Review Panel
Radiology FDA 510(k) Clearances & Devices
- Cleared Devices
- 14,721
- Product Codes (page)
- 26
- Latest Decision
- 2015-12-22
Clearances · page 46 of 148
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K152038 | MammoGRIP | Women'S Imaging Solutions Enterprises, LLC | IZH | Class II | 2015-12-22 |
| K151074 | Magnetic Reasonance Imaging System | Jiangsu Magspin Instrument Co.,Ltd | LNH | Class II | 2015-12-22 |
| K153318 | Philips Eleva Workspot with SkyFlow | Philips Medical Systems Dmc GmbH | MQB | Class II | 2015-12-22 |
| K153401 | GR40CW | Samsung Electronics Co., Ltd. | MQB | Class II | 2015-12-21 |
| K153085 | Q Series Diagnostic Ultrasound System | Chison Medical Imaging Co., Ltd. | IYN | Class II | 2015-12-21 |
| K153408 | HM70A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | 2015-12-21 |
| K151022 | Intraluminal Applicator Set | Varian Medical Systems, Inc. | JAQ | Class II | 2015-12-17 |
| K153480 | ClearVue850 Diagnostic Ultrasound System | Philips Health Care | IYN | Class II | 2015-12-16 |
| K152172 | Econsole1 | DRTECH Corporation | LLZ | Class II | 2015-12-14 |
| K152767 | OTC12D AUTO RADIOGRAPHIC SYSTEM | Del Medical, Inc. | KPR | Class II | 2015-12-14 |
| K152554 | Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT Technology | C.R. Bard, Inc. | IYO | Class II | 2015-12-14 |
| K152639 | DR 600 | Agfa Healthcare N.V. | MQB | Class II | 2015-12-11 |
| K153011 | iViewDose R1.0 | Elekta Limited | IYE | Class II | 2015-12-11 |
| K143514 | Panther StereoSeed | Prowess, Inc. | MUJ | Class II | 2015-12-11 |
| K150354 | PAPAYA 3D Plus | Genoray Co., Ltd. | OAS | Class II | 2015-12-10 |
| K152467 | Touch Ultrasound | Carestream Health, Inc. | IYN | Class II | 2015-12-09 |
| K152321 | kVue Encompass SRS Insert (Encompass Insert), Encompass SRS Standalone (Encompass Device), Encompass SRS MRI Immobilization device (Encompass MRI Device, Encompass Intracranial Fibreplast Variable Perf Head Only Open View System, Encompass Intracranial Fibreplast Variable Perf Head Only Open View with 119 mm opening | Qfix | IYE | Class II | 2015-12-04 |
| K152078 | Implant Studio 2015 | 3Shape Medical A/S | LLZ | Class II | 2015-12-04 |
| K151673 | Aquilion ONE Vision with FIRST 1.0 (CCRS-001A) | Toshibamedical Systems Corporation | JAK | Class II | 2015-11-27 |
| K152761 | Permanent Beacon Transponder, Soft Tissue Beacon Transponder, Beacon Care Package - Soft Tissue (17G) | Varian Medical Systems, Inc. | IYE | Class II | 2015-11-25 |
| K152785 | XIDF-AWS801, Angio Workstation, V6.20 | Toshibamedical Systems Corporation | OWB | Class II | 2015-11-25 |
| K152573 | 4Sight | Accutome, Inc. | IYO | Class II | 2015-11-25 |
| K151469 | CORVUS Radiation Therapy Planning System | Best Nomos | MUJ | Class II | 2015-11-25 |
| K152822 | VidiStar HeartView | Vidistar, LLC | LLZ | Class II | 2015-11-25 |
| K153142 | Carestream DRX-1 System with DRX Plus 4343 Detectors | Carestream Health, Inc. | MQB | Class II | 2015-11-25 |
| K142955 | SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATON Emotion 6/16, SOMATOM Sensation 64/Sensation Cardiac , SOMATOM Perspective SOMATOM Scope/ Scope Power | Siemens Medical Solutions USA, Inc. | JAK | Class II | 2015-11-24 |
| K142617 | ArcCHECK | Sun Nuclear Corporation | IYE | Class II | 2015-11-20 |
| K151414 | IQQA Guide | Edda Technology | JAK | Class II | 2015-11-20 |
| K152713 | 8MP Color LCD Monitor, RadiForce RX850, RX850-AR | Eizo Corporation | PGY | Class II | 2015-11-20 |
| K153101 | BladderScan Prime System | Verathon Incorporated | IYO | Class II | 2015-11-19 |
| K153022 | Philips IntelliSpace Cardiovascular | Philips Medical Systems Nethrlands BV | LLZ | Class II | 2015-11-18 |
