Review Panel
Radiology FDA 510(k) Clearances & Devices
- Cleared Devices
- 14,721
- Product Codes (page)
- 30
- Latest Decision
- 2019-11-22
Clearances · page 31 of 148
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K192157 | 6450 Ultrasound system | Esaote, S.p.A. | IYN | Class II | 2019-11-22 |
| K193017 | EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP | DRTECH Corporation | MQB | Class II | 2019-11-22 |
| K192061 | SOMATOM Go Platform SOMATOM go.Now, go.Up, go.All, go.Top, go.Sim, go.Open Pro, Scan & GO | Siemens Medical Solutions USA, Inc. | JAK | Class II | 2019-11-21 |
| K192672 | uPMR 790 | Shanghai United Imaging Healthcare Co., Ltd. | OUO | Class II | 2019-11-20 |
| K190497 | Ziehm 8000 | Ziehm Imaging GmbH | OWB | Class II | 2019-11-20 |
| K191278 | RSI-MRI+ | Multimodal Imaging Services Corporation (Dba Healthlytix) | LLZ | Class II | 2019-11-19 |
| K192573 | Dolphin Medical Imaging USB Ultrasound System | Dolphin Medical Imaging, LLC | IYO | Class II | 2019-11-19 |
| K192936 | Soltus 500 | Sedecal., Sa. | IZL | Class II | 2019-11-15 |
| K191171 | EchoGo Core | Ultromics, Ltd. | QIH | Class II | 2019-11-13 |
| K192932 | FDR D-EVO III flat panel detector system | Fujifilm Corporation | MQB | Class II | 2019-11-12 |
| K192968 | IDENTIFY | Varian Medical Systems, Inc. | IYE | Class II | 2019-11-12 |
| K192819 | OEC Elite | Ge Oec Medical Systems, Inc. | OXO | Class II | 2019-11-08 |
| K191959 | QuantX Breast MRI Biopsy Guidance Plugin | Qlarity Imaging | LLZ | Class II | 2019-11-08 |
| K192632 | DIGITAL RADIOGRAPHY CXDI-702C Wireless, DIGITAL RADIOGRAPHY CXDI-402C Wireless | Canon, Inc. | MQB | Class II | 2019-11-07 |
| K191026 | MEDIP PRO | Medical IP Co., Ltd. | LLZ | Class II | 2019-11-07 |
| K191891 | SOMATOM X.cite | Siemens Medical Solutions USA, Inc. | JAK | Class II | 2019-11-06 |
| K192109 | KOALA | Ib Lab GmbH | LLZ | Class II | 2019-11-05 |
| K190868 | Cleerly Labs | Cleerly, Inc. | LLZ | Class II | 2019-11-05 |
| K190330 | DRX-Evolution/Plus with Dual Energy | Carestream Health, Inc. | KPR | Class II | 2019-11-04 |
| K192440 | FDR SE Lite | Fujifilm Corporation | MQB | Class II | 2019-11-01 |
| K192743 | VisionX 2.4 | Durr Dental SE | LLZ | Class II | 2019-10-31 |
| K183412 | mediCAD Web | Medicad Hectec GmbH | LLZ | Class II | 2019-10-31 |
| K191007 | Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems | Supersonic Imagine | IYN | Class II | 2019-10-25 |
| K192690 | Upgrade Kit MR GUI PRO, MrJ 3300 Plus | Asg Superconductors S.P.A. | LNH | Class II | 2019-10-24 |
| K191944 | MU2net | Dosisoft | IYE | Class II | 2019-10-24 |
| K192686 | Revolution Maxima, Revolution Ace | Ge Hangwei Medical Systems Co., Ltd. | JAK | Class II | 2019-10-24 |
| K192737 | RCT800 | Ray Co., Ltd. | OAS | Class II | 2019-10-22 |
| K192835 | ACUSON NX3 Diagnostic Ultrasound System / ACUSON NX3 Elite Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | IYN | Class II | 2019-10-22 |
| K190646 | QT Scanner 2000 Model A | Qt Ultrasound, LLC | IYO | Class II | 2019-10-18 |
| K183274 | RTHawk, HeartVista Cardiac Package | Heartvista, Inc. | LNH | Class II | 2019-10-18 |
| K191544 | Synapse 3D Blood Flow Analysis | Fujifilm Corporation | LLZ | Class II | 2019-10-18 |
| K192455 | Merge PACS | Merge Healthcare Incorporated | LLZ | Class II | 2019-10-17 |
