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 7 of 23
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K173444 | Quantitative Total Extensible Imaging (QTxI) | Aiq Solutions, Inc. | 2018-07-23 | Traditional | PDF ↗ |
| K180629 | DentiqGuide | 3D Industrial Imaging Co., Ltd. | 2018-07-19 | Traditional | PDF ↗ |
| K173274 | Ceevra Reveal 2.0 | Ceevra, Inc. | 2018-07-10 | Traditional | PDF ↗ |
| K173574 | DenSeeMammo | Statlife | 2018-06-26 | Traditional | PDF ↗ |
| K180815 | MIM - SPECTRA Quant | Mim Software, Inc. | 2018-06-22 | Traditional | PDF ↗ |
| K172346 | sterEOS Workstation | Eos Imaging | 2018-06-19 | Traditional | PDF ↗ |
| K181290 | Fusion Bx 2.0 | Focal Healthcare, Inc. | 2018-06-15 | Special | PDF ↗ |
| K173780 | EchoMD Automated Ejection Fraction Software | Bay Labs, Inc. | 2018-06-14 | Traditional | PDF ↗ |
| K181264 | QLAB Advanced Quantification Software | Philips Ultrasound, Inc. | 2018-06-07 | Traditional | PDF ↗ |
| K181177 | Interventional Workspot | Philips Medical Systems Nederland B.V. | 2018-05-31 | Special | PDF ↗ |
| K181080 | McKesson Cardiology | Change Healthcare Israel , Ltd. | 2018-05-24 | Traditional | PDF ↗ |
| K180883 | 5D Viewer | Samsung Medison Co., Ltd. | 2018-05-15 | Traditional | PDF ↗ |
| K180641 | Invenia ABUS Viewer | GE Healthcare | 2018-05-04 | Traditional | PDF ↗ |
| K173390 | hipEOS | Onefit Medical | 2018-04-27 | Traditional | PDF ↗ |
| K180563 | syngo.plaza | Siemens Healthcare GmbH | 2018-04-25 | Traditional | PDF ↗ |
| K172768 | ZOOM | Zetta Medical Technologies, LLC | 2018-04-24 | Traditional | PDF ↗ |
| K180161 | Viz CTP | Viz. Ai, Inc. | 2018-04-20 | Traditional | PDF ↗ |
| K172477 | iSchemaView RAPID | Ischemaview, Inc. | 2018-04-19 | Traditional | PDF ↗ |
| K180336 | syngo.MR Applications | Siemens Medical Solutions USA, Inc. | 2018-04-19 | Traditional | PDF ↗ |
| K180549 | ZED Link | Zed Technologies | 2018-04-12 | Traditional | PDF ↗ |
| K172998 | uWS-MI | Shanghai United Imaging Healthcare Co., Ltd. | 2018-04-05 | Traditional | PDF ↗ |
| K171847 | Corin Optimized Positioning System (OPS) Plan | Corin U.S.A. Limited | 2018-04-05 | Traditional | PDF ↗ |
| K173897 | syngo.via MI Workflows | Siemens Medical Solutions USA, Inc. | 2018-04-05 | Special | PDF ↗ |
| K180125 | PowerLook Density Assessment Software | Icad, Inc. | 2018-04-05 | Traditional | PDF ↗ |
| K173597 | Scenium VE20 Software | Siemens Medical Solutions USA, Inc. | 2018-04-04 | Special | PDF ↗ |
| K172239 | SIMPLANT 18 | Dentsply Sirona | 2018-04-04 | Traditional | PDF ↗ |
| K180323 | Vitrea Software Package; VSTP-001A | Canon Medical Systems Corporation | 2018-03-30 | Traditional | PDF ↗ |
| K173241 | MED-TAB | Plum Medical Solutions GmbH | 2018-03-23 | Traditional | PDF ↗ |
| K180192 | Emprint Ablation Visualization Application | Covidien, LLC | 2018-03-21 | Traditional | PDF ↗ |
| K172168 | WillCeph | Hdx Will Corp. | 2018-03-21 | Traditional | PDF ↗ |
| K173619 | Mimics inPrint | Materialise NV | 2018-03-21 | Traditional | PDF ↗ |
| K180129 | Imbio Segmentation Editing Tool software | Imbio, LLC | 2018-03-16 | Traditional | PDF ↗ |
| K173611 | syngo Application Software | Siemens Medical Solutions USA, Inc. | 2018-03-16 | Traditional | PDF ↗ |
