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 9 of 23
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K153091 | IMPLANT 3D | Media Lab S.R.L. | 2016-02-25 | Traditional | PDF ↗ |
| K151737 | MedicVOD System | Orpheus Medical , Ltd. | 2016-02-25 | Traditional | PDF ↗ |
| K152034 | FS-PACS | Ec-Web Co., Ltd. | 2016-02-23 | Traditional | PDF ↗ |
| K160315 | I4 (Integrated Intelligent Imaging Informatics) system | Philips Medical Systems Nederland B.V. | 2016-02-19 | Traditional | PDF ↗ |
| K143290 | DBSWIN and VistaEasy Imaging Software | Durr Dental AG | 2016-02-18 | Traditional | PDF ↗ |
| K153593 | CliniscanSM MRI | Picofemto, LLC | 2016-02-17 | Traditional | PDF ↗ |
| K153103 | CARESTREAM Vue PACS | Carestream Health, Inc. | 2016-02-12 | Traditional | PDF ↗ |
| K160001 | TraumaCad Mobile Release 2.0 | Voyant Health, Ltd. | 2016-02-12 | Special | PDF ↗ |
| K160108 | Synapse PACS | Fujifilm Medical Systems U.S.A, Inc. | 2016-02-03 | Traditional | PDF ↗ |
| K152977 | DG PACS | Dicom Grid, Inc. | 2016-01-25 | Traditional | PDF ↗ |
| K153166 | Fusion Bx | Focal Healtcare, Inc. | 2016-01-25 | Traditional | PDF ↗ |
| K152352 | Stereo 3D option for Vision Applications | GE Medical Systems SCS | 2016-01-20 | Traditional | PDF ↗ |
| K153289 | HEALTHMYNE | Healthmyne, Inc. | 2016-01-15 | Traditional | PDF ↗ |
| K151075 | BR-ABVS Viewer 1.0 | Taihao Medical, Inc. | 2016-01-15 | Traditional | PDF ↗ |
| K151152 | ImplantMax Software | Saturn Imaging, Inc. | 2016-01-12 | Traditional | PDF ↗ |
| K153427 | Volpara Imaging Software | Matakina Technology, Ltd. | 2016-01-07 | Traditional | PDF ↗ |
| K152746 | Ez3D Plus | Ewoosoft Co., Ltd. | 2016-01-03 | Traditional | PDF ↗ |
| K152172 | Econsole1 | DRTECH Corporation | 2015-12-14 | Traditional | PDF ↗ |
| K152078 | Implant Studio 2015 | 3Shape Medical A/S | 2015-12-04 | Traditional | PDF ↗ |
| K152822 | VidiStar HeartView | Vidistar, LLC | 2015-11-25 | Traditional | PDF ↗ |
| K153022 | Philips IntelliSpace Cardiovascular | Philips Medical Systems Nethrlands BV | 2015-11-18 | Traditional | PDF ↗ |
| K152661 | HICAT Air | Hicat GmbH | 2015-11-16 | Traditional | PDF ↗ |
| K153073 | UroNav (Version 2.0) | Invivo Corporation | 2015-11-16 | Traditional | PDF ↗ |
| K151212 | Ziostation2 | Qi Imaging, LLC | 2015-11-04 | Traditional | PDF ↗ |
| K152028 | Volpara Imaging Software | Matakina Technologies Limited | 2015-10-26 | Traditional | PDF ↗ |
| K151988 | Visible Patient Suite | Visible Patient, Sas | 2015-10-15 | Traditional | PDF ↗ |
| K151941 | DEXIS Webview | Imaging Sciences International /Gendex/Dexis | 2015-10-07 | Traditional | PDF ↗ |
| K151501 | OrthoVis Web Portal | Custom Orthopaedic Solutions, Inc. | 2015-10-02 | Traditional | PDF ↗ |
| K151774 | CARESTREAM Vue Motion | Carestream Health, Inc. | 2015-09-21 | Traditional | PDF ↗ |
| K143586 | FACT Medical Imaging Sysytem | Dexin Medical Imaging Technology Co., Ltd. | 2015-09-02 | Traditional | PDF ↗ |
| K151957 | BOX DICOM Viewer | Box, Inc. | 2015-09-01 | Special | PDF ↗ |
| K152186 | HealthMyne PACS | Healthmyne, Inc. | 2015-08-20 | Traditional | PDF ↗ |
| K151371 | Corporate Dental Imaging (CDI) Application | U.S. Army Dental Command (Dencom) | 2015-08-19 | Traditional | PDF ↗ |
