Radiology
14,649 FDA 510(k) clearances · Medical specialty
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| Record | Firm | Date |
|---|---|---|
| MAGNETOM Amira, MAGNETOM Sempra (K183221) | Siemens Medical Solutions USA, Inc. | 2019-02-14 |
| MyoStrain 5.1 (K182756) | Myocardial Solutions | 2019-02-14 |
| Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems (K183063) | Philips Medical Systems Nederland B.V. | 2019-02-14 |
| Presero 3D Scanning System (K190074) | Certis Health | 2019-02-14 |
| SnapShot Freeze 2 (K183161) | Ge Medical Systems, LLC | 2019-02-13 |
| KOWA VK-2s (K190056) | Kowa Co. Ltd. Chofu | 2019-02-12 |
| Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil – 4, Infant Coil – 24, Cardiac Coil – 24, Foot & Ankle Coil - 24 (K183186) | Shanghai United Imaging Healthcare Co., Ltd. | 2019-02-08 |
| Carestream DRX-1 System with DRX Plus 2530 Detectors (K183245) | Carestream Health, Inc. | 2019-02-08 |
| SonoSite SII Ultrasound System (K183235) | FUJIFILM Sonosite, Inc. | 2019-02-07 |
| JADE Mobile X-Ray (K183388) | DRGEM Corporation | 2019-02-05 |
| JUSHA-C270G/ JUSHA-C270/ C270G/ C270 LCD Monitor (K183498) | Nanjing Jusha Display Technology Co., Ltd. | 2019-02-05 |
| JUSHA-M350G/JUSHA-M350/M350G/M350 LCD Monitor (K183499) | Nanjing Jusha Display Technology Co., Ltd. | 2019-02-04 |
| AI Rad Companion (Engine) (K183272) | Siemens Medical Solutions USA, Inc. | 2019-02-01 |
| Supria True64 Whole-Body X-Ray CT System (K183291) | Hitachi Healthcare Americas | 2019-02-01 |
| DR 800 with Tomosynthesis (K183275) | Agfa N.V. | 2019-02-01 |
| X5 Series Digital Color Doppler Ultrasound System (K182648) | Sonoscape Medical Corp. | 2019-01-29 |
| Venue GO (K183362) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2019-01-28 |
| Aloka Arietta 850 (K183456) | Hitachi Healthcare Americas | 2019-01-28 |
| MAGNETOM Lumina (K183244) | Siemens Medical Solutions USA, Inc. | 2019-01-24 |
| ProRad 2FC and ProRad 3NC Stationary Radiographic Systems (K183541) | Prognosys Medical Systems Private Limited | 2019-01-24 |
| E-CUBE i7 (K182594) | Alpinion Medical Systems Co., Ltd. | 2019-01-24 |
| SPY Elite Intraoperative Perfusion Assessment System (K182907) | Novadaq Technologies Ulc. (Now A Part of Stryker) | 2019-01-23 |
| O-Scan (K183685) | Esaote, S.p.A. | 2019-01-22 |
| HM70A Diagnostic Ultrasound System (K182894) | Samsung Medison Co., Ltd. | 2019-01-22 |
| Magnetom Vida (K183254) | Siemens Medical Solutions USA, Inc. | 2019-01-18 |
| SIGNA Premier (K183231) | Ge Medical Systems, LLC | 2019-01-18 |
| Pristina Serena 3D (K182951) | GE Healthcare | 2019-01-18 |
| Carestream DRX-1 System with DRX Core Detectors (K183474) | Carestream Health, Inc. | 2019-01-16 |
| JUSHA-M260G LCD Monitor, JUSHA-M260 LCD Monitor, M260G LCD Monitor, M260 LCD Monitor (K183497) | Nanjing Jusha Display Technology Co., Ltd. | 2019-01-15 |
| uMR 580, uMR 588 (K183137) | Shanghai United Imaging Healthcare Co., Ltd. | 2019-01-11 |
| MULTIX Impact (K182517) | Siemens Medi Cal Solutions, Inc. | 2019-01-11 |
| DigitalDiagnost C90 (K182973) | Philips Medical Systems Dmc GmbH | 2019-01-11 |
| DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System (K182636) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2019-01-10 |
| Trident HD Specimen Radiography System (K182727) | Hologic, Inc. | 2019-01-10 |
| Wireless Digital Flat Panel Detector (K183422) | Iray Technology Taicang , Ltd. | 2019-01-09 |
| Wireless Digital Flat Detector (K183713) | Iray Technology Taicang , Ltd. | 2019-01-09 |
| MRCP+ v1.0 (K183133) | Perspectum Diagnostics, Ltd. | 2019-01-09 |
| DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System (K181637) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2019-01-09 |
| HS30 Diagnostic Ultrasound System (K182632) | Samsung Medison Co., Ltd. | 2019-01-08 |
| uCT 520, uCT 528 (K183143) | Shangai United Imaging Healthcare Co., Ltd. | 2019-01-03 |
| ProKnow DS (K182855) | Proknow, LLC | 2019-01-02 |
| Zenition 50 (K183101) | Philips Medical Systems Nederland B.V. | 2018-12-31 |
| AmCAD-UO (K180867) | Amcad Biomed Corporation | 2018-12-28 |
| minisono (K182845) | Alpinion Medical Systems Co., Ltd. | 2018-12-27 |
| 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 |