| K180262 | SICAT Endo | Sicat GmbH & Co. KG | 2018-03-12 | Traditional | PDF ↗ |
| K180394 | BrightMatter Plan 1.6.0 | Synaptive Medical, Inc. | 2018-03-09 | Traditional | PDF ↗ |
| K173939 | Quantib Brain | Quantib B.V. | 2018-03-09 | Traditional | PDF ↗ |
| K180326 | icobrain | Icometrix | 2018-03-08 | Special | PDF ↗ |
| K173605 | iQMR | Medic Vision - Imaging Solutions, Ltd. | 2018-03-08 | Traditional | PDF ↗ |
| K173312 | ProBx Software | Harmonus, Inc. | 2018-03-02 | Traditional | PDF ↗ |
| K173145 | CereMetrix Silver | Ceremetrix Corp | 2018-02-28 | Traditional | PDF ↗ |
| K170540 | DM-Density | Densitas, Inc. | 2018-02-23 | Traditional | PDF ↗ |
| K173863 | Ez3D-i /E3 | Ewoosoft Co., Ltd. | 2018-02-23 | Special | PDF ↗ |
| K173636 | Velocity | Varian Medical Systems, Inc. | 2018-02-15 | Traditional | PDF ↗ |
| K170793 | SuRgical Planner (SRP) | Surgical Theater, LLC | 2018-02-12 | Traditional | PDF ↗ |
| K180091 | UNiD Spine Analyzer | Medicrea International | 2018-02-08 | Special | PDF ↗ |
| K162727 | SENYINT Remote Consultation System | Dalian Senyint Digital Medical System Co., Ltd. | 2018-02-08 | Traditional | PDF ↗ |
| K172832 | Insight BD | Siemens Medi Cal Solutions, Inc. | 2018-02-06 | Traditional | PDF ↗ |
| K172490 | eUnity | Client Outlook, Inc. | 2018-02-06 | Traditional | PDF ↗ |
| K173512 | MFI-Cardiac | Multifunctional Imaging, LLC | 2018-02-05 | Traditional | PDF ↗ |
| K173088 | Vitrea Software Toshiba Package VSTP-001A | Toshibamedical Systems Corporation | 2018-01-31 | Traditional | PDF ↗ |
| K173542 | Arterys Oncology DL | Arterys, Inc. | 2018-01-25 | Traditional | PDF ↗ |
| K173622 | CS Imaging | Trophy | 2018-01-16 | Traditional | PDF ↗ |
| K173054 | Navigo Workstation Version 2.0 | UC-CARE , Ltd. | 2018-01-16 | Traditional | PDF ↗ |
| K173588 | Illumeo System | Philips Medical Systems Technologies , Ltd. | 2018-01-12 | Special | PDF ↗ |
| K172224 | DTX Studio diagnose | Nobel Biocare AB | 2018-01-11 | Traditional | PDF ↗ |
| K171328 | cNeuro cMRI | Combinostics OY | 2018-01-08 | Traditional | PDF ↗ |
| K173456 | ViewPoint 6 | Ge Medical Systems Ultrasound and Primary | 2018-01-05 | Traditional | PDF ↗ |
| K173420 | Radiomics App v1.0 | Microsoft Corp. | 2017-12-27 | Traditional | PDF ↗ |
| K173467 | Advanced Diffusion Analysis (ADA) application | Philips Medical Systems Nederland B.V. | 2017-12-12 | Traditional | PDF ↗ |
| K173475 | Merge PACS | Merge Healthcare Incorporated | 2017-12-08 | Traditional | PDF ↗ |
| K172218 | MIM Y90 Dosimetry | Mim Software, Inc. | 2017-11-21 | Traditional | PDF ↗ |
| K173378 | syngo®.via protoNeo (Version VA20) | Siemens Healthcare GmbH | 2017-11-20 | Traditional | PDF ↗ |
| K173329 | jFit Surgical Planner | Jointvue, LLC | 2017-11-15 | Traditional | PDF ↗ |
| K171385 | Planmeca Romexis | Planmeca Oy | 2017-11-14 | Traditional | PDF ↗ |
| K173247 | Surgical Planning Software version 1.1 | Ortho Kinematics, Inc. | 2017-11-08 | Special | PDF ↗ |
| K172803 | Infinitt PACS 7.0 | Infinitt Healthcare Co., Ltd. | 2017-10-27 | Traditional | PDF ↗ |
| K173094 | OrthoVision | Ewoosoft Co., Ltd. | 2017-10-26 | Special | PDF ↗ |
