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 5 of 23
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K202487 | HealthJOINT | Zebra Medical Vision, Ltd. | 2020-12-04 | Traditional | PDF ↗ |
| K203249 | Nucleus.io | Nucleushealth, LLC | 2020-12-04 | Traditional | PDF ↗ |
| K200572 | Planmeca Romexis | Planmeca Oy | 2020-12-02 | Traditional | PDF ↗ |
| K202805 | Optimized Positioning System (OPS) Insight | Corin USA | 2020-11-20 | Traditional | PDF ↗ |
| K193287 | CorInsights MRI | Adm Diagnostics, Inc. | 2020-11-20 | Traditional | PDF ↗ |
| K203156 | DTX Studio Clinic | Nobel Biocare AB | 2020-11-20 | Traditional | PDF ↗ |
| K203287 | DBSWIN, VISTAEASY | Dürr Dental SE | 2020-11-18 | Special | PDF ↗ |
| K193306 | PROView | GE Medical Systems SCS | 2020-11-17 | Traditional | PDF ↗ |
| K200750 | Neuro.Al Algorithm | Terarecon,Inc. | 2020-11-06 | Special | PDF ↗ |
| K200350 | MyHip Planner & Verifier | Medacta International S.A. | 2020-11-04 | Traditional | PDF ↗ |
| K203058 | CloudVue | International Medical Solutions, Inc. | 2020-10-29 | Traditional | PDF ↗ |
| K202519 | OrthoNext Platform System | Orthofix Srl | 2020-10-27 | Traditional | PDF ↗ |
| K202948 | EzOrtho | Ewoosoft Co., Ltd. | 2020-10-22 | Special | PDF ↗ |
| K201710 | A View LCS | Coreline Soft Co., Ltd. | 2020-10-16 | Traditional | PDF ↗ |
| K202501 | Quantib Prostate | Quantib B.V. | 2020-10-11 | Traditional | PDF ↗ |
| K200810 | IPS CaseDesigner | Nobel Biocare AB | 2020-10-08 | Traditional | PDF ↗ |
| K202292 | UDE | Ebm Technologies, Inc. | 2020-10-05 | Traditional | PDF ↗ |
| K202280 | Cleerly Labs v2.0 | Cleerly, Inc. | 2020-10-02 | Traditional | PDF ↗ |
| K192051 | THINQ | Corticometrics, LLC | 2020-09-30 | Traditional | PDF ↗ |
| K201928 | e-Ortho Shoulder Software | FH Industrie | 2020-09-30 | Traditional | PDF ↗ |
| K201103 | Xeleris V Processing and Review Systems | GE Healthcare | 2020-09-25 | Traditional | PDF ↗ |
| K200603 | AAA Model | Philips Ultrasound, Inc. | 2020-09-20 | Traditional | PDF ↗ |
| K192890 | SentEP | Sentiar, Inc. | 2020-09-18 | Traditional | PDF ↗ |
| K200852 | EchoPAC Software Only, EchoPAC Plug-In | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2020-09-18 | Traditional | PDF ↗ |
| K201369 | AVA (Augmented Vascular Analysis) | See-Mode Technologies Pte, Ltd. | 2020-09-16 | Traditional | PDF ↗ |
| K201665 | Collaboration Live | Philips Ultrasound, Inc. | 2020-09-15 | Traditional | PDF ↗ |
| K202297 | Aline Ablation Intelligence | Mirada Medical, Ltd. | 2020-09-11 | Traditional | PDF ↗ |
| K201948 | AcroDTI Visualizer | Acroviz, Inc. | 2020-09-09 | Traditional | PDF ↗ |
| K202256 | 3Shape Implant Studio | 3Shape Medical A/S | 2020-09-09 | Traditional | PDF ↗ |
| K202335 | Ambra ProViewer | Dicom Grid Inc Dba Ambra Health | 2020-09-04 | Traditional | PDF ↗ |
| K200973 | Synapse 3D Cardiac Tools | Fujifilm Corporaton | 2020-08-27 | Traditional | PDF ↗ |
| K200714 | AVIEW | Coreline Soft Co., Ltd. | 2020-08-26 | Traditional | PDF ↗ |
| K202116 | EzDent-i/ E2/ Prora View/ Smart M Viewer | Ewoosoft Co., Ltd. | 2020-08-21 | Special | PDF ↗ |
