Review Panel
Radiology FDA 510(k) Clearances & Devices
- Cleared Devices
- 14,721
- Product Codes (page)
- 19
- Latest Decision
- 2018-04-12
Clearances · page 37 of 148
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K180549 | ZED Link | Zed Technologies | LLZ | Class II | 2018-04-12 |
| K180318 | PET Digital Gating | Ge Medical Systems, LLC | KPS | Class II | 2018-04-11 |
| K173860 | s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound Imaging and Pressure Systems, CORE Precision Guided Therapy System, CORE Mobile Precision Guided Therapy System | Volcano Corporation | IYO | Class II | 2018-04-11 |
| K170570 | Anchored Beacon(R) transponder, Anchored transponder, Beacon Care Package - Lung | Varian Medical Systems, Inc. | IYE | Class II | 2018-04-06 |
| K171847 | Corin Optimized Positioning System (OPS) Plan | Corin U.S.A. Limited | LLZ | Class II | 2018-04-05 |
| K173897 | syngo.via MI Workflows | Siemens Medical Solutions USA, Inc. | LLZ | Class II | 2018-04-05 |
| K180125 | PowerLook Density Assessment Software | Icad, Inc. | LLZ | Class II | 2018-04-05 |
| K180589 | DR 800 with MUSICA Dynamic | Agfa Healthcare N.V. | JAA | Class II | 2018-04-05 |
| K172998 | uWS-MI | Shanghai United Imaging Healthcare Co., Ltd. | LLZ | Class II | 2018-04-05 |
| K173597 | Scenium VE20 Software | Siemens Medical Solutions USA, Inc. | LLZ | Class II | 2018-04-04 |
| K172239 | SIMPLANT 18 | Dentsply Sirona | LLZ | Class II | 2018-04-04 |
| K173079 | Ingenia 1.5T, Ingenia 1 5T S, Ingenia 1.5T CX, Ingenia 3.0T CX R5.4 | Philips Medical Systems Nederland B.V. | LNH | Class II | 2018-04-04 |
| K180571 | GammaPod | Xcision Medical Systems, LLC | IWB | Class II | 2018-04-04 |
| K180595 | SciMoCa | Radialogica, LLC | IYE | Class II | 2018-04-04 |
| K180586 | Varian Head Frame | Varian Medical Systems, Inc. | IYE | Class II | 2018-04-02 |
| K173639 | Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax | Siemens Medi Cal Solutions, Inc. | OWB | Class II | 2018-04-02 |
| K173617 | MAGNETOM Vida with Compressed Sensing GRASP-VIBE | Siemens Medical Solutions USA, Inc. | LNH | Class II | 2018-03-30 |
| K173637 | syngo.CT Coronary Analysis; syngo.CT Vascular Analysis | Siemens Medical Solutions USA, Inc. | JAK | Class II | 2018-03-30 |
| K173789 | Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon | Elekta Instrument AB | IWB | Class II | 2018-03-30 |
| K173517 | RADspeed fit | Shimadzu Corporation | KPR | Class II | 2018-03-30 |
| K173630 | SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Deinition AS/AS+, SOMATOM Confidence | Siemens Medical Solutions USA, Inc. | JAK | Class II | 2018-03-30 |
| K180323 | Vitrea Software Package; VSTP-001A | Canon Medical Systems Corporation | LLZ | Class II | 2018-03-30 |
| K180592 | G-scan Brio | Esaote, S.p.A. | LNH | Class II | 2018-03-30 |
| K180535 | Voluson P6 and Voluson P8 | GE Healthcare | IYN | Class II | 2018-03-29 |
| K180308 | Prelude | Medcom GmbH | MUJ | Class II | 2018-03-27 |
| K173425 | SRT-100+ | Sensus Healthcare, Inc. | JAD | Class II | 2018-03-23 |
| K173241 | MED-TAB | Plum Medical Solutions GmbH | LLZ | Class II | 2018-03-23 |
| K180473 | ANYVIEW DR SERIES FPD Fluoroscopic Mobile C-arm ANYVIEW-240DR, ANYVIEW-320DR, ANYVIEW-500DR | Ecotron Co., Ltd. | OWB | Class II | 2018-03-23 |
| K163661 | P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil | Rapid Biomedical GmbH | MOS | Class II | 2018-03-21 |
| K172611 | Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Sets, odd lengths and even lengths, Universal Titanium Cervix Probe Sets, odd lengths and even lengths | Varian Medical Systems, Inc. | JAQ | Class II | 2018-03-21 |