| K191216 | Voxel Dosimetry v1.0 | Hermes Medical Solutions AB | LLZ | Class II | 2019-10-17 |
| K190162 | SmartCeph | Ortho2, LLC | LLZ | Class II | 2019-10-17 |
| K192541 | DigiX FDX | Allengers Medical Systems Limited | KPR | Class II | 2019-10-16 |
| K191493 | Ventripoint Medical System Plus (VMS+) 3.0 | Ventripoint Diagnostics , Ltd. | LLZ | Class II | 2019-10-16 |
| K192512 | Focus 35C Detector, Trimax 35C Detector | Iray Technology Taicang , Ltd. | MQB | Class II | 2019-10-16 |
| K190772 | SURGICAL MICROSCOPE SYSTEM ORBEYE with IR | Olympus Medical Systems Corp. | IZI | Class II | 2019-10-10 |
| K192200 | DynaCAD | Invivo Corporation | LLZ | Class II | 2019-10-09 |
| K190314 | Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000 | Mednovel Technology, Ltd. | IYO | Class II | 2019-10-09 |
| K191994 | ProFound AI Software V2.1 | Icad, Inc. | QDQ | Class II | 2019-10-04 |
| K191713 | CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield (ROI Assembly) | Omega Medical Imaging, LLC | JAA | Class II | 2019-10-04 |
| K190591 | Safergel Sterile Ultrasound Gel | Safersonic Us, Inc. | MUI | Class II | 2019-10-04 |
| K192400 | EVS 4343A, EVS 4343AG, EVS 3643A, EVS 3643AG | DRTECH Corporation | MQB | Class II | 2019-10-03 |
| K192424 | Mobius3D | Varian Medical Systems, Inc. | IYE | Class II | 2019-10-03 |
| K192427 | Ablation Confirmation | Neuwave Medical, Inc. | JAK | Class II | 2019-10-03 |
| K191332 | XACT Robotic System | Xact Robotics, Ltd. | JAK | Class II | 2019-10-03 |
| K191610 | RTapp | Segana, LLC | LLZ | Class II | 2019-10-01 |
| K192453 | DIAMOND-5A/6A/8A | DRGEM Corporation | KPR | Class II | 2019-10-01 |
| K192303 | ExactVu High Resolution Micro-Ultrasound System | Exact Imaging, Inc. | IYN | Class II | 2019-10-01 |
| K192426 | Signa Voyager, Signa Voyager Quantum | Ge Healthcare (Tianjin) Company Limited | LNH | Class II | 2019-10-01 |
| K190024 | Smart-C | Turner Imaging Systems, Inc. | OXO | Class II | 2019-09-27 |
| K191521 | Radiance 330 Proton Beam Therapy System | Protom International Holding Corporation | LHN | Class II | 2019-09-27 |
| K192364 | GXR-Series Diagnostic X-Ray System | DRGEM Corporation | KPR | Class II | 2019-09-26 |
| K191530 | StoneChecker | Imaging Biometrics, LLC | LLZ | Class II | 2019-09-26 |
| K192435 | NuVasive NuvaLine | Nu Vasive, Incorporated | LLZ | Class II | 2019-09-26 |
| K192102 | Thermoplastic Masks | Aktina Medical Corporation | IYE | Class II | 2019-09-25 |
| K192011 | PhoeniX | Sedecal., Sa. | IZL | Class II | 2019-09-25 |
| K190856 | SeeFactorCT3 | Epica International, Inc. | OAS | Class II | 2019-09-20 |
| K192402 | syngo.CT Extended Functionality | Siemens Medical Solutions USA, Inc. | JAK | Class II | 2019-09-20 |
| K191324 | CivaDerm | Civatech Oncology, Inc. | KXK | Class II | 2019-09-20 |
| K192276 | Merge Cardio | Merge Healthcare Incorporated | LLZ | Class II | 2019-09-20 |
| K191112 | GEHC DXA Bone Densitometers with enCORE version 18 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | KGI | Class II | 2019-09-19 |
| K192030 | RS80 EVO Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | 2019-09-19 |
| K191663 | Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0 | Canon Medical Systems Corporation | IYN | Class II | 2019-09-18 |
| K192065 | Syngo.Via RT Image Suite | Siemens Medical Solutions USA, Inc. | MUJ | Class II | 2019-09-18 |
