Review Panel
Radiology FDA 510(k) Clearances & Devices
- Cleared Devices
- 14,721
- Product Codes (page)
- 25
- Latest Decision
- 2020-02-28
Clearances · page 30 of 148
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K193243 | Alta Multipurpose Device | Qfix | IYE | Class II | 2020-02-28 |
| K200016 | uCT 530, uCT 550 | Shanghai United Imaging Healthcare Co., Ltd. | JAK | Class II | 2020-02-25 |
| K192253 | SonicEye Dual-Array Ultrasound System | Sonivate Medical, Inc. | IYO | Class II | 2020-02-25 |
| K200178 | Ez3D-i /E3 | Ewoosoft Co., Ltd. | LLZ | Class II | 2020-02-25 |
| K192832 | Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i | Canon Medical Systems Corporation | JAK | Class II | 2020-02-21 |
| K191646 | Beamscan MR | Ptw-Freiburg Physikalisch-Technische-Werkstaetten | IYE | Class II | 2020-02-21 |
| K192851 | OASIS MRI System | Hitachi Healthcare Americas | LNH | Class II | 2020-02-21 |
| K200161 | 3MP Monochrome Digital Mammography LCD Monitor MS-S300 | Jvckenwood Corporation | PGY | Class II | 2020-02-21 |
| K192922 | Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter | Gentuity, LLC | NQQ | Class II | 2020-02-20 |
| K192973 | densitas densityai | Densitas, Inc. | LLZ | Class II | 2020-02-19 |
| K200179 | Collaboration Live | Philips Health Care | LLZ | Class II | 2020-02-18 |
| K192894 | Vita Flex CR System with LLI | Carestream Health, Inc. | MQB | Class II | 2020-02-18 |
| K200132 | Ashvins | Medicalcommunications GmbH | LLZ | Class II | 2020-02-18 |
| K192923 | Vitrea Software Package | Canon Medical Systems Corporation | LLZ | Class II | 2020-02-14 |
| K193248 | Biograph Vision, Biograph mCT Family of PET/CTs | Siemens Medical Solutions USA, Inc. | KPS | Class II | 2020-02-14 |
| K193152 | Affinity | Hermes Medical Solutions AB | KPS | Class II | 2020-02-14 |
| K192372 | ASCEND Image Viewer | Ascend Hit | LLZ | Class II | 2020-02-14 |
| K193644 | E-COM DR-2000 DR | Livermoretech, Inc. | MQB | Class II | 2020-02-14 |
| K192277 | CardIQ Flow | GE Medical Systems SCS | KPS | Class II | 2020-02-14 |
| K193498 | Infinitt RT PACS | Infinitt Healthcare Co., Ltd. | LLZ | Class II | 2020-02-13 |
| K192828 | Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System | Canon Medical Systems Corporation | JAK | Class II | 2020-02-13 |
| K193178 | Biograph Horizon | Siemens Medical Solution USA, Inc. | KPS | Class II | 2020-02-12 |
| K191235 | Leltek Ultrasound Imaging System | Leltek, Inc. | IYN | Class II | 2020-02-12 |
| K192165 | Acteon Imaging Suite | De Gotzen S.R.L. | LLZ | Class II | 2020-02-11 |
| K192377 | Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon | Varian Medical Systems, Inc. | IYE | Class II | 2020-02-10 |
| K191347 | Paragon XHD Diagnostic Ultrasound System | Shenzhen Wisonic Medical Technology Co. , Ltd. | IYN | Class II | 2020-02-07 |
| DEN190040 | Caption Guidance | Bay Labs, Inc. | QJU | Class II | 2020-02-07 |
| K192002 | Lucy Point-of-Care Magnetic Resonance Imaging Device | Hyperfine Research, Inc. | LNH | Class II | 2020-02-06 |
| K193324 | Motion Correction System | Kineticor, Inc. | LNH | Class II | 2020-02-04 |
| K200050 | Akesis Galaxy RTx | Akesis, Inc. | IWB | Class II | 2020-02-04 |
| K192462 | syngo.MR Applications | Siemens Medical Solutions USA, Inc. | LLZ | Class II | 2020-01-31 |
