System, Image Processing, Radiological
Regulation 892.2050
48510(k)s in 12 months (2,295 all time)
25recalls in 12 months (562 all time)
544recalls that name a 510(k)
Top companies in LLZ
| Company | 510(k)s | Recalls |
|---|---|---|
| Siemens AG Medical Solutions | 95 | 89 |
| GE Healthcare | 23 | 84 |
| Merge Healthcare Incorporated | 6 | 61 |
| Carestream Health, Inc. | 9 | 53 |
| Vital Images, Inc. | 34 | 10 |
| Agfa Corp. | 6 | 34 |
| Totoku Electric Co., Ltd. | 40 | 0 |
| Barco N.V. | 37 | 0 |
| Eizo Nanao Corporation | 34 | 0 |
| Ewoosoft Co., Ltd. | 29 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 17, 2017 | K170195 | QuantX Quantitative Insights, Inc. | LLZ |
| May 17, 2017 | K161601 | Dynamika Image Analysis Limited, GB | LLZ |
| May 11, 2017 | K170419 | SurgiCase Viewer Materialise NV, BE | LLZ |
| May 11, 2017 | K163622 | Lung Vision Bodyvision Medical , Ltd., IL | LLZ |
| May 11, 2017 | K163250 | Longitudinal Brain Imaging (LoBI) application Philips Medical Systems Nederland B.V., NL | LLZ |
| May 8, 2017 | K170180 | Will3D Hdx Will Corp., KR | LLZ |
| May 4, 2017 | K171130 | Nucleus Image Management System Nucleushealth, LLC | LLZ |
| May 1, 2017 | K163119 | NaviSuite SSI Edition Medcom GmbH, DE | LLZ |
| May 1, 2017 | K162647 | NuVasive NuvaLine Mobile App Nu Vasive, Incorporated | LLZ |
| Apr 28, 2017 | K170952 | syngo.CT View&GO Siemens Medical Solutions USA, Inc. | LLZ |
| Apr 26, 2017 | K170069 | AmCAD-UV Amcad Biomed Corporation, TW | LLZ |
| Apr 25, 2017 | K162799 | Cliniview Palodex Group OY, FI | LLZ |
| Apr 11, 2017 | K170580 | Carestream Vue PACS Carestream Health, Inc. | LLZ |
| Apr 6, 2017 | K162287 | Synapse 3D Perfusion Analysis Fujifilm Medical Systems U.S.A, Inc. | LLZ |
| Apr 5, 2017 | K163076 | Segment CMR Medviso AB, SE | LLZ |
| Apr 5, 2017 | K161341 | LIFESYS PACS Lifetrack Medical Systems, Inc., PH | LLZ |
| Mar 31, 2017 | K162559 | Move Forward 3D Motion Simulation Service Biomet, Inc. | LLZ |
| Mar 24, 2017 | K163290 | INFINITT ULite Infinitt Co., Ltd., KR | LLZ |
| Mar 21, 2017 | K163405 | 360KS Implant Positioning System Kico Knee Innovation Company Pty Limited, AU | LLZ |
| Mar 17, 2017 | K162868 | Exam Vue PACS Jpi Healthcare Solutions, Inc., KR | LLZ |
| Mar 16, 2017 | K170451 | FDX Console (DR-ID300CL) Software Fujifilm Medical Systems U.S.A, Inc. | LLZ |
| Mar 3, 2017 | K170167 | True 3D Viewer Software Echopixel, Inc. | LLZ |
| Feb 23, 2017 | K162484 | Lung Nodule Assessment and Comparison Option (LNA) Philips Medical Systems Nederland B.V., NL | LLZ |
| Feb 14, 2017 | K163285 | syngo Application Software Siemens Medical Solution USA, Inc. | LLZ |
| Feb 14, 2017 | K162830 | SIS Software Surgical Information Sciences, Inc. | LLZ |
| Feb 6, 2017 | K163294 | syngo.MR General, syngo.MR Cardiology, syngo.MR Neurology Siemens Medical Solutions USA, Inc. | LLZ |
| Feb 6, 2017 | K160934 | UC-CARE NaviGo Workstation UC-CARE , Ltd., IL | LLZ |
| Jan 31, 2017 | K163122 | NobelClinician, DTX Studio implant Nobel Biocare AB, SE | LLZ |
| Jan 27, 2017 | K163324 | nordicBrainEx Nordicneurolab AS, NO | LLZ |
| Jan 27, 2017 | K162285 | EBM iDO Viewer 1.2.1 Ebm Technologies Incorporated, TW | LLZ |
| Jan 26, 2017 | K163574 | Multi Modality Viewer Vital Images, Inc. | LLZ |
| Jan 12, 2017 | K163533 | EzDent-i; E2; ProraView Ewoosoft Co., Ltd., KR | LLZ |
| Jan 9, 2017 | K161841 | D2P 3D Systems, Inc., IL | LLZ |
| Jan 6, 2017 | K163013 | Quantib Brain 1.2 Quantib B.V., NL | LLZ |
| Jan 5, 2017 | K163253 | Arterys Cardio DL Arterys, Inc. | LLZ |
| Jan 4, 2017 | K161270 | CephSimulation Anatomage, Inc. | LLZ |
| Jan 3, 2017 | K163421 | syngo.via MI Workflows Siemens Medical Solutions USA, Inc. | LLZ |
| Dec 28, 2016 | K161959 | ClearView cCAD Clearview Diagnostics, Inc. | LLZ |
| Dec 23, 2016 | K163539 | Ez3D-i / E3 Ewoosoft Co., Ltd., KR | LLZ |
| Dec 19, 2016 | K162955 | Multi-Modality Tumor Tracking (MMTT) application Philips Medical Systems Nederland B.V., NL | LLZ |
| Dec 15, 2016 | K160852 | Zia Zetta Medical Technologies, LLC | LLZ |
| Dec 8, 2016 | K162376 | CAAS MR 4D Flow Pie Medical Imaging BV, NL | LLZ |
| Dec 7, 2016 | K161322 | CT CoPilot Zepmed, LLC | LLZ |
| Dec 5, 2016 | K152009 | DENSEEMAMMO v1.0 Statlife, FR | LLZ |
| Dec 2, 2016 | K163158 | MEDSYNAPSE Zero Footprint Viewer Medsynaptic Private, Ltd., IN | LLZ |
| Nov 22, 2016 | K162743 | ViewPoint 6 GE Medical Systems Ultrasound and Primary Care Diagnostics | LLZ |
| Nov 16, 2016 | K162541 | syngo Application Software Siemens Medical Solutions USA, Inc. | LLZ |
| Nov 15, 2016 | K161515 | eUnity Client Outlook, Inc., CA | LLZ |
| Nov 10, 2016 | K161634 | IPS CaseDesigner Nobel Biocare AB, SE | LLZ |
| Oct 28, 2016 | K162513 | Arterys Software v2.0 Arterys, Inc. | LLZ |
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