| K173619 | Mimics inPrint | Materialise NV | LLZ | Class II | 2018-03-21 |
| K180192 | Emprint Ablation Visualization Application | Covidien, LLC | LLZ | Class II | 2018-03-21 |
| K172168 | WillCeph | Hdx Will Corp. | LLZ | Class II | 2018-03-21 |
| K173607 | SOMATOM Edge Plus | Siemens Medical Solutions USA, Inc. | JAK | Class II | 2018-03-21 |
| K173408 | Mammomat Revelation | Siemens Medi Cal Solutions, Inc. | MUE | Class II | 2018-03-21 |
| K173451 | Ingenia Elition S and Ingenia Elition X | Philips Medical Systems Nederland B.V. | LNH | Class II | 2018-03-20 |
| K180015 | Philips Incisive CT | Philips Healthcare (Suzhou) Co., Ltd. | JAK | Class II | 2018-03-20 |
| K180129 | Imbio Segmentation Editing Tool software | Imbio, LLC | LLZ | Class II | 2018-03-16 |
| K173611 | syngo Application Software | Siemens Medical Solutions USA, Inc. | LLZ | Class II | 2018-03-16 |
| K180393 | AIRO Computed Tomography (CT) X-ray System | Mobius Imaging, LLC | JAK | Class II | 2018-03-15 |
| K171778 | MR Wireless Gating System, Model WGS-100 | Ivy Biomedical Systems, Inc. | LNH | Class II | 2018-03-14 |
| K180106 | ThinkQA | Dosisoft | IYE | Class II | 2018-03-13 |
| K180374 | Voluson S8/ Voluson S10/ Voluson S10 Expert | GE Healthcare | IYN | Class II | 2018-03-13 |
| K180262 | SICAT Endo | Sicat GmbH & Co. KG | LLZ | Class II | 2018-03-12 |
| K173939 | Quantib Brain | Quantib B.V. | LLZ | Class II | 2018-03-09 |
| K180394 | BrightMatter Plan 1.6.0 | Synaptive Medical, Inc. | LLZ | Class II | 2018-03-09 |
| K173625 | syngo.CT Clinical Extensions | Siemens Medical Solutions USA, Inc. | JAK | Class II | 2018-03-08 |
| K173605 | iQMR | Medic Vision - Imaging Solutions, Ltd. | LLZ | Class II | 2018-03-08 |
| K173713 | HS70A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | 2018-03-08 |
| K180326 | icobrain | Icometrix | LLZ | Class II | 2018-03-08 |
| K173356 | Ingenia Elition S and Ingenia Elition X R5.4 | Philips Medical Systems Nederland B.V. | LNH | Class II | 2018-03-06 |
| K173312 | ProBx Software | Harmonus, Inc. | LLZ | Class II | 2018-03-02 |
| K180265 | COMPACT TOUCH Ophthalmic Ultrasound System | Quantel Medical | IYO | Class II | 2018-03-02 |
| K172256 | SoftVue | Delphinus Medical Technologies | IYO | Class II | 2018-03-02 |
| K172135 | uCT Computed Tomography X-ray System | Shanghai United Imaging Healthcare Co., Ltd. | JAK | Class II | 2018-03-02 |
| K173739 | ALOKA ARIETTA 850 | Hitachi Healthcare Americas Corporation | IYN | Class II | 2018-02-28 |
| K172750 | Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe) | Guangzhou Sonostar Technologies Co., Ltd. | IYO | Class II | 2018-02-28 |
| K173145 | CereMetrix Silver | Ceremetrix Corp | LLZ | Class II | 2018-02-28 |
| K173736 | TrackX | Track X Technology, LLC | OWB | Class II | 2018-02-28 |
| K173468 | Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0 | Toshibamedical Systems Corporation | JAK | Class II | 2018-02-23 |
| K173224 | SPIN-SWI | Spintech, Inc. | LNH | Class II | 2018-02-23 |
| K173569 | Ultrasound System 1300 | Bk Medical Aps | IYN | Class II | 2018-02-23 |
| K173863 | Ez3D-i /E3 | Ewoosoft Co., Ltd. | LLZ | Class II | 2018-02-23 |
| K173689 | Ophthalmic Software Platform RX | Canon Inc. -Medical Equipment Group | NFJ | Class II | 2018-02-23 |
| K170540 | DM-Density | Densitas, Inc. | LLZ | Class II | 2018-02-23 |
| K173513 | WS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | 2018-02-20 |
| K173409 | Wireless Audio System | Neocoil, LLC | LNH | Class II | 2018-02-16 |