| Color Doppler Ultrasound System; Model: mEye1 and mEye2 (K182165) | Shenzhen Well.D Medical Electronics Co., Ltd. | 2018-12-20 |
| 3DIEMME RealGUIDE (K173041) | 3Diemme , Ltd. | 2018-12-20 |
| HERA W10 Diagnostic Ultrasound System (K182595) | Samsung Medison Co., Ltd. | 2018-12-18 |
| MIM - MRT Dosimetry (K182624) | Mim Software, Inc. | 2018-12-18 |
| Emission Computed Tomography System (K182938) | Shanghai United Imaging Healthcare Co., Ltd. | 2018-12-18 |
| SKR 3000 (K182688) | Konica Minolta, Inc. | 2018-12-18 |
| Vitrea Software Package, VSTP-001A (K182601) | Canon Medical Systems Corporation | 2018-12-14 |
| RCT800 (K182805) | Ray Co., Ltd. | 2018-12-14 |
| TR90BH (K182207) | Minxray, Inc. | 2018-12-14 |
| Centricity Universal Viewer (K182419) | GE Healthcare | 2018-12-14 |
| HipCheck (K182359) | Stryker Corp. | 2018-12-13 |
| X-ray Imaging System for the McLaren Proton Treatment System (K181498) | Ehmetdx, LLC | 2018-12-10 |
| 17HK701G-W (K183286) | Lg Electronics.Inc | 2018-12-07 |
| GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85A (K182183) | Samsung Electronics Co., Ltd. | 2018-12-07 |
| Contour 24 (K183111) | Quality Electrodynamics, LLC | 2018-12-07 |
| Nexus DR Digital X-ray Imaging System with stitching (K183212) | Varex Imaging Corporation | 2018-12-07 |
| PowerLook Tomo Detection V2 Software (K182373) | Icad, Inc. | 2018-12-06 |
| AMRA Profiler (K173749) | Amra Medical AB | 2018-12-06 |
| Simplicit90Y (K182016) | Mirada Medical, Ltd. | 2018-12-06 |
| IntelliSpace Radiology (K182926) | Philips Healthcare Informatics, Inc. | 2018-12-06 |
| Zenition 70 (K183040) | Philips Medical Systems Nederland B.V. | 2018-12-06 |
| Vivid iq (K181727) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2018-12-06 |
| MOSAIQ Oncology Information System (K183034) | Elekta, Inc. | 2018-12-04 |
| 6420 Ultrasound System (K183191) | Esaote, S.p.A. | 2018-12-04 |
| Monaco RTP System (K183037) | Elekta, Inc. | 2018-12-04 |
| Elekta Unity (K182076) | Elekta Limited | 2018-12-04 |
| CAAS MR Solutions (K181825) | Pie Medical Imaging BV | 2018-12-04 |
| HS50 / HS60 Diagnostic Ultrasound System (K181336) | Samsung Medison Co., Ltd. | 2018-12-04 |
| IMPLANTER DENTAL PLANNING SOFTWARE (K173083) | Implanter, LLC | 2018-12-03 |
| SubtlePET (K182336) | Subtle Medical, Inc. | 2018-11-30 |
| Planmed Verity (K180918) | Planmed OY | 2018-11-30 |
| FerriSmart Analysis System (K182218) | Resonance Health Analysis Services Pty, Ltd. | 2018-11-30 |
| XVWeb 3D (K182815) | Apteryx, Inc. | 2018-11-30 |
| ARiX RAD Radiographic System (K182134) | Compania Mexicana DE Radiologia Cgr, S.A. DE C.V. | 2018-11-26 |
| 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 |
| Motion Tracking and Compensation Feature for the Radixact Treatment Delivery System (K182687) | Accuray Incorporated | 2018-11-23 |
| Transpara (K181704) | Screenpoint Medical B.V. | 2018-11-21 |
| Versana Premier (K182277) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2018-11-21 |
| ProFuse CAD (K173744) | Eigen | 2018-11-21 |
| 6MP Color LCD Monitor (C61W+) (K182291) | Shenzhen Beacon Display Technology Co., Ltd. | 2018-11-20 |
| Vitrea CT Brain Perfusion (K181247) | Vital Images, Inc. | 2018-11-20 |
| Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound System (K182715) | Shenzhen Wisonic Medical Technology Co. , Ltd. | 2018-11-20 |
| Celesteion, PCA-9000A/3, V6.5 (K181646) | Canon Medical Systems Corporation | 2018-11-16 |
| OEC One (K182626) | Ge Hualun Medical Systems Co. , Ltd. | 2018-11-16 |
| 1.5T 16ch Breast Coil (K182958) | Neocoil, LLC | 2018-11-16 |
| 1.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil (K181948) | Rapid Biomedical GmbH | 2018-11-16 |
| Voluson E6, Voluson E8, Voluson E10 (K181985) | GE Healthcare | 2018-11-15 |
| Z6 Diagnostic Ultrasound System (K182603) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2018-11-14 |
| RectalPro 75 Endorectal Balloon (K180478) | Qlrad International , Ltd. | 2018-11-13 |
| VERITON CT whole body SPECT/CT system (K182484) | Spectrum Dynamics Medical, Ltd. | 2018-11-09 |
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Every clearance here is in the API, with alerts when new ones post.