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 6 of 23
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K192455 | Merge PACS | Merge Healthcare Incorporated | 2019-10-17 | Traditional | PDF ↗ |
| K191216 | Voxel Dosimetry v1.0 | Hermes Medical Solutions AB | 2019-10-17 | Traditional | PDF ↗ |
| K191493 | Ventripoint Medical System Plus (VMS+) 3.0 | Ventripoint Diagnostics , Ltd. | 2019-10-16 | Traditional | PDF ↗ |
| K192200 | DynaCAD | Invivo Corporation | 2019-10-09 | Traditional | PDF ↗ |
| K191610 | RTapp | Segana, LLC | 2019-10-01 | Traditional | PDF ↗ |
| K191530 | StoneChecker | Imaging Biometrics, LLC | 2019-09-26 | Traditional | PDF ↗ |
| K192435 | NuVasive NuvaLine | Nu Vasive, Incorporated | 2019-09-26 | Traditional | PDF ↗ |
| K192276 | Merge Cardio | Merge Healthcare Incorporated | 2019-09-20 | Traditional | PDF ↗ |
| K191688 | SubtleMR | Subtle Medical, Inc. | 2019-09-16 | Traditional | PDF ↗ |
| K192304 | SIS Software Version 3.6.0 | Surgical Information Sciences, Inc. | 2019-09-13 | Special | PDF ↗ |
| K190780 | syngo Application Software | Siemens Medical Solution USA, Inc. | 2019-09-12 | Traditional | PDF ↗ |
| K183489 | D2P | 3D Systems, Inc. | 2019-08-29 | Traditional | PDF ↗ |
| K183544 | Efficient Care 3D Planning | Orthosoft Inc (D/B/A Zimmer Cas) | 2019-08-23 | Traditional | PDF ↗ |
| K183458 | exoplan 2.3 | Exocad GmbH | 2019-08-06 | Traditional | PDF ↗ |
| K191262 | aBSI | Exini Diagnostics AB | 2019-08-05 | Traditional | PDF ↗ |
| K183193 | MREplus+ Software | Resoundant, Inc. | 2019-08-01 | Traditional | PDF ↗ |
| K191309 | syngo.via MI Workflows VB40A, Scenium | Siemens Medical Soultions USA, Inc. | 2019-07-19 | Special | PDF ↗ |
| K191585 | iNtuition-Structural Heart Module | Terarecon,Inc. | 2019-07-12 | Traditional | PDF ↗ |
| K190694 | Unifi Workspace v1.0.0 | Hologic, Inc. | 2019-07-11 | Traditional | PDF ↗ |
| K182904 | syngo.MR Applications | Siemens Medical Solutions USA, Inc. | 2019-07-05 | Traditional | PDF ↗ |
| K190096 | R2GATE | Megagen Implant Co., Ltd. | 2019-06-26 | Traditional | PDF ↗ |
| K183170 | uWS-CT | Shanghai United Imaging Healthcare Co., Ltd. | 2019-06-24 | Traditional | PDF ↗ |
| K190913 | QLAB Advanced Quantification Software 13 | Philips Health Care | 2019-06-18 | Special | PDF ↗ |
| K183460 | ClariCT.AI | Claripi, Inc. | 2019-06-13 | Traditional | PDF ↗ |
| K190874 | Materialise Mimics Enlight | Materialise NV | 2019-06-05 | Traditional | PDF ↗ |
| K191188 | ASHK100G | Lg Electronics | 2019-05-30 | Traditional | PDF ↗ |
| K191040 | syngo.via (Version VB40A) | Siemens Healthcare GmbH | 2019-05-16 | Abbreviated | PDF ↗ |
| K190764 | SurgicalAR | Medivis, Inc. | 2019-05-13 | Traditional | PDF ↗ |
| K190866 | XmaruView V1 (Xmaru Chiroview, Xmaru Podview) | Rayence Co., Ltd. | 2019-04-30 | Special | PDF ↗ |
| K183248 | Synapse Enterprise Viewer Version 1.0 | Fujifilm Corporation | 2019-04-25 | Traditional | PDF ↗ |
| K190042 | Brainlab Elements Image Fusion Angio | Brainlab AG | 2019-04-25 | Traditional | PDF ↗ |
| K190791 | Ez3D-i/E3 | Ewoosoft Co., Ltd. | 2019-04-19 | Special | PDF ↗ |
| K183593 | Lung Vision System | Bodyvision Medical , Ltd. | 2019-04-18 | Traditional | PDF ↗ |
