Review Panel
Radiology FDA 510(k) Clearances & Devices
- Cleared Devices
- 14,721
- Product Codes (page)
- 29
- Latest Decision
- 2020-05-07
Clearances · page 29 of 148
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K200699 | HS70A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | 2020-05-07 |
| K193535 | EZER, Portable X-ray System | Livermoretech, Inc. | IZL | Class II | 2020-05-07 |
| K200435 | Catalyst+, Catalyst+ HD | C-Rad Positioning AB | IYE | Class II | 2020-05-07 |
| K201058 | Accuvue+ | Radmedix, LLC | MQB | Class II | 2020-05-06 |
| K200315 | Ziostation2 | Ziosoft, Inc. | LLZ | Class II | 2020-05-05 |
| K200546 | ZeeroMED View | O3 Enterprise Srl | LLZ | Class II | 2020-05-05 |
| K193176 | uMR 780 | Shanghai United Imaging Healthcare Co., Ltd. | LNH | Class II | 2020-05-05 |
| K193220 | AVIEW LCS | Coreline Soft Co., Ltd. | LLZ | Class II | 2020-05-05 |
| K201004 | Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat Panel Detector Model Name Mano4336W | Iray Technology Taicang , Ltd. | MQB | Class II | 2020-05-01 |
| K201012 | EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System | Philips Ultrasound, Inc. | IYN | Class II | 2020-05-01 |
| K200917 | Azurion R2.1 | Philips Medical Systems Nederland B.V. | OWB | Class II | 2020-05-01 |
| K192656 | Optimized Positioning System (OPS) Insight | Corin USA | LLZ | Class II | 2020-05-01 |
| K192405 | Image Guidance System for Radiotherapy | Jiangsu Rayer Medical Technology Co., Ltd. | IYE | Class II | 2020-05-01 |
| K193523 | ArthrexVIP Web Portal | Arthrex, Inc. | LLZ | Class II | 2020-04-30 |
| K200327 | Evry | Synaptive Medical, Inc. | LNH | Class II | 2020-04-29 |
| K193459 | Panther Stereotactic | Prowess, Inc. | MUJ | Class II | 2020-04-27 |
| K200074 | O-arm O2 Imaging System | Medtronic, Inc. | OWB | Class II | 2020-04-24 |
| K200787 | BSD3543W | Bontech Co., Ltd. | MQB | Class II | 2020-04-23 |
| K192475 | NemoFAB | Software Nemotec S.L. | LLZ | Class II | 2020-04-23 |
| K200585 | Acuson SC2000 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | IYN | Class II | 2020-04-22 |
| K193351 | NinesAI | Nines, Inc. | QAS | Class II | 2020-04-21 |
| K200600 | Sentinel | C-Rad Positioning AB | IYE | Class II | 2020-04-20 |
| K200024 | uMR 570 | Shanghai United Imaging Healthcare Co., Ltd. | LNH | Class II | 2020-04-20 |
| K200158 | LOGIQ E10 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | IYN | Class II | 2020-04-17 |
| K200733 | Opticross 35 15 MHz Peripheral Imaging Catheter | Boston Scientific Corporation | ITX | Class II | 2020-04-17 |
| K193326 | ARTIS Icono | Siemens Medical Solutions USA, Inc. | OWB | Class II | 2020-04-16 |
| K200755 | Caption Guidance | Caption Health | QJU | Class II | 2020-04-16 |
| K200707 | ACUSON Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | IYN | Class II | 2020-04-15 |
| K200887 | AS-10 | Canon, Inc. | OWB | Class II | 2020-04-15 |
| K193369 | Xelis Dental 2.0 | Infinitt Healthcare Co., Ltd. | LLZ | Class II | 2020-04-14 |
| K200703 | JiveX | Visus Health IT GmbH | LLZ | Class II | 2020-04-14 |
| K192167 | CuraRad-ICH | Curacloud Corp. | QAS | Class II | 2020-04-13 |
| K200726 | AcuityPDR | Radmedix, LLC | IZL | Class II | 2020-04-13 |
| K200668 | DR-ID 1200SDK System | Fujifilm Corporation | MQB | Class II | 2020-04-10 |
| K193282 | SIGNA Premier | Ge Healthcare (Ge Medical Systems, LLC) | LNH | Class II | 2020-04-10 |
