Review Panel
Radiology FDA 510(k) Clearances & Devices
- Cleared Devices
- 14,721
- Product Codes (page)
- 25
- Latest Decision
- 2017-10-27
Clearances · page 39 of 148
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K172815 | 2MP LCD Monitor (G22S+, G22SP+, C22S+, C22SP+) | Shenzhen Beacon Display Technology Co., Ltd. | PGY | Class II | 2017-10-27 |
| K170345 | SOFTDISO | Best Nomos | IYE | Class II | 2017-10-27 |
| K172534 | LINACwatch, LinacView | Qualiformed Sarl | IYE | Class II | 2017-10-27 |
| K171926 | C5 Diagnostic Ultrasound System | Guangzhou Sonostar Technologies Co., Ltd. | IYN | Class II | 2017-10-27 |
| K173132 | ASPIRE Cristalle | Fujifilm Medical Systems U.S.A, Inc. | MUE | Class II | 2017-10-27 |
| K173094 | OrthoVision | Ewoosoft Co., Ltd. | LLZ | Class II | 2017-10-26 |
| K163050 | Advance Medical Designs, Inc. Sterile Ultrasound Gel | Advance Medical Designs, Inc. | MUI | Class II | 2017-10-25 |
| K172455 | CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2 Installation Kit | Volcano Corporation | IYO | Class II | 2017-10-25 |
| K170307 | SunCHECK | Sun Nuclear Corporation | IYE | Class II | 2017-10-25 |
| K172970 | M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | Class II | 2017-10-25 |
| K172307 | Dynamic Coronary Roadmap 2.0 | Philips Medical Systems Nederland B.V. | OWB | Class II | 2017-10-24 |
| K172951 | Nexus DR Digital X-ray Imaging System (with PaxScan 4343RC and PaxScan 4343Rv3) | Varex Imaging Corporation | MQB | Class II | 2017-10-24 |
| K171709 | BR-FHUS Viewer 1.0 | Taihao Medical, Inc. | LLZ | Class II | 2017-10-20 |
| K171594 | Accuro | Rivanna Medical, LLC | IYO | Class II | 2017-10-20 |
| K160405 | OCTAVIUS I, OCTAVIUS II, OCTAVIUS III, OCTAVIUS 4D | Ptw-Freiburg Physikalisch-Technische-Werkstaetten | IYE | Class II | 2017-10-20 |
| K172869 | Discovery XR656 HD | Ge Hualun Medical Systems Co. , Ltd. | KPR | Class II | 2017-10-20 |
| K163623 | Quantra | Hologic, Inc. | LLZ | Class II | 2017-10-20 |
| K172027 | Adani MammoScan | Adani | MUE | Class II | 2017-10-20 |
| K173101 | Curve Image 2.0 PACS | Curve Dental, Ltd. | LLZ | Class II | 2017-10-18 |
| K171579 | M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | Class II | 2017-10-18 |
| K171068 | OrthoView 7.2 | Meridian Technique, Ltd. | LLZ | Class II | 2017-10-18 |
| K172435 | Galaxy R Digital Radiography Upgrade | Medien International Co, Ltd. | MQB | Class II | 2017-10-13 |
| K172784 | DX-D Imaging Package | Agfa Healthcare N.V. | MQB | Class II | 2017-10-13 |
| K170840 | MAGNETOM Terra | Siemens Medical Solutions USA, Inc. | LNH | Class II | 2017-10-12 |
| K172793 | SKR 3000 | Konica Minolta, Inc. | MQB | Class II | 2017-10-12 |
| K171169 | Aquarius 8600 1417TG and Aquarius 8600 1717TG | Imaging Dynamics Company , Ltd. | MQB | Class II | 2017-10-12 |
| K170085 | SONON Ultrasound Imaging System, Model: 300L | Healcerion Co., Ltd. | IYN | Class II | 2017-10-12 |
| K172682 | Edge Digital Flat Panel X-ray Detector | Osko, Inc. | MQB | Class II | 2017-10-06 |
| K172406 | Ingenuity TF | Philips Medical Systems (Cleveland), Inc. | KPS | Class II | 2017-10-06 |
| K172188 | Aquilion Prime SP, TSX-303B/1, v8.4 | Toshiba Medical Systems Coroporation | JAK | Class II | 2017-10-06 |
| K172681 | Edge Air Digital Flat Panel X-ray Detector | Osko, Inc. | MQB | Class II | 2017-10-06 |
