | Duerr Dental AG | 2016-06-21 | Special | PDF ↗ |
| K153351 | Quantib Brain 1 | Quantib B.V. | 2016-06-17 | Traditional | PDF ↗ |
| K161188 | HEPATIQ 1.1 | Hepatiq, LLC | 2016-06-09 | Special | PDF ↗ |
| K161246 | Ez3D-i / E3 | Ewoosoft Co., Ltd. | 2016-05-31 | Special | PDF ↗ |
| K153736 | 3mensio Workstation | Pie Medical Imaging BV | 2016-05-27 | Traditional | PDF ↗ |
| K161117 | EzDent-i / E2 / Prora View | Ewoosoft Co., Ltd. | 2016-05-13 | Special | PDF ↗ |
| K151913 | MIM-Thin Client (mobile) | Mim Software, Inc. | 2016-04-25 | Traditional | PDF ↗ |
| K160914 | sterEOS Workstation | Eos Imaging, Inc. | 2016-04-22 | Special | PDF ↗ |
| K153653 | DICOM Viewer | Brainlab AG | 2016-04-13 | Traditional | PDF ↗ |
| K160376 | EndoSize | Therenva Sas | 2016-04-12 | Special | PDF ↗ |
| K160407 | spineEOS | Onefit Medical | 2016-04-08 | Traditional | PDF ↗ |
| K160579 | Xmaru View V1 and Xmaru PACS, Medical Image Processing Software | Rayence Co., Ltd. | 2016-04-08 | Special | PDF ↗ |
| K153284 | Synaptive ImageDrive Pro | Synaptive Medical, Inc. | 2016-03-29 | Traditional | PDF ↗ |
| K152716 | EV Insite System | Psp Corporation | 2016-03-24 | Traditional | PDF ↗ |
| K160150 | Vitrea CT Colon Analysis | Vital Images, Inc. | 2016-03-16 | Traditional | PDF ↗ |
| K153355 | Xeleris 4.0 Processing and Review Workstation | GE Healthcare | 2016-03-16 | Traditional | PDF ↗ |
| K153612 | ArthrexVIP Web Portal | Custom Orthopaedic Solutions, Inc. | 2016-03-15 | Traditional | PDF ↗ |
| K160426 | syngo.via MI Workflows | Siemens Medical Solutions USA, Inc. | 2016-03-04 | Special | PDF ↗ |
| K153346 | syngo Application Software VD11 | Siemens Medical Solutions USA, Inc. | 2016-03-04 | Traditional | PDF ↗ |
| K152602 | Olea Sphere V3.0 | Olea Medical | 2016-03-03 | Traditional | PDF ↗ |
| K160317 | syngo.via MI Workflows | Siemens Medical Solutions USA, Inc. | 2016-02-29 | Special | PDF ↗ |
Product code LLZ · Class II · Radiology. Data: openFDA.