Review Panel
Radiology FDA 510(k) Clearances & Devices
- Cleared Devices
- 14,721
- Product Codes (page)
- 28
- Latest Decision
- 2018-07-16
Clearances · page 36 of 148
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K181016 | Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System | Welch Allyn, Inc. | NFJ | Class II | 2018-07-16 |
| K181565 | Aquarius 8600 Digital Radiography Sensor | Biokinemetrics, Inc. | MQB | Class II | 2018-07-13 |
| K173801 | Transcranial Doppler Ultrasound System | Shenzhen Delica Medical Equipment Co., Ltd. | IYN | Class II | 2018-07-11 |
| K173631 | Intelli-C | Nrt X-Ray A/S | OWB | Class II | 2018-07-11 |
| K173486 | NTU-USB Ultrasound USB Box | National Taiwan University | IYN | Class II | 2018-07-11 |
| K181697 | 16ch Foot/ Ankle SPEEDER | Quality Electrodynamics, LLC | MOS | Class II | 2018-07-11 |
| K180289 | 3D Bolus Software | 3D Bolus, Inc. | MUJ | Class II | 2018-07-10 |
| K180970 | Disposable guides KDNG00 | Koelis | ITX | Class II | 2018-07-10 |
| K173274 | Ceevra Reveal 2.0 | Ceevra, Inc. | LLZ | Class II | 2018-07-10 |
| K181574 | Uscan | EchoNous, Inc. | IYO | Class II | 2018-07-10 |
| K180697 | Pseudo-Patient | Rtsafe, Inc. | IYE | Class II | 2018-07-10 |
| K181572 | Workflow Box | Mirada Medical, Ltd. | QKB | Class II | 2018-07-10 |
| K181547 | FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) | Echosens | IYO | Class II | 2018-07-09 |
| K180515 | GammaTile | Isoray Medical, Inc. | KXK | Class II | 2018-07-06 |
| K181526 | XRpad2 4343 HWC-M Flat Panel Detector | Varex Imaging Corporation | MQB | Class II | 2018-07-03 |
| K180021 | Proton Positioing and Immobilization Devices | Medtec Inc Dba Civco Medical Solutions and Civco Radiotherap | IYE | Class II | 2018-06-29 |
| K181404 | Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf Collimator | Varian Medical Systems, Inc. | IYE | Class II | 2018-06-28 |
| K180858 | CALLISTO eye | Carl Zeiss Meditec, AG | NFJ | Class II | 2018-06-27 |
| K181413 | uDR 592h, uDR 596i | Shanghai United Imaging Healthcare Co., Ltd. | KPR | Class II | 2018-06-27 |
| K173574 | DenSeeMammo | Statlife | LLZ | Class II | 2018-06-26 |
| K181465 | SpaceOAR System | Augmenix, Inc. | OVB | Class II | 2018-06-25 |
| K180995 | Vscan Extend | GE Medical Systems Ultrasound and Primary Care Diagnostics | IYN | Class II | 2018-06-25 |
| K173595 | Shear Wave Quantificational Ultrasound Diagnostic System | Wuxi Hisky Medical Technologies Co., Ltd. | IYO | Class II | 2018-06-22 |
| K180815 | MIM - SPECTRA Quant | Mim Software, Inc. | LLZ | Class II | 2018-06-22 |
| K180809 | Eclipse II | Carestream Health, Inc. | MQB | Class II | 2018-06-21 |
| K172346 | sterEOS Workstation | Eos Imaging | LLZ | Class II | 2018-06-19 |
| K181290 | Fusion Bx 2.0 | Focal Healthcare, Inc. | LLZ | Class II | 2018-06-15 |
| K173507 | Prodiva 1.5T CX and Prodiva 1.5T CS R5.4 | Philips Healthcare (Suzhou) Co., Ltd. | LNH | Class II | 2018-06-15 |
| K173780 | EchoMD Automated Ejection Fraction Software | Bay Labs, Inc. | LLZ | Class II | 2018-06-14 |
| K180100 | MRIaudio PREM System | Mriaudio | LNH | Class II | 2018-06-14 |
| K181279 | Ysio Max | Siemens Medi Cal Solutions, Inc. | KPR | Class II | 2018-06-13 |
| K180989 | PEDRA-17F Digital Flat Panel X-ray Detector | Radisen, Inc. | MQB | Class II | 2018-06-13 |