| K171175 | Aquarius 8600 1417WC | Imaging Dynamics Company , Ltd. | MQB | Class II | 2017-10-05 |
| K172855 | Vitrea Advanced Visualization, Version 7.6 | Vital Images, Inc. | LLZ | Class II | 2017-10-05 |
| K172574 | SyncVision System | Volcano Corporation | OWB | Class II | 2017-10-05 |
| K172059 | LinkQuest Diagnostic Ultrasound System model SQ860 | Linkquest, Inc. | IYN | Class II | 2017-10-05 |
| K172607 | Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System | Philips Health Care | IYN | Class II | 2017-10-04 |
| K172380 | U2 Diagnostic Ultrasound System | Edan Instruments, Inc. | IYN | Class II | 2017-09-29 |
| K171309 | BR-FHUS Navigation 1.0 | Taihao Medical, Inc. | IYO | Class II | 2017-09-29 |
| K172342 | Voluson E6, Voluson E8, Voluson E10 | GE Healthcare | IYN | Class II | 2017-09-29 |
| K171463 | ASPIRE Bellus II | Fujifilm Medical Systems U.S.A, Inc. | LLZ | Class II | 2017-09-29 |
| K172080 | Photoelectric Therapy System | Xstrahl, Ltd. | JAD | Class II | 2017-09-29 |
| K170816 | Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature Correction, Elements TRAM | Brainlab AG | LLZ | Class II | 2017-09-26 |
| K172581 | CareView 1800Cw X-ray Flat Panel Detectors | Careray Digital Medical System Co., Ltd. | MQB | Class II | 2017-09-26 |
| K171303 | Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664 | University of Texas Medical School AT Houston, Texas | KPS | Class II | 2017-09-22 |
| K171829 | EndoNaut | Therenva Sas | OWB | Class II | 2017-09-21 |
| K171804 | Zap-X Radiosurgery System | Zap Surgical Systems | IYE | Class II | 2017-09-21 |
| K171891 | ZS3 Ultrasound System, z.one pro Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | Class II | 2017-09-21 |
| K172082 | S60 Series Digital Color Doppler Ultrasound System | Sonoscape Medical Corp. | IYN | Class II | 2017-09-21 |
| K172356 | BladderScan Prime PLUS System | Verathon Incorporated | IYO | Class II | 2017-09-15 |
| K172385 | Clarius Ultrasound System | Clarius Mobile Health Corp. | IYN | Class II | 2017-09-14 |
| K172513 | 3D Echo | Jointvue, LLC | LLZ | Class II | 2017-09-14 |
| K172142 | FibroScan 430 Mini+ | Echosens | IYO | Class II | 2017-09-13 |
| K171201 | NeuViz Prime Multi-slice CT Scanner System | Neusoft Medical Systems Co., Ltd. | JAK | Class II | 2017-09-13 |
| K171233 | Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. | IYN | Class II | 2017-09-12 |
| K170981 | NeuroQuant | Cortechs Labs, Inc. | LLZ | Class II | 2017-09-07 |
| K163510 | Poseidon Ultrasound System | Butterfly Network, Inc. | IYN | Class II | 2017-09-06 |
| K163302 | Senographe Pristina | GE Healthcare | MUE | Class II | 2017-09-01 |
| K163423 | Orthopantomograph OP300 | Palodex Group OY | OAS | Class II | 2017-08-31 |
| K172055 | DUS-7000 Digital Color Doppler Ultrasound System | Advanced Instrumentations, Inc. | IYN | Class II | 2017-08-31 |
| K162533 | Kelowna GYN and Crook Prostate Templates | Varian Medical Systems, Inc. | JAQ | Class II | 2017-08-31 |
| K162943 | SyMRI | Syntheticmr AB | LNH | Class II | 2017-08-29 |
| K171487 | Sirius MRI Marker NS | C4 Imaging, LLC | KXK | Class II | 2017-08-25 |
| K172327 | VMA System version 3.0 | Ortho Kinematics, Inc. | LLZ | Class II | 2017-08-25 |
| K171560 | OTIS Optical Coherence Tomography System | Perimeter Medical Imaging, Inc. | NQQ | Class II | 2017-08-25 |
| K171716 | SKR 3000 | Konica Minolta, Inc. | MQB | Class II | 2017-08-25 |