| K171709 | BR-FHUS Viewer 1.0 | Taihao Medical, Inc. | 2017-10-20 | Traditional | PDF ↗ |
| K163623 | Quantra | Hologic, Inc. | 2017-10-20 | Traditional | PDF ↗ |
| K171068 | OrthoView 7.2 | Meridian Technique, Ltd. | 2017-10-18 | Traditional | PDF ↗ |
| K173101 | Curve Image 2.0 PACS | Curve Dental, Ltd. | 2017-10-18 | Special | PDF ↗ |
| K172855 | Vitrea Advanced Visualization, Version 7.6 | Vital Images, Inc. | 2017-10-05 | Special | PDF ↗ |
| K171463 | ASPIRE Bellus II | Fujifilm Medical Systems U.S.A, Inc. | 2017-09-29 | Traditional | PDF ↗ |
| K170816 | Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature Correction, Elements TRAM | Brainlab AG | 2017-09-26 | Traditional | PDF ↗ |
| K172513 | 3D Echo | Jointvue, LLC | 2017-09-14 | Traditional | PDF ↗ |
| K170981 | NeuroQuant | Cortechs Labs, Inc. | 2017-09-07 | Traditional | PDF ↗ |
| K172327 | VMA System version 3.0 | Ortho Kinematics, Inc. | 2017-08-25 | Traditional | PDF ↗ |
| K171617 | OKI Surgical Planning Software | Ortho Kinematics, Inc. | 2017-08-22 | Traditional | PDF ↗ |
| K172364 | EzDent-i / E2 / Prora View | Ewoosoft Co., Ltd. | 2017-08-22 | Traditional | PDF ↗ |
| K171356 | Clarity Reveal | Ceevra, Inc. | 2017-08-03 | Traditional | PDF ↗ |
| K163048 | Smart Stitching Software System, Image Processing, Radiological | Osko, Inc. | 2017-07-28 | Traditional | PDF ↗ |
| K171754 | NovaPACS | Novarad Corporation | 2017-07-28 | Traditional | PDF ↗ |
| K170841 | BiopSee, Mobile US | Medcom GmbH | 2017-07-26 | Traditional | PDF ↗ |
| K163232 | Vitrea View | Vital Images, Inc. | 2017-07-21 | Traditional | PDF ↗ |
| K170729 | Examion X-AQS | Examion GmbH | 2017-07-18 | Traditional | PDF ↗ |
| K171544 | Arterys Viewer | Arterys, Inc. | 2017-07-18 | Traditional | PDF ↗ |
| K171115 | 3D Endo Software | Dentsply Sirona | 2017-07-17 | Traditional | PDF ↗ |
| K170434 | Enterprise Imaging XERO Viewer 8.1 | Agfa Healthcare N.V. | 2017-07-03 | Traditional | PDF ↗ |
| K163668 | SUITESTENSA | Ebit Srl | 2017-06-23 | Traditional | PDF ↗ |
| K170847 | EchoPAC Software Only, EchoPAC Plug-in | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2017-06-14 | Traditional | PDF ↗ |
| K170747 | syngo Application Software | Siemens Medical Solutions USA, Inc. | 2017-06-09 | Traditional | PDF ↗ |
| K171222 | Vitrea Software Toshiba Package; VSTP-001A | Toshibamedical Systems Corporation | 2017-06-08 | Traditional | PDF ↗ |
| K170250 | SmartTarget | Smarttarget, Ltd. | 2017-06-07 | Traditional | PDF ↗ |
| K171053 | syngo Dynamics Version VA30 | Siemens Healthcare GmbH | 2017-06-01 | Traditional | PDF ↗ |
| K162574 | AmCAD-US | Amcad Biomed Corporation | 2017-05-30 | Traditional | PDF ↗ |
| K171314 | QLAB Advanced Quantification Software | Philips Health Care | 2017-05-30 | Traditional | PDF ↗ |
| K170172 | UNiD Spine Analyzer | Medicrea International | 2017-05-24 | Traditional | PDF ↗ |
| K163071 | vascuCAP | Elucid Bioimaging, Inc. | 2017-05-24 | Traditional | PDF ↗ |
| K170195 | QuantX | Quantitative Insights, Inc. | 2017-05-17 | Traditional | PDF ↗ |
| K161601 | Dynamika | Image Analysis Limited | 2017-05-17 | Traditional | PDF ↗ |
Product code LLZ · Class II · Radiology. Data: openFDA.