Review Panel
Radiology FDA 510(k) Clearances & Devices
- Cleared Devices
- 14,721
- Product Codes (page)
- 23
- Latest Decision
- 2018-01-19
Clearances · page 38 of 148
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K173878 | PreXion3D Excelsior | Prexion Corporation | OAS | Class II | 2018-01-19 |
| K173478 | OnSight 3D Extremity System | Carestream Health, Inc. | JAK | Class II | 2018-01-19 |
| K173838 | ARIA Radiation Therapy Management | Varian Medical Systems, Inc. | IYE | Class II | 2018-01-17 |
| K173054 | Navigo Workstation Version 2.0 | UC-CARE , Ltd. | LLZ | Class II | 2018-01-16 |
| K173622 | CS Imaging | Trophy | LLZ | Class II | 2018-01-16 |
| K173547 | ImagenUniversal | Cardiovascular Imaging Technologies | KPS | Class II | 2018-01-12 |
| K173828 | GU60A & GU60A-65 | Samsung Electronics Co., Ltd. | KPR | Class II | 2018-01-12 |
| K173291 | 6440 Ultrasound System | Esaote, S.p.A. | IYN | Class II | 2018-01-12 |
| K173602 | Optima XR240amx, AutoGrid | Ge Medical Systems, LLC | IZL | Class II | 2018-01-12 |
| K173635 | syngo.via RT Image Suite | Siemens Medical Solutions USA, Inc. | MUJ | Class II | 2018-01-12 |
| K173588 | Illumeo System | Philips Medical Systems Technologies , Ltd. | LLZ | Class II | 2018-01-12 |
| K173090 | Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4 | Toshibamedical Systems Corporation | IYN | Class II | 2018-01-11 |
| K172224 | DTX Studio diagnose | Nobel Biocare AB | LLZ | Class II | 2018-01-11 |
| K172110 | ECHELON OVAL V6.0A MRI System | Hitachi Healthcare Americas Corporation | LNH | Class II | 2018-01-11 |
| K173021 | Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic Systems | Supersonic Imagine | IYN | Class II | 2018-01-09 |
| K163027 | Ultra/Phonic Free Conductivity Gel | Pharmaceutical Innovations, Inc. | MUI | Class II | 2018-01-09 |
| K173469 | 16ch T/R Hand Wrist Coil | Quality Electrodynamics, LLC | MOS | Class II | 2018-01-09 |
| K163026 | Ultra/Phonic Scanning Gel | Pharmaceutical Innovations, Inc. | MUI | Class II | 2018-01-09 |
| K173471 | DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | Class II | 2018-01-08 |
| K163024 | Ultra/Phonic Conductivity Gel | Pharmaceutical Innovations, Inc. | MUI | Class II | 2018-01-08 |
| K171328 | cNeuro cMRI | Combinostics OY | LLZ | Class II | 2018-01-08 |
| K163023 | Other-Sonic Transmission Gel | Pharmaceutical Innovations, Inc. | MUI | Class II | 2018-01-08 |
| K173456 | ViewPoint 6 | Ge Medical Systems Ultrasound and Primary | LLZ | Class II | 2018-01-05 |
| K163712 | Clover 50/Clover60/Clover70 Diagnostic Ultrasound System | Shenzhen Wisonic Medical Technology Co. , Ltd. | IYN | Class II | 2018-01-02 |
| K172860 | Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite Diagnostic Ultrasound System/Resona 6S/Resona 6PRO/Resona 6OB Diagnostic Ultrasound System /Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | Class II | 2018-01-02 |
| K173664 | Medtronic O-arm O2 Imaging System | Medtronic, Inc. | OWB | Class II | 2017-12-29 |
| K163328 | Planmed Clarity | Planmed OY | MUE | Class II | 2017-12-28 |
| K172848 | MEVION S250i Proton Beam Radiation Therapy Device | Mevion Medical Systems | LHN | Class II | 2017-12-27 |
| K173420 | Radiomics App v1.0 | Microsoft Corp. | LLZ | Class II | 2017-12-27 |
| K171049 | Real Time Image Gating System for Proton Beam Therapy Systems | Hitachi, Ltd. Healthcare | LHN | Class II | 2017-12-26 |
| K172706 | GammaPod - Model A | Xcision Medical Systems, LLC | IWB | Class II | 2017-12-22 |
