Review Panel
Radiology FDA 510(k) Clearances & Devices
- Cleared Devices
- 14,721
- Product Codes (page)
- 25
- Latest Decision
- 2016-07-29
Clearances · page 44 of 148
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K161839 | 2D Quantitative Analysis | Philips Medical Systems Nederland B.V. | OWB | Class II | 2016-07-29 |
| K161563 | Allura Xper FD series and Allura Xper OR Table series | Philips Medical Systems Nederland B.V. | OWB | Class II | 2016-07-29 |
| K161787 | ACUSON NX2 Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc. | IYN | Class II | 2016-07-28 |
| K160935 | 8ch Foot Ankle Coil | Shenzhen RF Tech Co., Ltd. | MOS | Class II | 2016-07-28 |
| K161631 | MAMMI | General Equipment For Medical Imaging | KPS | Class II | 2016-07-28 |
| K161118 | SIMPLANT Online Case Review and SIMPLANT Editor | Dentsply Sirona | LLZ | Class II | 2016-07-28 |
| K161382 | LVivo Software Application | Diacardio, Ltd. | LLZ | Class II | 2016-07-28 |
| K161009 | Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4 | Toshibamedical Systems Corporation | JAK | Class II | 2016-07-22 |
| K160984 | MultiScan G-Arm System | Beijing East Whale Imaging Technology Co., Ltd. | OXO | Class II | 2016-07-20 |
| K161359 | 6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System | Esaote, S.p.A. | IYN | Class II | 2016-07-19 |
| K152294 | FDR Visionary Suite | Shimadzu Corporation | KPR | Class II | 2016-07-15 |
| K161920 | Comfort Cover | Precision Dynamics Corporation | IZH | Class II | 2016-07-15 |
| K160518 | LEONI ORION System | Leoni Cia Cable System | JAI | Class II | 2016-07-14 |
| K161163 | PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory | Hitachi , Ltd. | LHN | Class II | 2016-07-13 |
| K161525 | TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | Class II | 2016-07-13 |
| K161419 | Multi Modality Viewer | Vital Images, Inc. | LLZ | Class II | 2016-07-13 |
| K161685 | syngo®.via protoNeo (Version VA10A) | Siemens Healthcare GmbH | LLZ | Class II | 2016-07-11 |
| K161238 | S-scan | Esaote, S.p.A. | LNH | Class II | 2016-07-08 |
| K160088 | Cydar EV | Cydar , Ltd. | OWB | Class II | 2016-07-07 |
| K161345 | RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR | Sedecal., Sa. | IZL | Class II | 2016-07-06 |
| K160997 | GC85A | Samsung Electronics Co., Ltd. | KPR | Class II | 2016-07-06 |
| K161395 | SPEC Model M13 | Source Production and Equipment Co., Inc. | KXK | Class II | 2016-07-06 |
| K153740 | RTHawk, HeartVista Cardiac Package | Heartvista, Inc. | LNH | Class II | 2016-06-30 |
| K161285 | Ablation Confirmation | Neuwave Medical, Inc. | JAK | Class II | 2016-06-29 |
| K153360 | ADMIRE | Siemens Medi Cal Solutions, Inc. | JAK | Class II | 2016-06-29 |
| K160878 | OPTIS Metallic Stent Optimization E.4 SW | Lightlab Imaging, Inc. | NQQ | Class II | 2016-06-29 |
| K153312 | SCATTER CORRECTION FOR CXDI SERIES | Canon, Inc. | MQB | Class II | 2016-06-28 |
| K161479 | hipEOS | Onefit Medical | LLZ | Class II | 2016-06-28 |
| K160584 | Surgical Navigation Advanced Platform (SNAP) | Surgical Theater, LLC | LLZ | Class II | 2016-06-28 |
| K160853 | Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging System | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) | IYN | Class II | 2016-06-27 |
| K161146 | Radixact Treatment Delivery System | Accuray Incorporated | IYE | Class II | 2016-06-24 |
| K161136 | Precision Treatment Planning System | Accuray Incorporated | MUJ | Class II | 2016-06-24 |