| K193215 | Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR Systems | Philips Medical Systems Nederland B.V. | LNH | Class II | 2020-04-10 |
| K200644 | ACUSON Freestyle Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | IYN | Class II | 2020-04-10 |
| K200078 | VARO Plan | 3D Industrial Imaging Co., Ltd. | LLZ | Class II | 2020-04-10 |
| K200688 | hyperion X5, NewTom GO, X-RADiUS COMPACT | Cefla S.C. | OAS | Class II | 2020-04-09 |
| K193329 | PreXion3D Explorer EX | Prexion Corporation | OAS | Class II | 2020-04-09 |
| K200713 | EchoNavigator | Philips Medical Systems Nederland B.V. | LLZ | Class II | 2020-04-09 |
| K193640 | ClearCalc | Radformation, Inc. | MUJ | Class II | 2020-04-09 |
| K200001 | MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus ME7T Diagnostic Ultrasound System, MX8/ MX8T/ Vaus8/ ME8 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | Class II | 2020-04-09 |
| K200411 | Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | Class II | 2020-04-08 |
| K193300 | AIMI-Triage CXR PTX | Radlogics, Inc. | QFM | Class II | 2020-04-08 |
| K200282 | Orfit Aerial Couchtop | Orfit Industries NV | LHN | Class II | 2020-04-08 |
| K200477 | Flex Body Speeder | Quality Electrodynamics, LLC | MOS | Class II | 2020-04-08 |
| K193218 | Innovision Audio | Innovere Medical, Inc. | LNH | Class II | 2020-04-07 |
| K200339 | HS40 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | 2020-04-07 |
| K200608 | Eclipse Treatment Planning System v16.0 | Varian Medical Systems, Inc. | MUJ | Class II | 2020-04-03 |
| K200022 | FLUSION-9001, Fluoroscopic C-arm Mobile X-ray System | Livermoretech, Inc. | OWB | Class II | 2020-04-03 |
| K192176 | IntelePACS | Intelerad Medical Systems Incorporated | LLZ | Class II | 2020-04-02 |
| K200251 | Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | Class II | 2020-04-02 |
| K200119 | LOGIQ E10s | GE Medical Systems Ultrasound and Primary Care Diagnostics | IYN | Class II | 2020-04-01 |
| K192228 | CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectant | Cs Medical, LLC | PSW | Class II | 2020-04-01 |
| K200524 | SOMATOM X.cite, Scan&GO, SOMATOM go.Platform - go.Up, go.Now, go.Top, go.All, go. Sim, go. Open Pro, Scan&GO | Siemens Medical Solutions USA, Inc. | JAK | Class II | 2020-04-01 |
| K200622 | Focus 43C detector, TRIMAX 43C detector | Iray Technology Taicang , Ltd. | MQB | Class II | 2020-04-01 |
| K193087 | Rapid ICH | Ischemaview Incorporated | QAS | Class II | 2020-03-31 |
| K192852 | MRI ECG Patient Cable | Ivy Biomedical Systems, Inc. | LNH | Class II | 2020-03-28 |
| K200548 | CUBEScan BioCon-1100 | Mcube Technology Co., Ltd. | IYO | Class II | 2020-03-27 |
| K193200 | uMR Omega | Shanghai United Imaging Healthcare Co., Ltd. | LNH | Class II | 2020-03-27 |
| K193518 | KOSMOS | EchoNous, Inc. | IYN | Class II | 2020-03-26 |
| K200515 | syngo.CT Cardiac Planning | Siemens Medical Soultions USA, Inc. | JAK | Class II | 2020-03-25 |
| K192437 | Arterys MICA | Arterys, Inc. | QIH | Class II | 2020-03-25 |
| K192854 | MammoScreen | Therapixel | QDQ | Class II | 2020-03-25 |
| K200485 | RadiForce RX1270, RadiForce RX1270-AR | Eizo Corporation | PGY | Class II | 2020-03-23 |
| K193089 | MULTIX Impact | Siemens Medical Solutions USA, Inc. | KPR | Class II | 2020-03-20 |
| K193281 | Hepatic VCAR | GE Medical Systems SCS | JAK | Class II | 2020-03-20 |