| K201352 | 3D Auto LAA | Philips Health Care | 2020-08-17 | Traditional | PDF ↗ |
| K201632 | TOMTEC-ARENA | Tomtec Imaging Systems GmbH | 2020-08-14 | Traditional | PDF ↗ |
| K201232 | Limbus Contour | Limbus Ai, Inc. | 2020-08-13 | Traditional | PDF ↗ |
| K200822 | Braid | Braid.Health | 2020-08-13 | Traditional | PDF ↗ |
| K201465 | SuRgical Planner (SRP) BrainStorm | Surgical Theater, Inc. | 2020-07-17 | Traditional | PDF ↗ |
| K201365 | True 3D Viewer | Echopixel, Inc. | 2020-07-17 | Traditional | PDF ↗ |
| K193294 | AI-Rad Companion Engine | Siemens Medical Solutions USA, Inc. | 2020-07-10 | Traditional | PDF ↗ |
| K201296 | i-Rapha Solution | Irm, Inc. | 2020-07-09 | Traditional | PDF ↗ |
| K201477 | syngo.via View&GO | Siemens Healthcare GmbH | 2020-07-01 | Special | PDF ↗ |
| K193042 | Optimized Positioning System (OPS) ReView | Corin USA | 2020-06-26 | Traditional | PDF ↗ |
| K193290 | AI-Rad Companion Brain MR | Siemens Medical Solutions USA, Inc. | 2020-06-17 | Traditional | PDF ↗ |
| K200899 | Quantib AI Node | Quantib B.V. | 2020-06-15 | Traditional | PDF ↗ |
| K192630 | uWS-MI | Shanghai United Imaging Healthcare Co., Ltd. | 2020-06-11 | Traditional | PDF ↗ |
| K201202 | MI View&GO | Siemens Medical Solutions USA, Inc. | 2020-06-02 | Special | PDF ↗ |
| K192692 | Brainomix 360 e-CTA | Brainomix Limited | 2020-05-28 | Traditional | PDF ↗ |
| K200274 | CariCloud | Caristo Diagnostics | 2020-05-21 | Traditional | PDF ↗ |
| K201062 | syngo Ultrasound Apps Suite (sUSAS) | Siemens Medical Solutions USA, Inc. | 2020-05-18 | Special | PDF ↗ |
| K200546 | ZeeroMED View | O3 Enterprise Srl | 2020-05-05 | Traditional | PDF ↗ |
| K193220 | AVIEW LCS | Coreline Soft Co., Ltd. | 2020-05-05 | Traditional | PDF ↗ |
| K200315 | Ziostation2 | Ziosoft, Inc. | 2020-05-05 | Traditional | PDF ↗ |
| K192656 | Optimized Positioning System (OPS) Insight | Corin USA | 2020-05-01 | Traditional | PDF ↗ |
| K193523 | ArthrexVIP Web Portal | Arthrex, Inc. | 2020-04-30 | Special | PDF ↗ |
| K192475 | NemoFAB | Software Nemotec S.L. | 2020-04-23 | Traditional | PDF ↗ |
| K193369 | Xelis Dental 2.0 | Infinitt Healthcare Co., Ltd. | 2020-04-14 | Traditional | PDF ↗ |
| K200703 | JiveX | Visus Health IT GmbH | 2020-04-14 | Traditional | PDF ↗ |
| K200078 | VARO Plan | 3D Industrial Imaging Co., Ltd. | 2020-04-10 | Traditional | PDF ↗ |
| K200713 | EchoNavigator | Philips Medical Systems Nederland B.V. | 2020-04-09 | Special | PDF ↗ |
| K192176 | IntelePACS | Intelerad Medical Systems Incorporated | 2020-04-02 | Traditional | PDF ↗ |
| K190767 | AnatomicAligner | The Methodist Hospital Research Institute D/B/A Houston | 2020-03-16 | Traditional | PDF ↗ |
| K192888 | EzOrtho | Ewoosoft Co., Ltd. | 2020-03-13 | Traditional | PDF ↗ |
| K190993 | Kinepict Medical Imaging Tool version v2.2 | Kinepict Health, Ltd. | 2020-03-05 | Traditional | PDF ↗ |
| K192962 | icobrain-ctp | Icometrix NV | 2020-02-28 | Traditional | PDF ↗ |
| K200178 | Ez3D-i /E3 | Ewoosoft Co., Ltd. | 2020-02-25 | Special | PDF ↗ |
| K192973 | densitas densityai | Densitas, Inc. | 2020-02-19 | Special | PDF ↗ |