| K161144 | iDMS Data Management System | Accuray Incorporated | IYE | Class II | 2016-06-24 |
| K161559 | Kuvia3D | 4qimaging, LLC Dba Qmetrics | LLZ | Class II | 2016-06-23 |
| K161061 | IMPAX Volume Viewing 4.0 | Agfa Healthcare N.V. | LLZ | Class II | 2016-06-22 |
| K160334 | Advanced Medical Imaging Software Suite (KSWVWR) | Keosys Sas | LLZ | Class II | 2016-06-21 |
| K160209 | Gold Anchor | Naslund Medical AB | IYE | Class II | 2016-06-21 |
| K161444 | DBSWIN and VistaEasy Imaging Software | Duerr Dental AG | LLZ | Class II | 2016-06-21 |
| K160131 | OEC Elite MiniView | Ge Hangwei Medical Systems Co., Ltd. | OXO | Class II | 2016-06-21 |
| K160525 | RCT700 | Ray Co., Ltd. | OAS | Class II | 2016-06-20 |
| K152244 | RADspeed Pro | Shimadzu Corporation | KPR | Class II | 2016-06-20 |
| K153351 | Quantib Brain 1 | Quantib B.V. | LLZ | Class II | 2016-06-17 |
| K160350 | ECG CT Gating Device | Neocoil, LLC | JAK | Class II | 2016-06-16 |
| K161342 | Sonic Window | Analogic Corporation | IYO | Class II | 2016-06-15 |
| K160627 | Symphony Patient Transport System, Symphony Patient Trolley, Symphony Standard Transfer Surface, Symphony Portrait (Head/Neck) Transfer Surface, Symphony Brachytherapy solution | Qfix | IYE | Class II | 2016-06-14 |
| K160618 | Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T | Ge Medical Systems, LLC | LNH | Class II | 2016-06-09 |
| K161188 | HEPATIQ 1.1 | Hepatiq, LLC | LLZ | Class II | 2016-06-09 |
| K160587 | Aquilion ONE (TSX-305A/3) V7.3 | Toshibamedical Systems Corporation | JAK | Class II | 2016-06-09 |
| K160204 | BSD4343 Digital Flat Panel X-ray Detector | Bontech, Inc. | MQB | Class II | 2016-06-09 |
| K151137 | X-VIEW, IMAGEN | Edlen Imaging, LLC | OAS | Class II | 2016-06-07 |
| K161193 | 16ch Tx/Rx Knee SPEEDER | Quality Electrodynamics, LLC | MOS | Class II | 2016-06-02 |
| K153056 | Hermes Medical Imaging Suite v5.6 | Hermes Medical Solutions AB | KPS | Class II | 2016-06-01 |
| K150979 | CT/MR Compatible M.A.C. Interstitial GYN Template | Mick Radio-Nuclear Instruments, Inc. | JAQ | Class II | 2016-05-31 |
| K161300 | Acclarix AX8 Diagnostic Ultrasound System | Edan Instruments, Inc. | IYO | Class II | 2016-05-31 |
| K161246 | Ez3D-i / E3 | Ewoosoft Co., Ltd. | LLZ | Class II | 2016-05-31 |
| K153736 | 3mensio Workstation | Pie Medical Imaging BV | LLZ | Class II | 2016-05-27 |
| K153026 | Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt, Rail Clamp for Respiratory Belt, Pressure Gauge Replacement | Medtec, Inc. D/B/A Civco Medical Solutions | IYE | Class II | 2016-05-25 |
| K160065 | GEMSS Medical System Surgical Mobile Fluoroscopic X-ray System | Gemss Medical Systems Co., Ltd. | OXO | Class II | 2016-05-20 |
| K160810 | ViZion DR + Wireless | Viztek, LLC | MQB | Class II | 2016-05-20 |
| K160152 | Trillium Oval V 5.1 MRI System | Hitachi Medical Systems America, Inc. | LNH | Class II | 2016-05-20 |
| K160506 | Planmeca ProMax 3D Max, Planmeca Maximity | Planmeca Oy | OAS | Class II | 2016-05-20 |
| K161229 | Mammo Tomosynthesis (MDMG-5221) | Barco N.V. | PGY | Class II | 2016-05-18 |
| K153331 | SafeCT-29 | Medic Vision Imaging Solutions | JAK | Class II | 2016-05-17 |
| K161117 | EzDent-i / E2 / Prora View | Ewoosoft Co., Ltd. | LLZ | Class II | 2016-05-13 |
| K161119 | SonoSite iViz Ultrasound System | FUJIFILM Sonosite, Inc. | IYN | Class II | 2016-05-13 |