| K192254 | InnoSight Diagnostic Ultrasound System | Qisda Corporation | IYN | Class II | 2019-09-18 |
| K190049 | Sim&Size | Sim&Cure | PZO | Class II | 2019-09-17 |
| K191688 | SubtleMR | Subtle Medical, Inc. | LLZ | Class II | 2019-09-16 |
| K190841 | SCENARIA View | Hitachi Healthcare Americas | JAK | Class II | 2019-09-13 |
| K191801 | PROBEAT-CR | Hitachi , Ltd. | LHN | Class II | 2019-09-13 |
| K192304 | SIS Software Version 3.6.0 | Surgical Information Sciences, Inc. | LLZ | Class II | 2019-09-13 |
| K190768 | ARTIS icono | Siemens Medical Solutions USA, Inc. | OWB | Class II | 2019-09-12 |
| K190780 | syngo Application Software | Siemens Medical Solution USA, Inc. | LLZ | Class II | 2019-09-12 |
| K192293 | uDR 592h, uDR 596i | Shanghai United Imaging Healthcare Co., Ltd. | KPR | Class II | 2019-09-12 |
| K192199 | CRC PC Smart Chamber K1 | Capintec, Inc. | KPT | Class II | 2019-09-12 |
| K183268 | AI-Rad Companion (Cardiovascular) | Siemens Medical Solutions USA, Inc. | JAK | Class II | 2019-09-10 |
| K190668 | Encompass 15 Channel Head Coil, 3T | Qfix | MOS | Class II | 2019-09-09 |
| K191845 | Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive Workflow Tools (IWT) | Barco N.V. | PGY | Class II | 2019-09-06 |
| K183525 | EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F | Olympus Medical Systems Corp. | PSV | Class II | 2019-09-06 |
| K192188 | Aquilion ONE (TSX-306A/3) V10.0 | Canon Medical Systems Corporation | JAK | Class II | 2019-09-06 |
| K192226 | Lumify Diagnostic Ultrasound System | Philips Health Care | IYN | Class II | 2019-09-06 |
| K190844 | Akesis Galaxy | Akesis, Inc. | IWB | Class II | 2019-09-04 |
| K191503 | MobileRay Pulse SE Digital Imaging System | Portavision Medical, LLC | OWB | Class II | 2019-09-04 |
| K183475 | T1-CS, T1-C | Osstem Implant Co., Ltd. | OAS | Class II | 2019-08-30 |
| K192107 | Clarius Ultrasound Scanner | Clarius Mobile Health Corp. | IYN | Class II | 2019-08-29 |
| K192159 | Voluson E6, Voluson E8, Voluson E10 | GE Healthcare | IYN | Class II | 2019-08-29 |
| K183489 | D2P | 3D Systems, Inc. | LLZ | Class II | 2019-08-29 |
| K191939 | Yushan X-Ray Flat Panel Detector | Innocare Optoelectronics Corp. | MQB | Class II | 2019-08-29 |
| K183544 | Efficient Care 3D Planning | Orthosoft Inc (D/B/A Zimmer Cas) | LLZ | Class II | 2019-08-23 |
| K182086 | ARCO FP | A.T.S. Applicazione Tecnologie Speciali S.R.L. | OWB | Class II | 2019-08-20 |
| K191645 | SKR 4000 | Konica Minolta, Inc. | MQB | Class II | 2019-08-16 |
| K191504 | PowerDR | Radiology Information Systems, Inc. | JAA | Class II | 2019-08-16 |
| K191922 | ACUSON P200 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | IYN | Class II | 2019-08-15 |
| K191582 | Cartesion Prime | Canon Medical Systems Corporation | KPS | Class II | 2019-08-13 |
| K183182 | Critical Care Suite | Ge Medical Systems, LLC | QFM | Class II | 2019-08-12 |
| K191792 | Versana Balance | GE Medical Systems Ultrasound and Primary Care Diagnostics | IYN | Class II | 2019-08-09 |
| K191884 | DR 100s | Agfa N.V. | IZL | Class II | 2019-08-09 |
| K191798 | Versana Active | GE Medical Systems Ultrasound and Primary Care Diagnostics | IYN | Class II | 2019-08-09 |
| K191233 | ARIETTA 750 | Hitachi Healthcare Americas | IYN | Class II | 2019-08-09 |
14,721 clearances in the Radiology panel. Data: openFDA.