| K193257 | ACUSON Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | IYN | Class II | 2020-01-31 |
| K200018 | HAD1717MC | H&Abyz | MQB | Class II | 2020-01-31 |
| K191539 | 1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support | Rapid Biomedical GmbH | MOS | Class II | 2020-01-31 |
| K193637 | MRH ALFA Radiographic System, MRH II Radiographic System, MRH IIE Radiographic System | Compania Mexicana DE Radiologia Cgr, S.A. DE C.V. | KPR | Class II | 2020-01-28 |
| K193510 | Terason uSmart3200T Ultrasound System | Teratech Corporation | IYN | Class II | 2020-01-28 |
| K193241 | Emission Computed Tomography System | Shanghai United Imaging Healthcare Co., Ltd. | KPS | Class II | 2020-01-26 |
| K193512 | THD Procto Software System | Thd Spa | IYO | Class II | 2020-01-26 |
| K193454 | IQon Spectral CT | Philips Medical Systems Nederland B.V. | JAK | Class II | 2020-01-24 |
| K193109 | MRCAT brain | Philips Medical Systems MR Finland | MUJ | Class II | 2020-01-24 |
| K193261 | FlightPlan for Embolization | GE Medical Systems SCS | LLZ | Class II | 2020-01-24 |
| K191014 | Elements Viewer | Brainlab AG | LLZ | Class II | 2020-01-23 |
| K190120 | VINNO 8, VINNO 6, VINNO 5 | Vinno Technology (Suzhou) Co.,Ltd | IYN | Class II | 2020-01-23 |
| K191821 | Blue Phantom PT | Iba Dosimetry GmbH | LHN | Class II | 2020-01-23 |
| K190839 | GammaTile | Gt Medical Technologies | KXK | Class II | 2020-01-23 |
| K192170 | VistaScan USB Ultrasound Imaging System | Emagine Solutions Technology, LLC | IYO | Class II | 2020-01-23 |
| K193574 | Q-Rad System | Carestream Health, Inc. | KPR | Class II | 2020-01-22 |
| K192098 | EzMobile | Ewoosoft Co., Ltd. | LLZ | Class II | 2020-01-20 |
| K192182 | C015 | Micronica Srl | OWB | Class II | 2020-01-17 |
| K192761 | Asimov-MKS Imaging System | Onlume, Inc. | IZI | Class II | 2020-01-17 |
| K192956 | Auto Positioning | Ge Hangwei Medical Systems Co., Ltd. | JAK | Class II | 2020-01-16 |
| K191125 | ADAS 3D | Galgo Medical S.L | LLZ | Class II | 2020-01-15 |
| K193225 | KDR AU-DDR System Advanced U-Arm with Dynamic Digital Radiography, KDR AU System Advanced U-Arm with Static Digital Radiography | Konica Minolta Healthcare Americas, Inc. | KPR | Class II | 2020-01-15 |
| K192903 | RS85 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | 2020-01-06 |
| K193102 | MRIaudio PREM System with MRIview | Mriaudio, Inc. | LNH | Class II | 2020-01-06 |
| K192917 | ViewPoint 6 | Ge Medical Systems Ultrasound And | LLZ | Class II | 2020-01-06 |
| K193140 | Flex Body SPEEDER | Quality Electrodynamics, LLC | MOS | Class II | 2020-01-03 |
| K193431 | AlignRT Plus | Vision Rt, Ltd. | IYE | Class II | 2020-01-03 |
| K193360 | Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard | Radmedix, LLC | KPR | Class II | 2020-01-02 |
| K193381 | RadCalc Software | Lifeline Software, Inc. | MUJ | Class II | 2019-12-31 |
| K192912 | AutoMIStar | Apollo Medical Imaging Technology Pty. , Ltd. | LLZ | Class II | 2019-12-31 |
| K193403 | UroNav System | Invivo Corporation | LLZ | Class II | 2019-12-27 |
| K192939 | Volumetric Specimen Imager | Clarix Imaging | MWP | Class II | 2019-12-27 |
| K192196 | Medical Radiation Dosimetry System microSTARii | Landauer | IYE | Class II | 2019-12-27 |
