LLZ
2,283 FDA 510(k) clearances · Product code
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| Record | Firm | Date |
|---|---|---|
| syngo Application Software (K190780) | Siemens Medical Solution USA, Inc. | 2019-09-12 |
| D2P (K183489) | 3D Systems, Inc. | 2019-08-29 |
| Efficient Care 3D Planning (K183544) | Orthosoft Inc (D/B/A Zimmer Cas) | 2019-08-23 |
| exoplan 2.3 (K183458) | Exocad GmbH | 2019-08-06 |
| aBSI (K191262) | Exini Diagnostics AB | 2019-08-05 |
| MREplus+ Software (K183193) | Resoundant, Inc. | 2019-08-01 |
| syngo.via MI Workflows VB40A, Scenium (K191309) | Siemens Medical Soultions USA, Inc. | 2019-07-19 |
| iNtuition-Structural Heart Module (K191585) | Terarecon,Inc. | 2019-07-12 |
| Unifi Workspace v1.0.0 (K190694) | Hologic, Inc. | 2019-07-11 |
| syngo.MR Applications (K182904) | Siemens Medical Solutions USA, Inc. | 2019-07-05 |
| R2GATE (K190096) | Megagen Implant Co., Ltd. | 2019-06-26 |
| uWS-CT (K183170) | Shanghai United Imaging Healthcare Co., Ltd. | 2019-06-24 |
| QLAB Advanced Quantification Software 13 (K190913) | Philips Health Care | 2019-06-18 |
| ClariCT.AI (K183460) | Claripi, Inc. | 2019-06-13 |
| Materialise Mimics Enlight (K190874) | Materialise NV | 2019-06-05 |
| ASHK100G (K191188) | Lg Electronics | 2019-05-30 |
| syngo.via (Version VB40A) (K191040) | Siemens Healthcare GmbH | 2019-05-16 |
| SurgicalAR (K190764) | Medivis, Inc. | 2019-05-13 |
| XmaruView V1 (Xmaru Chiroview, Xmaru Podview) (K190866) | Rayence Co., Ltd. | 2019-04-30 |
| Synapse Enterprise Viewer Version 1.0 (K183248) | Fujifilm Corporation | 2019-04-25 |
| Brainlab Elements Image Fusion Angio (K190042) | Brainlab AG | 2019-04-25 |
| Ez3D-i/E3 (K190791) | Ewoosoft Co., Ltd. | 2019-04-19 |
| Lung Vision System (K183593) | Bodyvision Medical , Ltd. | 2019-04-18 |
| NDOHD High Definition Imaging System (NDOHD) (K190420) | Altaravision, Inc. | 2019-04-15 |
| InstaRISPACS / InstaZFP / InstaMobi v5.0 (K182572) | Meddiff Technologies Pvt. , Ltd. | 2019-04-12 |
| DBSWIN and VISTAEASY Imaging Software (K190629) | Durr Dental SE | 2019-04-01 |
| Thoracic VCAR with GSI Pulmonary Perfusion (K183210) | GE Medical Systems SCS | 2019-03-29 |
| Mimics Medical (K183105) | Materialise NV | 2019-03-27 |
| Synapse PACS (K190232) | Fujifilm Corporation | 2019-03-26 |
| uWS-MR (K183164) | Shanghai United Imaging Healthcare Co., Ltd. | 2019-03-22 |
| SIS Software version 3.3.0 (K183019) | Surgical Information Sciences, Inc. | 2019-03-19 |
| MIM on Linux (K190379) | Mim Software, Inc. | 2019-03-19 |
| RADMAX Digital Imaging Software (K182537) | DRGEM Corporation | 2019-03-08 |
| Visualase Thermal Therapy System (K181859) | Medtronic Navigation, Inc. | 2019-03-06 |
| PLANET Onco Dose (K182966) | Dosisoft | 2019-03-06 |
| ClearON Mobile (K183478) | Rayence Co., Ltd. | 2019-03-01 |
| EzDent-i / E2 / Prora View (K190087) | Ewoosoft Co., Ltd. | 2019-02-27 |
| IRIS 1.0 System (K182643) | Intuitive Surgical | 2019-02-22 |
| PhantomMSK (K182332) | OrthoGrid Systems, Inc. | 2019-02-15 |
| Presero 3D Scanning System (K190074) | Certis Health | 2019-02-14 |
| AI Rad Companion (Engine) (K183272) | Siemens Medical Solutions USA, Inc. | 2019-02-01 |
| MRCP+ v1.0 (K183133) | Perspectum Diagnostics, Ltd. | 2019-01-09 |
| ProKnow DS (K182855) | Proknow, LLC | 2019-01-02 |
| AmCAD-UO (K180867) | Amcad Biomed Corporation | 2018-12-28 |
| Quantib ND (K182564) | Quantib B.V. | 2018-12-27 |
| iSchemaView RAPID (K182130) | Ischemaview, Inc. | 2018-12-27 |
| 4D View (K182750) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2018-12-21 |
| vascuCAP (K183012) | Elucid Bioimaging, Inc. | 2018-12-21 |
| 3DIEMME RealGUIDE (K173041) | 3Diemme , Ltd. | 2018-12-20 |