| K190420 | NDOHD High Definition Imaging System (NDOHD) | Altaravision, Inc. | 2019-04-15 | Special | PDF ↗ |
| K182572 | InstaRISPACS / InstaZFP / InstaMobi v5.0 | Meddiff Technologies Pvt. , Ltd. | 2019-04-12 | Special | PDF ↗ |
| K190629 | DBSWIN and VISTAEASY Imaging Software | Durr Dental SE | 2019-04-01 | Traditional | PDF ↗ |
| K183210 | Thoracic VCAR with GSI Pulmonary Perfusion | GE Medical Systems SCS | 2019-03-29 | Traditional | PDF ↗ |
| K183105 | Mimics Medical | Materialise NV | 2019-03-27 | Traditional | PDF ↗ |
| K190232 | Synapse PACS | Fujifilm Corporation | 2019-03-26 | Traditional | PDF ↗ |
| K183164 | uWS-MR | Shanghai United Imaging Healthcare Co., Ltd. | 2019-03-22 | Traditional | PDF ↗ |
| K183019 | SIS Software version 3.3.0 | Surgical Information Sciences, Inc. | 2019-03-19 | Traditional | PDF ↗ |
| K190379 | MIM on Linux | Mim Software, Inc. | 2019-03-19 | Special | PDF ↗ |
| K182537 | RADMAX Digital Imaging Software | DRGEM Corporation | 2019-03-08 | Traditional | PDF ↗ |
| K182966 | PLANET Onco Dose | Dosisoft | 2019-03-06 | Traditional | PDF ↗ |
| K181859 | Visualase Thermal Therapy System | Medtronic Navigation, Inc. | 2019-03-06 | Special | PDF ↗ |
| K183478 | ClearON Mobile | Rayence Co., Ltd. | 2019-03-01 | Special | PDF ↗ |
| K190087 | EzDent-i / E2 / Prora View | Ewoosoft Co., Ltd. | 2019-02-27 | Traditional | PDF ↗ |
| K182643 | IRIS 1.0 System | Intuitive Surgical | 2019-02-22 | Traditional | PDF ↗ |
| K182332 | PhantomMSK | OrthoGrid Systems, Inc. | 2019-02-15 | Traditional | PDF ↗ |
| K190074 | Presero 3D Scanning System | Certis Health | 2019-02-14 | Traditional | PDF ↗ |
| K183272 | AI Rad Companion (Engine) | Siemens Medical Solutions USA, Inc. | 2019-02-01 | Traditional | PDF ↗ |
| K183133 | MRCP+ v1.0 | Perspectum Diagnostics, Ltd. | 2019-01-09 | Traditional | PDF ↗ |
| K182855 | ProKnow DS | Proknow, LLC | 2019-01-02 | Traditional | PDF ↗ |
| K180867 | AmCAD-UO | Amcad Biomed Corporation | 2018-12-28 | Traditional | PDF ↗ |
| K182564 | Quantib ND | Quantib B.V. | 2018-12-27 | Traditional | PDF ↗ |
| K182130 | iSchemaView RAPID | Ischemaview, Inc. | 2018-12-27 | Traditional | PDF ↗ |
| K182750 | 4D View | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2018-12-21 | Traditional | PDF ↗ |
| K183012 | vascuCAP | Elucid Bioimaging, Inc. | 2018-12-21 | Traditional | PDF ↗ |
| K173041 | 3DIEMME RealGUIDE | 3Diemme , Ltd. | 2018-12-20 | Traditional | PDF ↗ |
| K182624 | MIM - MRT Dosimetry | Mim Software, Inc. | 2018-12-18 | Traditional | PDF ↗ |
| K182601 | Vitrea Software Package, VSTP-001A | Canon Medical Systems Corporation | 2018-12-14 | Traditional | PDF ↗ |
| K182419 | Centricity Universal Viewer | GE Healthcare | 2018-12-14 | Traditional | PDF ↗ |
| K182359 | HipCheck | Stryker Corp. | 2018-12-13 | Traditional | PDF ↗ |
| K182016 | Simplicit90Y | Mirada Medical, Ltd. | 2018-12-06 | Traditional | PDF ↗ |
| K182926 | IntelliSpace Radiology | Philips Healthcare Informatics, Inc. | 2018-12-06 | Traditional | PDF ↗ |
| K181825 | CAAS MR Solutions | Pie Medical Imaging BV | 2018-12-04 | Traditional | PDF ↗ |