| K193149 | True 3D Viewer Software | Echopixel, Inc. | LLZ | Class II | 2019-12-27 |
| K192383 | BriefCase | Aidoc Medical , Ltd. | QAS | Class II | 2019-12-20 |
| K193116 | MRopen EVO | Asg Superconductors S.P.A. | LNH | Class II | 2019-12-20 |
| K191879 | DRX-Evolution with Carestream Digital Tomosynthesis | Carestream Health, Inc. | KPR | Class II | 2019-12-20 |
| K192040 | AVIEW Modeler | Coreline Soft Co., Ltd. | LLZ | Class II | 2019-12-20 |
| K193230 | Ziehm Vision FD | Ziehm Imaging GmbH | OWB | Class II | 2019-12-20 |
| K191647 | QLAB Advanced Quantification Software | Philips Health Care | QIH | Class II | 2019-12-20 |
| K193238 | Nexus DR Digital X-Ray Imaging System (with vSharp) | Varex Imaging Corporation | MQB | Class II | 2019-12-20 |
| K183144 | uMC 560i | Shanghai United Imaging Healthcare Co., Ltd. | OWB | Class II | 2019-12-19 |
| K183676 | DentiqAir | 3D Industrial Imaging Co., Ltd. | LLZ | Class II | 2019-12-19 |
| K192410 | ZS3 and z.one pro Ultrasound Systems | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | Class II | 2019-12-19 |
| K192763 | syngo.CT CaScoring | Siemens Medical Solutions USA, Inc. | JAK | Class II | 2019-12-17 |
| K193170 | Deep Learning Image Reconstruction | Ge Healthcare Japan Corporation | JAK | Class II | 2019-12-13 |
| K192531 | QyScore Software | Qynapse | LLZ | Class II | 2019-12-13 |
| K192130 | Icobrain | Icometrix NV | LLZ | Class II | 2019-12-13 |
| K193317 | CoreLite X-Ray Specimen Cabinet | Cirdan Imaging Limited | MWP | Class II | 2019-12-13 |
| K193173 | CareView 1800Le | Careray Digital Medical System Co., Ltd. | MQB | Class II | 2019-12-13 |
| K192152 | DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | Class II | 2019-12-13 |
| K192554 | decimal3D | .Decimal, LLC | MUJ | Class II | 2019-12-13 |
| K192505 | HS50/HS60 Diagnostics Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | 2019-12-12 |
| K192571 | NemoScan | Software Nemotec S.L. | LLZ | Class II | 2019-12-11 |
| K192319 | HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | 2019-12-10 |
| K192287 | Transpara | Screenpoint Medical B.V. | QDQ | Class II | 2019-12-10 |
| K192279 | PhantomMSK Trauma | OrthoGrid Systems, Inc. | LLZ | Class II | 2019-12-07 |
| K192482 | Elekta Unity | Elekta Limited | IYE | Class II | 2019-12-05 |
| K191804 | TOMi Scope | Photonicare, Inc. | QJG | Class II | 2019-12-05 |
| K191864 | 21HK512D | Lg Electronics.Inc | PGY | Class II | 2019-12-05 |
| K192348 | SICAT Implant V2.0 | Sicat GmbH & Co. KG | LLZ | Class II | 2019-12-04 |
| K192038 | Emprint Visualization Application | Covidien, LLC | LLZ | Class II | 2019-12-02 |
| K191032 | fMRI Hardware System | Nordicneurolab AS | LNH | Class II | 2019-11-27 |
| K192791 | Diagnostic Ultrasound System | Edan Instruments, Inc. | IYO | Class II | 2019-11-27 |
| K192079 | EOSedge | Eos Imaging | KPR | Class II | 2019-11-27 |
| K192320 | HealthCXR | Zebra Medical Vision, Ltd. | QFM | Class II | 2019-11-26 |
| K192242 | Synergy Platform, Synergy, Infinity, VersaHD | Elekta Limited | IYE | Class II | 2019-11-22 |
| K192508 | Medsynapse Ris Pacs & Medsynapse VNA | Medsynaptic Private, Ltd. | LLZ | Class II | 2019-11-22 |
| K193031 | EXPD 4343P, EXPD 3643P | DRTECH Corporation | MQB | Class II | 2019-11-22 |
14,721 clearances in the Radiology panel. Data: openFDA.