| K200179 | Collaboration Live | Philips Health Care | 2020-02-18 | Traditional | PDF ↗ |
| K200132 | Ashvins | Medicalcommunications GmbH | 2020-02-18 | Traditional | PDF ↗ |
| K192923 | Vitrea Software Package | Canon Medical Systems Corporation | 2020-02-14 | Traditional | PDF ↗ |
| K192372 | ASCEND Image Viewer | Ascend Hit | 2020-02-14 | Traditional | PDF ↗ |
| K193498 | Infinitt RT PACS | Infinitt Healthcare Co., Ltd. | 2020-02-13 | Traditional | PDF ↗ |
| K192165 | Acteon Imaging Suite | De Gotzen S.R.L. | 2020-02-11 | Traditional | PDF ↗ |
| K192462 | syngo.MR Applications | Siemens Medical Solutions USA, Inc. | 2020-01-31 | Traditional | PDF ↗ |
| K193261 | FlightPlan for Embolization | GE Medical Systems SCS | 2020-01-24 | Traditional | PDF ↗ |
| K191014 | Elements Viewer | Brainlab AG | 2020-01-23 | Traditional | PDF ↗ |
| K192098 | EzMobile | Ewoosoft Co., Ltd. | 2020-01-20 | Traditional | PDF ↗ |
| K191125 | ADAS 3D | Galgo Medical S.L | 2020-01-15 | Traditional | PDF ↗ |
| K192917 | ViewPoint 6 | Ge Medical Systems Ultrasound And | 2020-01-06 | Traditional | PDF ↗ |
| K192912 | AutoMIStar | Apollo Medical Imaging Technology Pty. , Ltd. | 2019-12-31 | Traditional | PDF ↗ |
| K193149 | True 3D Viewer Software | Echopixel, Inc. | 2019-12-27 | Traditional | PDF ↗ |
| K193403 | UroNav System | Invivo Corporation | 2019-12-27 | Traditional | PDF ↗ |
| K192040 | AVIEW Modeler | Coreline Soft Co., Ltd. | 2019-12-20 | Traditional | PDF ↗ |
| K183676 | DentiqAir | 3D Industrial Imaging Co., Ltd. | 2019-12-19 | Traditional | PDF ↗ |
| K192531 | QyScore Software | Qynapse | 2019-12-13 | Traditional | PDF ↗ |
| K192130 | Icobrain | Icometrix NV | 2019-12-13 | Traditional | PDF ↗ |
| K192571 | NemoScan | Software Nemotec S.L. | 2019-12-11 | Traditional | PDF ↗ |
| K192279 | PhantomMSK Trauma | OrthoGrid Systems, Inc. | 2019-12-07 | Traditional | PDF ↗ |
| K192348 | SICAT Implant V2.0 | Sicat GmbH & Co. KG | 2019-12-04 | Traditional | PDF ↗ |
| K192038 | Emprint Visualization Application | Covidien, LLC | 2019-12-02 | Traditional | PDF ↗ |
| K192508 | Medsynapse Ris Pacs & Medsynapse VNA | Medsynaptic Private, Ltd. | 2019-11-22 | Traditional | PDF ↗ |
| K191278 | RSI-MRI+ | Multimodal Imaging Services Corporation (Dba Healthlytix) | 2019-11-19 | Traditional | PDF ↗ |
| K191959 | QuantX Breast MRI Biopsy Guidance Plugin | Qlarity Imaging | 2019-11-08 | Traditional | PDF ↗ |
| K191026 | MEDIP PRO | Medical IP Co., Ltd. | 2019-11-07 | Traditional | PDF ↗ |
| K190868 | Cleerly Labs | Cleerly, Inc. | 2019-11-05 | Traditional | PDF ↗ |
| K192109 | KOALA | Ib Lab GmbH | 2019-11-05 | Traditional | PDF ↗ |
| K183412 | mediCAD Web | Medicad Hectec GmbH | 2019-10-31 | Traditional | PDF ↗ |
| K192743 | VisionX 2.4 | Durr Dental SE | 2019-10-31 | Traditional | PDF ↗ |
| K191544 | Synapse 3D Blood Flow Analysis | Fujifilm Corporation | 2019-10-18 | Traditional | PDF ↗ |
| K192455 | Merge PACS | Merge Healthcare Incorporated | 2019-10-17 | Traditional | PDF ↗ |
Product code LLZ · Class II · Radiology. Data: openFDA.