| K152758 | Venue 50 | GE Medical Systems Ultrasound and Primary Care Diagnostics | IYN | Class II | 2015-11-18 |
| K152695 | 8 CH Knee SPEEDER | Quality Electrodynamics, LLC | MOS | Class II | 2015-11-18 |
| K152847 | DIVA ZSP5812CMI with QUBYX PerfectLum bundle | Qubyx , Ltd. | PGY | Class II | 2015-11-17 |
| K152318 | MD-2300S Ultrasonic A/B Scanner for Ophthalmology | MEDA Co., Ltd. | IYO | Class II | 2015-11-17 |
| K153073 | UroNav (Version 2.0) | Invivo Corporation | LLZ | Class II | 2015-11-16 |
| K150504 | GUS ASTRA TEE Transesophageal Probe Reprocessor, GUS ASTRA VR Endovaginal/Endorectal Probe Reprocessor | Pci Medical, Inc. | PSW | Class II | 2015-11-16 |
| K152661 | HICAT Air | Hicat GmbH | LLZ | Class II | 2015-11-16 |
| K152928 | Multitom Rax | Siemens Medical Solutions USA, Inc. | OWB | Class II | 2015-11-13 |
| K151752 | SOMATOM Emotion 6/16 | Siemens Medical Solutions USA, Inc. | JAK | Class II | 2015-11-12 |
| K152983 | FUJIFILM SonoSite iViz Ultrasound System | FUJIFILM Sonosite, Inc. | IYN | Class II | 2015-11-12 |
| K152151 | ATAL 9 | Atlaim Corporation | MQB | Class II | 2015-11-10 |
| K153058 | CareView 1500C/ CareView 1500L X-ray Flat Panel Detectors | Careray Digital Medical System Co., Ltd. | MQB | Class II | 2015-11-10 |
| K151946 | Thermofit | Orfit Industries | IYE | Class II | 2015-11-09 |
| K152567 | Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound System | GE Healthcare | IYN | Class II | 2015-11-06 |
| K151376 | superDimension Navigation System | Covidien, LLC | JAK | Class II | 2015-11-05 |
| K152138 | FDR D-EVO GL Flat Panel Detector System | Fujifilm Medical System U.S.A., Inc. | MQB | Class II | 2015-11-05 |
| K151212 | Ziostation2 | Qi Imaging, LLC | LLZ | Class II | 2015-11-04 |
| K151383 | NeuViz 128 Multi-slice CT Scanner System | Neusoft Medical Systems Co., Ltd. | JAK | Class II | 2015-11-04 |
| K152962 | HS70A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | 2015-11-02 |
| K151403 | Positron Emission Tomography (PET) and Computed Tomography (CT) System, Positron Emission Tomography (PET) and Computed Tomography (CT) System | Neusoft Medical Systems Co., Ltd. | KPS | Class II | 2015-11-02 |
| K150713 | syngo.CT Myocardial Perfusion | Siemens Medical Solutions USA, Inc. | JAK | Class II | 2015-11-02 |
| K152592 | PROBEAT-V | Hitachi, Ltd., Health Care Company | LHN | Class II | 2015-11-02 |
| K150595 | SCENARIA Phase 3 Whole-body X-ray CT System | Hitachi Medical Systems America, Inc. | JAK | Class II | 2015-10-30 |
| K151283 | Lung Analysis Software | Vital Images, Inc. | JAK | Class II | 2015-10-30 |
| K152899 | Philips Lumify Diagnostic Ultrasound System | Philips Healthcare, Inc. | IYN | Class II | 2015-10-30 |
| K151159 | Leksell Gamma Knife Perfexion | Elekta Instrument AB | IWB | Class II | 2015-10-29 |
| K152120 | OPTIS Mobile System | Lightlab Imaging, Inc. | NQQ | Class II | 2015-10-29 |
| K152543 | M9/M9CV/M9T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | Class II | 2015-10-29 |
| K153003 | SIGNA Pioneer | GE Healthcare | LNH | Class II | 2015-10-27 |
| K151882 | Varian Treatment (VTx) | Varian Medical Systems, Inc. | IYE | Class II | 2015-10-26 |
| K152028 | Volpara Imaging Software | Matakina Technologies Limited | LLZ | Class II | 2015-10-26 |
| K152106 | Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D Smart | VATECH Co., Ltd. | OAS | Class II | 2015-10-23 |
| K152371 | Vantage Titan 3T | Toshibamedical Systems Corporation | LNH | Class II | 2015-10-23 |
| K152763 | Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | Class II | 2015-10-21 |
| K151942 | EVS 3643 | DRTECH Corporation | MQB | Class II | 2015-10-21 |