| K160240 | Perimeter Otis 1.0 Optical Coherence Tomography System | Perimeter Medical Imaging, Inc. | NQQ | Class II | 2016-05-13 |
| K152020 | Bindex BI-100 | Bone Index Finland , Ltd. | MUA | Class II | 2016-05-13 |
| K161057 | Diagnostic Imaging Color LCD Monitor | Nec Display Solutions , Ltd. | PGY | Class II | 2016-05-13 |
| K160057 | ArcCHECK-MR | Sun Nuclear Corporation | IYE | Class II | 2016-05-13 |
| K153620 | Enovare Ultrasound System | Oreon Technologies, Inc. | IYO | Class II | 2016-05-05 |
| K161047 | LOGIQ P9 and LOGIQ P7 | GE Healthcare | IYN | Class II | 2016-05-05 |
| K153277 | 6200 Ultrasound System and 6250 Ultrasound System | Esaote, S.p.A. | IYN | Class II | 2016-05-04 |
| K160357 | TRINITY | Koelis | IYN | Class II | 2016-05-02 |
| K160354 | MX50T(MX50TQS) | Wide Corporation | PGY | Class II | 2016-05-02 |
| K152299 | TBS iNsight | Medimaps Group SA | KGI | Class II | 2016-04-29 |
| K153014 | Mobius3D | Mobius Medical Systems, LP | IYE | Class II | 2016-04-29 |
| K160162 | Voluson P6, Voluson P8 | GE Healthcare | IYN | Class II | 2016-04-26 |
| K151913 | MIM-Thin Client (mobile) | Mim Software, Inc. | LLZ | Class II | 2016-04-25 |
| K160914 | sterEOS Workstation | Eos Imaging, Inc. | LLZ | Class II | 2016-04-22 |
| K160353 | MX50N(MX50YQS) | Wide Corporation | PGY | Class II | 2016-04-22 |
| K160432 | Anzai Respiratory Gating System | Anzai Medical Co., Ltd. | LHN | Class II | 2016-04-22 |
| K153614 | PROBEAT-V and accessories | Hitachi, Ltd., Health Care Company | LHN | Class II | 2016-04-21 |
| K160440 | Leksell Gamma Knife Icon | Elekta Instrument AB | IWB | Class II | 2016-04-20 |
| K160674 | Fujifilm Sonosite Vevo MD Imaging System | FUJIFILM Sonosite, Inc. | IYN | Class II | 2016-04-19 |
| K160126 | AIRO Computed Tomography (CT) X-ray System | Mobius Imaging | JAK | Class II | 2016-04-19 |
| K153343 | MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fit | Siemens Medi Cal Solutions, Inc. | LNH | Class II | 2016-04-15 |
| K160792 | Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder Ultrasound | The Prometheus Group | IYO | Class II | 2016-04-15 |
| K160348 | CX30N (CX30PQX) | Wide Corporation | PGY | Class II | 2016-04-14 |
| K160346 | MX30N(MX30TQS) | Wide Corporation | PGY | Class II | 2016-04-14 |
| K160021 | Varian Sterilization Boxes | Varian Medical Systems, Inc. | JAQ | Class II | 2016-04-13 |
| K153653 | DICOM Viewer | Brainlab AG | LLZ | Class II | 2016-04-13 |
| K160376 | EndoSize | Therenva Sas | LLZ | Class II | 2016-04-12 |
| K160407 | spineEOS | Onefit Medical | LLZ | Class II | 2016-04-08 |
| K153444 | Philips Multislice CT System with Low Dose CT Lung Cancer | Philips Medical Systems (Cleveland), Inc. | JAK | Class II | 2016-04-08 |
| K153581 | Bladder Scanner | Caresono Technology Co., Ltd. | IYO | Class II | 2016-04-08 |
| K160093 | RayStation | RaySearch Laboratories AB (PUBL) | MUJ | Class II | 2016-04-08 |
| K153464 | FDR D-EVO flat Panel Detector System | Fujifilm Medical Systems U.S.A, Inc. | MQB | Class II | 2016-04-08 |
| K160579 | Xmaru View V1 and Xmaru PACS, Medical Image Processing Software | Rayence Co., Ltd. | LLZ | Class II | 2016-04-08 |
| K160343 | SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner | Beijing East Whale Imaging Technology Co., Ltd. | IYN | Class II | 2016-04-07 |
| K160355 | CX20N(CX20PUX) | Wide Corporation | PGY | Class II | 2016-04-07 |
14,721 clearances in the Radiology panel. Data: openFDA.