| K173578 | Biograph mCT Family of PET/CT Systems | Siemens Medical Solutions USA, Inc. | KPS | Class II | 2017-12-20 |
| K173555 | LOGIQ E10 | GE Healthcare | IYN | Class II | 2017-12-20 |
| K171012 | Veraview X800 | J. Morita USA, Inc. | OAS | Class II | 2017-12-19 |
| K173251 | LumiCoil Platinum Fiducial Marker | Boston Scientific Corporation | IYE | Class II | 2017-12-19 |
| K173600 | MAGNETOM Amira | Siemens Medical Solutions USA, Inc. | LNH | Class II | 2017-12-19 |
| K172732 | E-CUBE 8 | Alpinion Medical Systems Co., Ltd. | IYN | Class II | 2017-12-14 |
| K172863 | Infinix-i, INFX-8000V, V7.0 | Toshibamedical Systems Corporation | OWB | Class II | 2017-12-14 |
| K173434 | 2MP Color LCD Monitor CL-S200, 3MP Color LCD Monitor CL-S300 | Jvckenwood Corporation | PGY | Class II | 2017-12-14 |
| K172056 | InnoSight Diagnostic Ultrasound System | Qisda Corporation | IYO | Class II | 2017-12-13 |
| K173369 | DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. | IYN | Class II | 2017-12-13 |
| K172276 | Xario 200 Diagnostic Ultrasound System V6.0 | Toshibamedical Systems Corporation | IYN | Class II | 2017-12-12 |
| K173467 | Advanced Diffusion Analysis (ADA) application | Philips Medical Systems Nederland B.V. | LLZ | Class II | 2017-12-12 |
| K173612 | Optima XR646 HD | Ge Hualun Medical Systems Co. , Ltd. | KPR | Class II | 2017-12-11 |
| K171677 | Clear Guide SCENERGY | Clear Guide Medical | JAK | Class II | 2017-12-08 |
| K173475 | Merge PACS | Merge Healthcare Incorporated | LLZ | Class II | 2017-12-08 |
| K172222 | 8ch Flex Suite | Shenzhen RF Tech Co., Ltd. | MOS | Class II | 2017-12-08 |
| K173000 | Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color Doppler Ultrasound Imaging System | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) | IYN | Class II | 2017-12-07 |
| K171198 | NeuViz 16 Essence Multi-slice CT Scanner System | Neusoft Medical Systems Co., Ltd. | JAK | Class II | 2017-12-07 |
| K170046 | Lilium a-200E | Lilium Otsuka Co., Ltd. | IYO | Class II | 2017-12-07 |
| K172993 | P20 Series Digital Color Doppler Ultrasound System | Sonoscape Medical Corp. | IYN | Class II | 2017-12-05 |
| K172931 | DUS-6000 Digital Ultrasonic Diagnostic Imaging System | Advanced Instrumentations, Inc. | IYO | Class II | 2017-12-01 |
| K171352 | EZFluence | Radformation, Inc. | IYE | Class II | 2017-12-01 |
| K173058 | P10 Series Digital Color Doppler Ultrasound System | Sonoscape Medical Corp. | IYN | Class II | 2017-12-01 |
| K171350 | Collision Check | Radformation, Inc. | IYE | Class II | 2017-11-29 |
| K173377 | 3.0T 16ch Breast Coil | Neocoil, LLC | MOS | Class II | 2017-11-28 |
| K173290 | DuoFLEX Coil Suite | Mr Instruments, Inc. | MOS | Class II | 2017-11-28 |
| K170946 | Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray System - 110V Variant | Skanray Technologies Private Limited | OXO | Class II | 2017-11-24 |
| K172539 | CereTom Elite | Neurologica Corporation, A Subsidiary of Samsung Electronics | JAK | Class II | 2017-11-22 |
| K172822 | Azurion series R1.2 | Philips Medical Systems Nederland B.V. | OWB | Class II | 2017-11-22 |
| K172229 | GC85A | Samsung Electronics Co., Ltd. | KPR | Class II | 2017-11-22 |
| K172695 | AIR Anterior Array, AIR Posterior Array | Ge Healthcare Coils (Usa Instruments, Inc.) | MOS | Class II | 2017-11-22 |
| K171681 | Hermes Medical Imaging Suite v5.7 | Hermes Medical Solutions AB | KPS | Class II | 2017-11-21 |
| K172685 | LiverMultiScan | Perspectum Diagnostics, Ltd. | LNH | Class II | 2017-11-21 |
| K172218 | MIM Y90 Dosimetry | Mim Software, Inc. | LLZ | Class II | 2017-11-21 |