| K200474 | Symbia 6.7 | Siemens Medical Solutions USA, Inc. | KPS | Class II | 2020-03-20 |
| K200418 | VIVIX-S VW | Vieworks Co., Ltd. | MQB | Class II | 2020-03-18 |
| K193658 | Viz ICH | Viz. Ai, Inc. | QAS | Class II | 2020-03-18 |
| K200136 | Shear Wave Quantificational Ultrasound Diagnostic System | Wuxi Hisky Medical Technologies Co., Ltd. | IYO | Class II | 2020-03-17 |
| K200385 | CONTINUUM PACS | Integrated Ophthalmic Systems, Inc. | NFJ | Class II | 2020-03-16 |
| K190767 | AnatomicAligner | The Methodist Hospital Research Institute D/B/A Houston | LLZ | Class II | 2020-03-16 |
| K193267 | Al-Rad Companion (Musculoskeletal) | Siemens Medical Solutions USA, Inc. | JAK | Class II | 2020-03-16 |
| K191705 | OptikView GUP2103CMI | The Linden Group Corp | PGY | Class II | 2020-03-16 |
| K192888 | EzOrtho | Ewoosoft Co., Ltd. | LLZ | Class II | 2020-03-13 |
| K192925 | 32HL512D | Lg Electronics.Inc | PGY | Class II | 2020-03-13 |
| K200183 | CS 9600 | Trophy | OAS | Class II | 2020-03-13 |
| K192388 | SonoVision Ultrasound Imaging System | Tissue Differentiation Intelligence, LLC | IYN | Class II | 2020-03-12 |
| K190978 | RefleXion Medical Radiotherapy System | Reflexion Medical, Inc. | IYE | Class II | 2020-03-12 |
| K192924 | MAGNETOM Vida, MAGNETOM Lumina, MAGNETOM Vida Fit | Siemens Medical Solutions USA, Inc. | LNH | Class II | 2020-03-11 |
| K193262 | DR 600 with Tomosynthesis | Agfa N.V. | IZF | Class II | 2020-03-09 |
| K193216 | syngo.CT Lung CAD | Siemens Medi Cal Solutions, Inc. | OEB | Class II | 2020-03-09 |
| K192574 | Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | LNH | Class II | 2020-03-09 |
| K200304 | EPIQ Diagnostic Ultrasound System | Philips Ultrasound, Inc. | IYN | Class II | 2020-03-06 |
| K200396 | Insight Enhanced DRF Digital Imaging System | Imaging Engineering, LLC | JAA | Class II | 2020-03-06 |
| K190993 | Kinepict Medical Imaging Tool version v2.2 | Kinepict Health, Ltd. | LLZ | Class II | 2020-03-05 |
| K192590 | CURA 778 | Fmi Medical Systems, Inc. | JAK | Class II | 2020-03-05 |
| K193139 | ProVecta 3D Prime Ceph | Durr Dental SE | OAS | Class II | 2020-03-05 |
| K200360 | TrackX | Track X Technology, LLC | OWB | Class II | 2020-03-05 |
| K193229 | Transpara | Screenpoint Medical B.V. | QDQ | Class II | 2020-03-05 |
| K191550 | Broncholab | Fluidda, Inc. | JAK | Class II | 2020-03-04 |
| K200275 | OVision Imaging System | Ophthalmic Labs, Inc. | NFJ | Class II | 2020-03-03 |
| K192506 | Vantage Galan 3T, MRT-3020, V6.0 | Canon Medical Systems Corporation | LNH | Class II | 2020-03-02 |
| K191928 | AccuContour | Xiamen Manteia Technology , Ltd. | QKB | Class II | 2020-02-28 |
| K191556 | Red Dot | Behold.Ai Technologies Limited | QFM | Class II | 2020-02-28 |
| K200221 | CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid Applicators (Henschke), HDR CT Compatible Split Ring Applicator, Segmented Vaginal Applicator, HDR Miami Applicator HDR Brachytherapy Applicator, 2/3 Endometrial Applicator Sets, CT HDR Ring & Tandem Applicator with Rectal Retractor | Mick Radio-Nuclear Instruments, Inc. | JAQ | Class II | 2020-02-28 |
| K192496 | Magnetom Sola, Magnetom Altea and Magnetom Sola Fit | Siemens Medical Solutions USA, Inc. | LNH | Class II | 2020-02-28 |
| K192962 | icobrain-ctp | Icometrix NV | LLZ | Class II | 2020-02-28 |
14,721 clearances in the Radiology panel. Data: openFDA.