| K151837 | CS 3D Imaging | Trophy | 2015-08-19 | Traditional | PDF ↗ |
| K151859 | Synapse Cardiovascular | Fujifilm Medical Systems U.S.A, Inc. | 2015-08-12 | Traditional | PDF ↗ |
| K151850 | McKesson Cardiology | Mckesson Israel , Ltd. | 2015-08-11 | Traditional | PDF ↗ |
| K151353 | syngo.MR Neurology, syngo.MR Oncology | Siemens Medical Solutions USA, Inc. | 2015-08-07 | Traditional | PDF ↗ |
| K151687 | QuantorView | 3Disc Americas | 2015-08-03 | Traditional | PDF ↗ |
| K151568 | Arthrex OrthoVis Preoperative Plan | Custom Orthopaedic Solutions, Inc. | 2015-07-31 | Traditional | PDF ↗ |
| K143368 | GenIQ | Ge Medical Systems, LLC | 2015-07-29 | Traditional | PDF ↗ |
| K151808 | 3D/5D Viewer | Samsung Medison Co., Ltd. | 2015-07-29 | Traditional | PDF ↗ |
| K151854 | 3MP (X213C3P0E, X213G3P0E) and 2MP (X213C2P0E, X213G2P0E) LCD Display | D-View Display Technology Co., Ltd. | 2015-07-28 | Traditional | PDF ↗ |
| K143176 | UltraLinq | Ultralinq Healthcare Solutions, Inc. | 2015-07-17 | Traditional | PDF ↗ |
| K151091 | Vitrea Software Toshiba Package, VSTP-001A | Toshibamedical Systems Corporation | 2015-07-13 | Traditional | PDF ↗ |
| K150313 | Ablation Confirmation | Neuwave Medical, Inc. | 2015-07-09 | Traditional | PDF ↗ |
| K151438 | Dentrix Ascend Imaging | Realcloud Imaging, Inc. | 2015-07-07 | Traditional | PDF ↗ |
| K142750 | JiveX | Visus Technology Transfer GmbH | 2015-06-26 | Traditional | PDF ↗ |
| K151192 | syngo.via MI Workflows | Siemens Medical Solutions USA, Inc. | 2015-06-23 | Traditional | PDF ↗ |
| K150415 | NilRead | Perceptive Software | 2015-06-12 | Traditional | PDF ↗ |
| K150761 | Ez3D-i/E3 | Ewoosoft Co., Ltd. | 2015-06-05 | Special | PDF ↗ |
| K150976 | Collage | Anatomage, Inc. | 2015-06-04 | Traditional | PDF ↗ |
| K151115 | MR Core Software | Vital Images, Inc. | 2015-06-03 | Traditional | PDF ↗ |
| K143397 | ICIS View | Agfa Healthcare N.V. | 2015-06-01 | Traditional | PDF ↗ |
| K150707 | IntelePACS | Intelerad Medical Systems Incorporated | 2015-05-27 | Traditional | PDF ↗ |
| K150420 | Centricity Universal Viewer | GE Healthcare | 2015-05-26 | Traditional | PDF ↗ |
| K150069 | Fine Structure Analysis(fineSA) | Acuitas Medical , Ltd. | 2015-05-22 | Traditional | PDF ↗ |
| K142648 | SPINEDESIGN Spine Surgery Planning (Software Application) | Medtronic Sofamor Danek USA, Inc. | 2015-05-22 | Traditional | PDF ↗ |
| K142196 | Visage Ease Pro | Visage Imaging GmbH | 2015-04-28 | Traditional | PDF ↗ |
| K150843 | syngo®.via (version VB10A) | Siemens AG | 2015-04-24 | Abbreviated | PDF ↗ |
| K142779 | SCANIP; SCANIP: MEDICAL EDITION; SCANIP: MED | Simpleware , Ltd. | 2015-04-17 | Traditional | PDF ↗ |
| K142647 | mint Lesion | Mint Medical GmbH | 2015-04-13 | Traditional | PDF ↗ |
| K150738 | VitreaView | Vital Images, Inc. | 2015-04-06 | Traditional | PDF ↗ |
| K150747 | EzDent-i /E2/Prora View | LK Consulting Group USA, Inc. | 2015-04-02 | Special | PDF ↗ |
| K150192 | Scenium | Siemens Medical Solutions USA, Inc. | 2015-03-29 | Special | PDF ↗ |
| K143361 | Mammo Workstation | GE Healthcare | 2015-03-26 | Traditional | PDF ↗ |
| K150193 | Customer Remote Console (CRC) | Ge Medical Systems, LLC | 2015-03-24 | Traditional | PDF ↗ |