| K170750 | RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review | Brainlab AG | MUJ | Class II | 2017-08-24 |
| K171048 | RS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | 2017-08-24 |
| K172364 | EzDent-i / E2 / Prora View | Ewoosoft Co., Ltd. | LLZ | Class II | 2017-08-22 |
| K171617 | OKI Surgical Planning Software | Ortho Kinematics, Inc. | LLZ | Class II | 2017-08-22 |
| K171183 | OmniTom | Neurologica Corporation | JAK | Class II | 2017-08-18 |
| K171261 | ScannerSide DoseCheck | Right Dose, Inc. | JAK | Class II | 2017-08-18 |
| K170800 | NuVasive LessRay with Enhanced Tracking | Nu Vasive, Incorporated | OWB | Class II | 2017-08-18 |
| K171900 | Acclarix AX4 Diagnostic Ultrasound System | Edan Instruments, Inc. | IYN | Class II | 2017-08-18 |
| K171738 | Supria True64 | Hitachi Healthcare Americas Corporation | JAK | Class II | 2017-08-18 |
| K163500 | IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class) | Ion Beam Applications S.A. | LHN | Class II | 2017-08-17 |
| K172162 | ACUSON S3000 S2000 S1000 Diagnostic Ultrasound Systems | Siemens Healthcare | IYN | Class II | 2017-08-16 |
| K172374 | ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | IYN | Class II | 2017-08-15 |
| K172163 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | MUJ | Class II | 2017-08-15 |
| K171565 | OEC Elite | Ge Oec Medical Systems, Inc. | OWB | Class II | 2017-08-10 |
| K163121 | SmartUs EXT-1M/3M | Telemed | IYN | Class II | 2017-08-10 |
| K171070 | WS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | 2017-08-09 |
| K172129 | HS40 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | 2017-08-08 |
| K171164 | U-Lite EXP | Sonoscanner | IYN | Class II | 2017-08-03 |
| K171356 | Clarity Reveal | Ceevra, Inc. | LLZ | Class II | 2017-08-03 |
| K171301 | Scanmate Flex | Dgh Technology, Inc. | IYO | Class II | 2017-07-31 |
| K171040 | Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range | Koelis | ITX | Class II | 2017-07-31 |
| K171754 | NovaPACS | Novarad Corporation | LLZ | Class II | 2017-07-28 |
| K163048 | Smart Stitching Software System, Image Processing, Radiological | Osko, Inc. | LLZ | Class II | 2017-07-28 |
| K172013 | VitalBeam | Varian Medical Systems, Inc. | IYE | Class II | 2017-07-28 |
| K170841 | BiopSee, Mobile US | Medcom GmbH | LLZ | Class II | 2017-07-26 |
| K171515 | NHAC 16 | Lmt Medical Systems GmbH | MOS | Class II | 2017-07-26 |
| K171885 | Radiance V4 | Gmv Soluciones Globales Internet S.A.U. | MUJ | Class II | 2017-07-25 |
| K171734 | HP PRO Positioning Device | Orfit Industries NV | IYE | Class II | 2017-07-25 |
| K171837 | TomoTherapy Treatment Delivery System with iDMS | Accuray Incorporated | IYE | Class II | 2017-07-25 |
| K162991 | YELLOW 560 Fluorescence Module | Carl Zeiss Meditec, AG | IZI | Class II | 2017-07-24 |
| K170832 | Ultimax-i, DREX-UI80 V1.60 | Toshibamedical Systems Corporation | OWB | Class II | 2017-07-21 |
| K163232 | Vitrea View | Vital Images, Inc. | LLZ | Class II | 2017-07-21 |
| K171597 | Vantage Elan 1.5T, V4.0 | Toshibamedical Systems Corporation | LNH | Class II | 2017-07-21 |
| K163388 | XPress BCD Breast Compression Device | Xpress Bcd, LLC | POY | Class II | 2017-07-19 |
| DEN170022 | QuantX | Quantitative Insights, Inc. | POK | Class II | 2017-07-19 |
14,721 clearances in the Radiology panel. Data: openFDA.