| K180123 | Breast BI 7 MR Coil 1.5T Mammavention | Noras Mri Products GmbH | MOS | Class II | 2018-02-16 |
| K173636 | Velocity | Varian Medical Systems, Inc. | LLZ | Class II | 2018-02-15 |
| K173592 | MAGNETOM Aera, MAGNETOM Skyra/Skyrafit, MAGNETOM Prisma/Prismafit, MAGNETOM Avantofit | Siemens Medical Solutions USA, Inc. | LNH | Class II | 2018-02-13 |
| DEN170073 | ContaCT | Viz.Al, Inc. | QAS | Class II | 2018-02-13 |
| K172058 | CT6485, CT12885 | Analogic Corporation | JAK | Class II | 2018-02-13 |
| K170793 | SuRgical Planner (SRP) | Surgical Theater, LLC | LLZ | Class II | 2018-02-12 |
| K173823 | Amrad Medical AAU Digital Radiography System; Amrad Medical AAU Plus Digital Radiography System; Amrad Medical DFMT Digital Radiography System; Amrad Medical FMT Digital Radiography System | Summit Industries, LLC | KPR | Class II | 2018-02-09 |
| K173791 | Leksell GammaPlan | Elekta Instrument AB | IWB | Class II | 2018-02-09 |
| K172180 | OSCAR 15 | Genoray Co., Ltd. | OWB | Class II | 2018-02-09 |
| K171631 | Standard Catheter Set | Varian Medical Systems, Inc. | JAQ | Class II | 2018-02-09 |
| K171755 | CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System | Omega Medical Imaging, LLC | OWB | Class II | 2018-02-09 |
| K180091 | UNiD Spine Analyzer | Medicrea International | LLZ | Class II | 2018-02-08 |
| K180084 | Ultrasound System SONIMAGE MX1 | Konica Minolta, Inc. | IYO | Class II | 2018-02-08 |
| K173244 | superDimension Navigation System V7.2 | Covidien, LLC | JAK | Class II | 2018-02-08 |
| K162727 | SENYINT Remote Consultation System | Dalian Senyint Digital Medical System Co., Ltd. | LLZ | Class II | 2018-02-08 |
| K180067 | ACUSON X800 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | IYN | Class II | 2018-02-07 |
| K172832 | Insight BD | Siemens Medi Cal Solutions, Inc. | LLZ | Class II | 2018-02-06 |
| K172490 | eUnity | Client Outlook, Inc. | LLZ | Class II | 2018-02-06 |
| K173204 | RS85 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | 2018-02-05 |
| K173924 | DRX-Revolution Nano Mobile X-ray System | Carestream Health, Inc. | IZL | Class II | 2018-02-05 |
| K173433 | ProxiDiagnost N90 | Philips Medical Systems Dmc GmbH | OWB | Class II | 2018-02-05 |
| K173512 | MFI-Cardiac | Multifunctional Imaging, LLC | LLZ | Class II | 2018-02-05 |
| K173981 | ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. Ultrasound Group | IYN | Class II | 2018-02-02 |
| K180039 | ACUSON P600 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | IYN | Class II | 2018-02-01 |
| K173957 | ACUSON NX3 Diagnostic Ultrasound System; ACUSON NX3 ELITE Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | IYN | Class II | 2018-02-01 |
| K173088 | Vitrea Software Toshiba Package VSTP-001A | Toshibamedical Systems Corporation | LLZ | Class II | 2018-01-31 |
| K173382 | Vantage Galan 3T, V4.6 | Toshibamedical Systems Corporation | LNH | Class II | 2018-01-26 |
| K173299 | DRAGON X SPSL4HC, DRAGON X SPSL8HC | Sedecal., Sa. | IZL | Class II | 2018-01-26 |
| K173558 | SyMRI | Syntheticmr AB | LNH | Class II | 2018-01-26 |
| K173953 | uDR 780i | Shanghai United Imaging Healthcare Co., Ltd. | KPR | Class II | 2018-01-26 |
| K173542 | Arterys Oncology DL | Arterys, Inc. | LLZ | Class II | 2018-01-25 |
| K171528 | Bladder Scanner (model: PadScan DS3, PadScan Z3, PadScan Z5) | Avantsonic Technology Co., Ltd. | IYO | Class II | 2018-01-24 |
| K172920 | 3D APT | Philips Medical Systems Nederland B.V. | LNH | Class II | 2018-01-22 |
14,721 clearances in the Radiology panel. Data: openFDA.