| K142337 | Blackford Analysis Registration Product Family | Blackford Analysis, Ltd. | 2015-03-19 | Traditional | PDF ↗ |
| K143318 | DR Systems Zero Download 3D Viewer (Z3D) | Dr Systems, Inc. | 2015-03-10 | Traditional | PDF ↗ |
| K141536 | VIEWING CLIENT MOBILE | Axon Medical Technologies Corp. | 2015-03-06 | Traditional | PDF ↗ |
| K142923 | TraumaCad Mobile Release 1.0 | Voyant Health, Ltd. | 2015-03-05 | Traditional | PDF ↗ |
| K150258 | Vitrea, Version 7.0 Medical Image Processing Software | Vital Images, Inc. | 2015-03-05 | Special | PDF ↗ |
| K150085 | GE EchoPAC | Ge Vingmed Ultrasound AS | 2015-03-02 | Traditional | PDF ↗ |
| K143319 | Syngo X-workplace SW VD10 | Siemens Medi Cal Solutions, Inc. | 2015-02-24 | Traditional | PDF ↗ |
| K150122 | TOMTEC-ARENA TTA2 | Tomtec Imaging Systems GmbH | 2015-02-13 | Traditional | PDF ↗ |
| K143044 | CAAS A-Valve | Pie Medical Imaging BV | 2015-02-06 | Traditional | PDF ↗ |
| K140828 | NEUROREADER MEDICAL IMAGE PROCESSING SOFTWARE | Brainreader Aps | 2015-02-04 | Traditional | PDF ↗ |
| K142107 | ECHO TRUE 3D VIEWER | Echopixel, Inc. | 2015-01-21 | Traditional | PDF ↗ |
| K141561 | VM PACS WITH VM MEDICAL WORKSTATION | Visual Medica | 2015-01-16 | Traditional | PDF ↗ |
| K142850 | McKesson Radiology Mammography Plus | Mckesson Medical Imaging Company | 2015-01-06 | Traditional | PDF ↗ |
| K140587 | MR-CT VVA | Medis Medical Imaging Systems BV | 2015-01-06 | Traditional | PDF ↗ |
| K142316 | IMPAX Agility | Agfa Healthcare N.V. | 2015-01-06 | Traditional | PDF ↗ |
| K142514 | UniWeb 8.0 | Ebm Technologies Incorporated | 2014-12-18 | Special | PDF ↗ |
| K142891 | HEPATIQ | Hepatiq, LLC | 2014-12-17 | Traditional | PDF ↗ |
| K140860 | ImmersiveTouch3 and MicrovisTouch | Immersivetouch | 2014-12-16 | Traditional | PDF ↗ |
| K142919 | EXA | Viztek, LLC | 2014-12-16 | Special | PDF ↗ |
| K142944 | ArthroPlan Digital Templating Software | Arthromeda, Inc. | 2014-12-16 | Traditional | PDF ↗ |
| K140797 | IPACS MEDICAL IMAGE MANAGEMENT SYSTEM | Visbion Limited | 2014-12-12 | Traditional | PDF ↗ |
| K143254 | eSie Apps Suite | Siemens Medical Solutions USA, Inc. | 2014-12-10 | Traditional | PDF ↗ |
| K142671 | ONEFIT HIP PLANNER | Onefit Medical | 2014-12-05 | Traditional | PDF ↗ |
| K143079 | Endovascular Stent Planning Software | Vital Images, Inc. | 2014-12-04 | Traditional | PDF ↗ |
| K142521 | Synapse 3D Liver and Kidney Analysis | Fujifilm Meidcal Systems U.S.A.,Inc. | 2014-12-01 | Traditional | PDF ↗ |
| K141570 | IMPLANT STUDIO | 3Shape Medical A/S | 2014-10-31 | Traditional | PDF ↗ |
| K141745 | IQQA-BODYIMAGING SOFTWARE | Edda Technology | 2014-10-31 | Traditional | PDF ↗ |
| K141881 | RAPIDRESULTS | Ramsoft, Inc. | 2014-10-31 | Traditional | PDF ↗ |
| K132853 | NOVAPACS | Novarad Corp. | 2014-10-30 | Traditional | PDF ↗ |
| K142037 | QUANTRA | Hologic, Inc. | 2014-10-10 | Traditional | PDF ↗ |
| K141669 | SURGIMAP | Nemaris, Inc. | 2014-09-19 | Traditional | PDF ↗ |
| K140399 | EBM IDO VIEWER | Ebm Technologies USA, LLC | 2014-09-18 | Traditional | PDF ↗ |
| K141607 | DENTAL IMAGING SOFTWARE | Trophy | 2014-09-18 | Traditional | PDF ↗ |
| K142048 | EMPRINT PROCEDURE PLANNING APPLICATION | Covidien, LLC | 2014-09-17 | Traditional | PDF ↗ |
Product code LLZ · Class II · Radiology. Data: openFDA.