| MIM - MRT Dosimetry (K182624) | Mim Software, Inc. | 2018-12-18 |
| Vitrea Software Package, VSTP-001A (K182601) | Canon Medical Systems Corporation | 2018-12-14 |
| Centricity Universal Viewer (K182419) | GE Healthcare | 2018-12-14 |
| HipCheck (K182359) | Stryker Corp. | 2018-12-13 |
| Simplicit90Y (K182016) | Mirada Medical, Ltd. | 2018-12-06 |
| IntelliSpace Radiology (K182926) | Philips Healthcare Informatics, Inc. | 2018-12-06 |
| CAAS MR Solutions (K181825) | Pie Medical Imaging BV | 2018-12-04 |
| IMPLANTER DENTAL PLANNING SOFTWARE (K173083) | Implanter, LLC | 2018-12-03 |
| XVWeb 3D (K182815) | Apteryx, Inc. | 2018-11-30 |
| Corin Optimized Positioning System (OPS) Plan (K183038) | Corin USA | 2018-11-26 |
| Vitrea Software Package, VSTP-001A (K183013) | Canon Medical Systems Corporation | 2018-11-26 |
| Konicaminolta DI-X1 (K182431) | Konica Minolta, Inc. | 2018-11-26 |
| ProFuse CAD (K173744) | Eigen | 2018-11-21 |
| Vitrea CT Brain Perfusion (K181247) | Vital Images, Inc. | 2018-11-20 |
| uWS-CT (K173001) | Shanghai United Imaging Healthcare Co., Ltd. | 2018-11-07 |
| uWS-MR (K172999) | Shanghai United Imaging Healthcare Co., Ltd. | 2018-11-07 |
| icobrain (K181939) | Icometrix NV | 2018-11-06 |
| AVIEW (K171199) | Coreline Soft Co., Ltd. | 2018-10-31 |
| Implant Planning Software (K173965) | Inteware Co., Ltd. | 2018-10-26 |
| PeekMed (K182464) | Peek Health, S.A. | 2018-10-25 |
| JiveX (K181964) | Visus Health IT GmbH | 2018-10-23 |
| UroNav (Version 3.0) (K182561) | Invivo Corporation | 2018-10-19 |
| Arterys MICA (K182034) | Arterys, Inc. | 2018-10-17 |
| OnePacs System (K181460) | Onepacs, LLC | 2018-10-11 |
| Ziostation2 (K181892) | Ziosoft, Inc. | 2018-10-09 |
| IBM iConnect Access (K182290) | Merge Healthcare Incorporated | 2018-09-25 |
| Synapse 3D Optional Tools (K181773) | Fujifilm Corporation | 2018-09-25 |
| iNtuition-T1 Mapping and T2/T2* Mapping (K180916) | Terarecon,Inc. | 2018-09-24 |
| InVivo Web Viewer (K181926) | Anatomage, Inc. | 2018-09-21 |
| Volpara Imaging Software (K182310) | Volpara Health Technologies Limited | 2018-09-21 |
| OpenSight (K172418) | Novarad Corporation | 2018-09-21 |
| syngo.via View&GO (Version VA10A) (K182208) | Siemens Healthcare GmbH | 2018-09-07 |
| Multi Modality Viewer (K182230) | Vital Images, Inc. | 2018-09-07 |
| mediCAD 4.0 (K170702) | Medicad Hectec GmbH | 2018-09-07 |
| AmCAD-UT Detection 2.2 (K180006) | Amcad Biomed Corporation | 2018-08-31 |
| Change Healthcare Enterprise Viewer (K181185) | Change Healthcare Canada Company | 2018-08-29 |
| IGTFusion (K180522) | Igi Technologies | 2018-08-16 |
| ONIS-PACS (K181318) | Digitalcore Co., Ltd. | 2018-08-13 |
| CubeVue (K181962) | Curvebeam, LLC | 2018-08-07 |
| VirtuOst Vertebral Fracture Assessment (K171435) | O.N. Diagnostics, LLC | 2018-08-03 |
| miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP Viewer (K171977) | Hinacom Software and Technology, Ltd. | 2018-08-02 |
| Quantitative Total Extensible Imaging (QTxI) (K173444) | Aiq Solutions, Inc. | 2018-07-23 |
| DentiqGuide (K180629) | 3D Industrial Imaging Co., Ltd. | 2018-07-19 |
| Ceevra Reveal 2.0 (K173274) | Ceevra, Inc. | 2018-07-10 |
| DenSeeMammo (K173574) | Statlife | 2018-06-26 |
| MIM - SPECTRA Quant (K180815) | Mim Software, Inc. | 2018-06-22 |
| sterEOS Workstation (K172346) | Eos Imaging | 2018-06-19 |
| Fusion Bx 2.0 (K181290) | Focal Healthcare, Inc. | 2018-06-15 |
| EchoMD Automated Ejection Fraction Software (K173780) | Bay Labs, Inc. | 2018-06-14 |
| QLAB Advanced Quantification Software (K181264) | Philips Ultrasound, Inc. | 2018-06-07 |
| Interventional Workspot (K181177) | Philips Medical Systems Nederland B.V. | 2018-05-31 |
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