| K152788 | EOS System | Eos Imaging | KPR | Class II | 2015-10-21 |
| K152867 | MHI-TM2000 Linear Accelerator System, VERO, Imavis | Mitsubishi Heavy Industries, Ltd. | IYE | Class II | 2015-10-21 |
| K152094 | GR40CW | Samsung Electronics Co., Ltd. | MQB | Class II | 2015-10-16 |
| K150037 | Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities | Sensus Healthcare | JAD | Class II | 2015-10-16 |
| K151988 | Visible Patient Suite | Visible Patient, Sas | LLZ | Class II | 2015-10-15 |
| K151466 | MrOpen | Paramed S.R.L. | LNH | Class II | 2015-10-15 |
| K151919 | Vitrea CT Lung Density Analysis Software | Vital Images, Inc. | JAK | Class II | 2015-10-10 |
| K150306 | D2RS_AT Digital Dynamic Remote System | Stephanix Radiological Solutions | JAA | Class II | 2015-10-10 |
| K151833 | Aquilion Lightning (TSX-035A/2, V7.0) | Toshibamedical Systems Corporation | JAK | Class II | 2015-10-09 |
| K152036 | SOMATOM Definition Edge, SOMATOM Definition AS/AS+ | Siemens Medical Solutions USA, Inc. | JAK | Class II | 2015-10-09 |
| K152577 | ULTRASOUND SYSTEM SONIMAGE HS 1 | Konica Minolta, Inc. | IYN | Class II | 2015-10-08 |
| K151941 | DEXIS Webview | Imaging Sciences International /Gendex/Dexis | LLZ | Class II | 2015-10-07 |
| K152369 | ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond System | Siemens Medical Solutions USA, Inc. Ultrasound Group | IYN | Class II | 2015-10-06 |
| K143560 | CygneX I System | Accuthera, Inc. | IYE | Class II | 2015-10-05 |
| K151910 | Ultrasound Scanner System BK2300 | Bk Medical Aps | IYN | Class II | 2015-10-05 |
| K143494 | ADX6000 Portable X-Ray System; iRayA6 | Dexcowin Co., Ltd. | IZL | Class II | 2015-10-05 |
| K151501 | OrthoVis Web Portal | Custom Orthopaedic Solutions, Inc. | LLZ | Class II | 2015-10-02 |
| K152545 | DC-60/DC-60S/DC-60 EXP/DC-55 Diagnostic Ultrasound Systems | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | Class II | 2015-10-02 |
| K152207 | Extended Range Shifter for PROBEAT-V | Hitachi, Ltd., Health Care Company | LHN | Class II | 2015-10-02 |
| K151952 | Synergy ODM | Topcon Medical Systems, Inc. | NFJ | Class II | 2015-10-01 |
| K151280 | MultiScan G-Arm System | Beijing East Whale Imaging Technology Co., Ltd. | OXO | Class II | 2015-09-30 |
| K150565 | Supria Whole-body X-ray CT System | Hitachi Medical Systems America, Inc. | JAK | Class II | 2015-09-30 |
| K152195 | LOGIQ S8 | GE Healthcare | IYN | Class II | 2015-09-29 |
| K151579 | MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma, MAGNETOM Prisma fit | Siemens Medical Solutions USA, Inc. | LNH | Class II | 2015-09-29 |
| K152488 | Onrad Treatment System | Accuray Incorporated | MUJ | Class II | 2015-09-28 |
| K152403 | Permanent Sled Bag | Boston Scientific | ITX | Class II | 2015-09-22 |
| K152469 | ACUSON NX3 Elite / NX3 Diagnostic Ultrasound System | Siemens Medical Solutions, Inc., Ultrasound Division | IYN | Class II | 2015-09-21 |
| K151774 | CARESTREAM Vue Motion | Carestream Health, Inc. | LLZ | Class II | 2015-09-21 |
| K152393 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | MUJ | Class II | 2015-09-18 |
| K152316 | iLab Ultrasound Imaging System | Boston Scientific | IYO | Class II | 2015-09-18 |
| K150382 | Radio Therapy Treatment Chair | Radiation Products Design, Inc. | IYE | Class II | 2015-09-16 |
| K152030 | Hisense 2MP/3MP LCD Monitor (HMD2C21/HMD3C21) | Qingdao Hisense Medical Equipment Co., Ltd. | PGY | Class II | 2015-09-16 |
| K152052 | Ultrasound Scanner System bk2300 | Bk Medical Aps | IYN | Class II | 2015-09-16 |
| K151887 | syngo VSim | Siemens Medical Solutions USA, Inc. | MUJ | Class II | 2015-09-16 |
14,721 clearances in the Radiology panel. Data: openFDA.