| K171719 | Hybrid3D | Hermes Medical Solutions AB | KPS | Class II | 2017-11-21 |
| K173378 | syngo®.via protoNeo (Version VA20) | Siemens Healthcare GmbH | LLZ | Class II | 2017-11-20 |
| K173018 | MDR17 Mobile Direct Radiographic System | Del Medical, Inc. | IZL | Class II | 2017-11-20 |
| K173446 | Contour 24 | Quality Electrodynamics, LLC | MOS | Class II | 2017-11-17 |
| K173023 | Symbia T16, Symbia Intevo 16 and Symbia Intevo Bold | Siemens Medical Solutions USA, Inc. | KPS | Class II | 2017-11-17 |
| K170856 | CMS600P2 B-Ultrasound Diagnostic System | Contec Medical Systems Co.,Ltd | IYO | Class II | 2017-11-17 |
| K171270 | DIGITAL RADIOGRAPHY CXDI-410C WIRELESS | Canon, Inc. | MQB | Class II | 2017-11-17 |
| K172878 | Vantage Titan 3T, MRT-3010/A7, M-Power GX | Toshiba Medical Systems Corporation, Japan | LNH | Class II | 2017-11-17 |
| K172550 | OEC Elite | Ge Oec Medical Systems, Inc. | OXO | Class II | 2017-11-16 |
| K173314 | LessRay System | Nu Vasive, Incorporated | OWB | Class II | 2017-11-16 |
| K163643 | SIRIO H3 | Masmec Spa | JAK | Class II | 2017-11-16 |
| K173187 | MobileDiagnost M50 | Philips India Limited | IZL | Class II | 2017-11-16 |
| K173329 | jFit Surgical Planner | Jointvue, LLC | LLZ | Class II | 2017-11-15 |
| K173003 | U50 Diagnostic Ultrasound System | Edan Instruments, Inc. | IYN | Class II | 2017-11-15 |
| K172531 | Biograph mMR with mMR Angio Transfer Option | Siemens Medical Solutions USA, Inc. | OUO | Class II | 2017-11-14 |
| K173034 | FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) | Echosens | IYO | Class II | 2017-11-14 |
| K170859 | Dolphin/IQ and Dolphin/4D | Viasonix , Ltd. | IYN | Class II | 2017-11-14 |
| K171385 | Planmeca Romexis | Planmeca Oy | LLZ | Class II | 2017-11-14 |
| K173273 | Aquarius 8600 1417WCI; Aquarius 8600 1717WCI | Imaging Dynamics Company , Ltd. | MQB | Class II | 2017-11-09 |
| K172700 | OEC One | Ge Hualun Medical Systems Co. , Ltd. | OWB | Class II | 2017-11-09 |
| K171467 | BioZorb Marker GOLD / LP Marker GOLD | Focal Therapeutics | IYE | Class II | 2017-11-09 |
| K171850 | Philips CT Big Bore | Philips Medical Systems (Cleveland), Inc. | JAK | Class II | 2017-11-09 |
| K172124 | Televere Podiatry Digital Imaging System | Televere Systems | MQB | Class II | 2017-11-09 |
| K171534 | SurgicalPreview | Endo Vantage, LLC | PZO | Class II | 2017-11-08 |
| K172738 | RadiForce RX560, RX560-AR | Eizo Corporation | PGY | Class II | 2017-11-08 |
| K173247 | Surgical Planning Software version 1.1 | Ortho Kinematics, Inc. | LLZ | Class II | 2017-11-08 |
| K173265 | UltraVision 2 Diagnostic Ultrasound System | Winprobe Corporation | IYN | Class II | 2017-11-07 |
| K172609 | CSMC Cardiac Suite | Cedars-Sinai Medical Center | KPS | Class II | 2017-11-03 |
| K173341 | Vivid E80, Vivid E90, Vivid E95 | GE Medical Systems | IYN | Class II | 2017-11-02 |
| K171370 | IMAGEnet 6 Ophthalmic Data System | Topcon Corporation | NFJ | Class II | 2017-11-01 |
| K171708 | ALOKA ARIETTA 850 | Hitachi Healthcare Americas Corporation | IYN | Class II | 2017-10-31 |
| K172404 | SenoBright HD | GE Healthcare | MUE | Class II | 2017-10-30 |
| K172646 | XIDF-AWS801, Angio Workstation, V7.0 | Toshibamedical Systems Corporation | OWB | Class II | 2017-10-30 |
| K172803 | Infinitt PACS 7.0 | Infinitt Healthcare Co., Ltd. | LLZ | Class II | 2017-10-27 |
| K173138 | Biim Diagnostic Ultrasound System | Biim Ultrasound AS | IYO | Class II | 2017-10-27 |
14,721 clearances in the Radiology panel. Data: openFDA.