| K173083 | IMPLANTER DENTAL PLANNING SOFTWARE | Implanter, LLC | 2018-12-03 | Traditional | PDF ↗ |
| K182815 | XVWeb 3D | Apteryx, Inc. | 2018-11-30 | Special | PDF ↗ |
| K182431 | Konicaminolta DI-X1 | Konica Minolta, Inc. | 2018-11-26 | Traditional | PDF ↗ |
| K183038 | Corin Optimized Positioning System (OPS) Plan | Corin USA | 2018-11-26 | Traditional | PDF ↗ |
| K183013 | Vitrea Software Package, VSTP-001A | Canon Medical Systems Corporation | 2018-11-26 | Special | PDF ↗ |
| K173744 | ProFuse CAD | Eigen | 2018-11-21 | Traditional | PDF ↗ |
| K181247 | Vitrea CT Brain Perfusion | Vital Images, Inc. | 2018-11-20 | Traditional | PDF ↗ |
| K172999 | uWS-MR | Shanghai United Imaging Healthcare Co., Ltd. | 2018-11-07 | Traditional | PDF ↗ |
| K173001 | uWS-CT | Shanghai United Imaging Healthcare Co., Ltd. | 2018-11-07 | Traditional | PDF ↗ |
| K181939 | icobrain | Icometrix NV | 2018-11-06 | Traditional | PDF ↗ |
| K171199 | AVIEW | Coreline Soft Co., Ltd. | 2018-10-31 | Traditional | PDF ↗ |
| K173965 | Implant Planning Software | Inteware Co., Ltd. | 2018-10-26 | Traditional | PDF ↗ |
| K182464 | PeekMed | Peek Health, S.A. | 2018-10-25 | Traditional | PDF ↗ |
| K181964 | JiveX | Visus Health IT GmbH | 2018-10-23 | Traditional | PDF ↗ |
| K182561 | UroNav (Version 3.0) | Invivo Corporation | 2018-10-19 | Traditional | PDF ↗ |
| K182034 | Arterys MICA | Arterys, Inc. | 2018-10-17 | Traditional | PDF ↗ |
| K181460 | OnePacs System | Onepacs, LLC | 2018-10-11 | Traditional | PDF ↗ |
| K181892 | Ziostation2 | Ziosoft, Inc. | 2018-10-09 | Traditional | PDF ↗ |
| K182290 | IBM iConnect Access | Merge Healthcare Incorporated | 2018-09-25 | Traditional | PDF ↗ |
| K181773 | Synapse 3D Optional Tools | Fujifilm Corporation | 2018-09-25 | Traditional | PDF ↗ |
| K180916 | iNtuition-T1 Mapping and T2/T2* Mapping | Terarecon,Inc. | 2018-09-24 | Traditional | PDF ↗ |
| K182310 | Volpara Imaging Software | Volpara Health Technologies Limited | 2018-09-21 | Special | PDF ↗ |
| K172418 | OpenSight | Novarad Corporation | 2018-09-21 | Traditional | PDF ↗ |
| K181926 | InVivo Web Viewer | Anatomage, Inc. | 2018-09-21 | Traditional | PDF ↗ |
| K182230 | Multi Modality Viewer | Vital Images, Inc. | 2018-09-07 | Traditional | PDF ↗ |
| K182208 | syngo.via View&GO (Version VA10A) | Siemens Healthcare GmbH | 2018-09-07 | Abbreviated | PDF ↗ |
| K170702 | mediCAD 4.0 | Medicad Hectec GmbH | 2018-09-07 | Traditional | PDF ↗ |
| K180006 | AmCAD-UT Detection 2.2 | Amcad Biomed Corporation | 2018-08-31 | Traditional | PDF ↗ |
| K181185 | Change Healthcare Enterprise Viewer | Change Healthcare Canada Company | 2018-08-29 | Traditional | PDF ↗ |
| K180522 | IGTFusion | Igi Technologies | 2018-08-16 | Traditional | PDF ↗ |
| K181318 | ONIS-PACS | Digitalcore Co., Ltd. | 2018-08-13 | Traditional | PDF ↗ |
| K181962 | CubeVue | Curvebeam, LLC | 2018-08-07 | Traditional | PDF ↗ |
| K171435 | VirtuOst Vertebral Fracture Assessment | O.N. Diagnostics, LLC | 2018-08-03 | Traditional | PDF ↗ |
| K171977 | miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP Viewer | Hinacom Software and Technology, Ltd. | 2018-08-02 | Traditional | PDF ↗ |
Product code LLZ · Class II · Radiology. Data: openFDA.