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 |
|---|---|---|---|
| Mar 3, 2016 | K152602 | Olea Sphere V3.0 Olea Medical, FR | LLZ |
| Feb 29, 2016 | K160317 | syngo.via MI Workflows Siemens Medical Solutions USA, Inc. | LLZ |
| Feb 25, 2016 | K153091 | IMPLANT 3D Media Lab S.R.L., IT | LLZ |
| Feb 25, 2016 | K151737 | MedicVOD System Orpheus Medical , Ltd., IL | LLZ |
| Feb 23, 2016 | K152034 | FS-PACS Ec-Web Co., Ltd., TW | LLZ |
| Feb 19, 2016 | K160315 | I4 (Integrated Intelligent Imaging Informatics) system Philips Medical Systems Nederland B.V., NL | LLZ |
| Feb 18, 2016 | K143290 | DBSWIN and VistaEasy Imaging Software Durr Dental AG, DE | LLZ |
| Feb 17, 2016 | K153593 | CliniscanSM MRI Picofemto, LLC | LLZ |
| Feb 12, 2016 | K160001 | TraumaCad Mobile Release 2.0 Voyant Health, Ltd., IL | LLZ |
| Feb 12, 2016 | K153103 | CARESTREAM Vue PACS Carestream Health, Inc. | LLZ |
| Feb 3, 2016 | K160108 | Synapse PACS Fujifilm Medical Systems U.S.A, Inc. | LLZ |
| Jan 25, 2016 | K153166 | Fusion Bx Focal Healtcare, Inc., CA | LLZ |
| Jan 25, 2016 | K152977 | DG PACS Dicom Grid, Inc. | LLZ |
| Jan 20, 2016 | K152352 | Stereo 3D option for Vision Applications GE Medical Systems SCS, FR | LLZ |
| Jan 15, 2016 | K153289 | HEALTHMYNE Healthmyne, Inc. | LLZ |
| Jan 15, 2016 | K151075 | BR-ABVS Viewer 1.0 Taihao Medical, Inc., TW | LLZ |
| Jan 12, 2016 | K151152 | ImplantMax Software Saturn Imaging, Inc., TW | LLZ |
| Jan 7, 2016 | K153427 | Volpara Imaging Software Matakina Technology, Ltd., NZ | LLZ |
| Jan 3, 2016 | K152746 | Ez3D Plus Ewoosoft Co., Ltd., KR | LLZ |
| Dec 14, 2015 | K152172 | Econsole1 DRTECH Corporation, KR | LLZ |
| Dec 4, 2015 | K152078 | Implant Studio 2015 3Shape Medical A/S, DK | LLZ |
| Nov 25, 2015 | K152822 | VidiStar HeartView Vidistar, LLC | LLZ |
| Nov 18, 2015 | K153022 | Philips IntelliSpace Cardiovascular Philips Medical Systems Nethrlands BV, NL | LLZ |
| Nov 16, 2015 | K153073 | UroNav (Version 2.0) Invivo Corporation | LLZ |
| Nov 16, 2015 | K152661 | HICAT Air Hicat GmbH, DE | LLZ |
| Nov 4, 2015 | K151212 | Ziostation2 Qi Imaging, LLC | LLZ |
| Oct 26, 2015 | K152028 | Volpara Imaging Software Matakina Technologies Limited, NZ | LLZ |
| Oct 15, 2015 | K151988 | Visible Patient Suite Visible Patient, Sas, FR | LLZ |
| Oct 7, 2015 | K151941 | DEXIS Webview Imaging Sciences International /Gendex/Dexis | LLZ |
| Oct 2, 2015 | K151501 | OrthoVis Web Portal Custom Orthopaedic Solutions, Inc. | LLZ |
| Sep 21, 2015 | K151774 | CARESTREAM Vue Motion Carestream Health, Inc. | LLZ |
| Sep 2, 2015 | K143586 | FACT Medical Imaging Sysytem Dexin Medical Imaging Technology Co., Ltd., CN | LLZ |
| Sep 1, 2015 | K151957 | BOX DICOM Viewer Box, Inc. | LLZ |
| Aug 20, 2015 | K152186 | HealthMyne PACS Healthmyne, Inc. | LLZ |
| Aug 19, 2015 | K151837 | CS 3D Imaging Trophy, FR | LLZ |
| Aug 19, 2015 | K151371 | Corporate Dental Imaging (CDI) Application U.S. Army Dental Command (Dencom) | LLZ |
| Aug 12, 2015 | K151859 | Synapse Cardiovascular Fujifilm Medical Systems U.S.A, Inc. | LLZ |
| Aug 11, 2015 | K151850 | McKesson Cardiology Mckesson Israel , Ltd., IL | LLZ |
| Aug 7, 2015 | K151353 | syngo.MR Neurology, syngo.MR Oncology Siemens Medical Solutions USA, Inc. | LLZ |
| Aug 3, 2015 | K151687 | QuantorView 3Disc Americas | LLZ |
| Jul 31, 2015 | K151568 | Arthrex OrthoVis Preoperative Plan Custom Orthopaedic Solutions, Inc. | LLZ |
| Jul 29, 2015 | K151808 | 3D/5D Viewer Samsung Medison Co., Ltd., KR | LLZ |
| Jul 29, 2015 | K143368 | GenIQ Ge Medical Systems, LLC | LLZ |
| Jul 28, 2015 | K151854 | 3MP (X213C3P0E, X213G3P0E) and 2MP (X213C2P0E, X213G2P0E) LCD Display D-View Display Technology Co., Ltd., CN | LLZ |
| Jul 17, 2015 | K143176 | UltraLinq Ultralinq Healthcare Solutions, Inc. | LLZ |
| Jul 13, 2015 | K151091 | Vitrea Software Toshiba Package, VSTP-001A Toshibamedical Systems Corporation, JP | LLZ |
| Jul 9, 2015 | K150313 | Ablation Confirmation Neuwave Medical, Inc. | LLZ |
| Jul 7, 2015 | K151438 | Dentrix Ascend Imaging Realcloud Imaging, Inc. | LLZ |
| Jun 26, 2015 | K142750 | JiveX Visus Technology Transfer GmbH, DE | LLZ |
| Jun 23, 2015 | K151192 | syngo.via MI Workflows Siemens Medical Solutions USA, Inc. | LLZ |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.