| K172983 | HealthCCS | Zebra Medical Vision, Ltd. | JAK | Class II | 2018-06-13 |
| K181363 | EcoVue Sterile and Non-Sterile Ultrasound Gels | H R Pharmaceuticals, Inc. | MUI | Class II | 2018-06-13 |
| K181093 | SyMRI | Syntheticmr AB | LNH | Class II | 2018-06-12 |
| K181343 | HeartSee Cardiac P.E.T. Processing Software | Bracco Diagnostics, Inc. | KPS | Class II | 2018-06-12 |
| K172961 | LIAC HWL | Sit Sordina Iort Technologies Spa | IYE | Class II | 2018-06-11 |
| K180332 | 17HK700G-W | Lg Electronics | MQB | Class II | 2018-06-08 |
| K181264 | QLAB Advanced Quantification Software | Philips Ultrasound, Inc. | LLZ | Class II | 2018-06-07 |
| K180947 | Orthopantomograph OP 3D | Palodex Group OY | OAS | Class II | 2018-06-07 |
| K180926 | uMR 560 | Shanghai United Imaging Healthcare Co., Ltd. | LNH | Class II | 2018-06-06 |
| K180925 | uMR 570 | Shanghai United Imaging Healthcare Co., Ltd. | LNH | Class II | 2018-06-06 |
| K173821 | LungQ Software | Thirona Corporation | JAK | Class II | 2018-06-05 |
| K181177 | Interventional Workspot | Philips Medical Systems Nederland B.V. | LLZ | Class II | 2018-05-31 |
| K181098 | ACUSON SC2000 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | IYN | Class II | 2018-05-31 |
| K180572 | AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10 | Supersonic Imagine | IYN | Class II | 2018-05-29 |
| K180976 | PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels | Pixxgen Corporation | MQB | Class II | 2018-05-24 |
| K180862 | Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound System | Edan Instruments, Inc. | IYN | Class II | 2018-05-24 |
| K181080 | McKesson Cardiology | Change Healthcare Israel , Ltd. | LLZ | Class II | 2018-05-24 |
| DEN180005 | OsteoDetect | Imagen Technologies, Inc. | QBS | Class II | 2018-05-24 |
| K181136 | CS 9600 | Trophy | OAS | Class II | 2018-05-24 |
| K180543 | GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85 | Samsung Electronics Co., Ltd. | KPR | Class II | 2018-05-24 |
| K180811 | Biograph Vision | Siemens Medical Solutions USA, Inc. | KPS | Class II | 2018-05-23 |
| K180455 | NeuralBot | Neural Analytics, Inc. | IYN | Class II | 2018-05-22 |
| K173395 | MECALL CLISIS SYSTEMS, Discovery RF180 | General Medical Merate S.P.A | JAA | Class II | 2018-05-21 |
| K181145 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | MUJ | Class II | 2018-05-18 |
| K180663 | LaVid FMTS DIAGNOSTIC X-RAY SYSTEM | Livermoretech, Inc. | KPR | Class II | 2018-05-18 |
| K172675 | Varian Cervical Sleeves | Varian Medical Systems, Inc. | JAQ | Class II | 2018-05-16 |
| K180901 | Low Dose CT Lung Cancer Screening Option | Hitachi Healthcare Americas | JAK | Class II | 2018-05-16 |
| K180883 | 5D Viewer | Samsung Medison Co., Ltd. | LLZ | Class II | 2018-05-15 |
| K173940 | Astroid Planning App | .Decimal, LLC | MUJ | Class II | 2018-05-15 |
| K181003 | VIVIX-S 1717V | Vieworks Co., Ltd. | MQB | Class II | 2018-05-15 |
| K173576 | Pristina Serena | GE Healthcare | MUE | Class II | 2018-05-14 |
| K180799 | Clarius Ultrasound Scanner | Clarius Mobile Health Corp. | IYN | Class II | 2018-05-14 |
| K173810 | Ventripoint Medical System Plus (VMS+) | Ventripoint Diagnostics , Ltd. | IYN | Class II | 2018-05-14 |
| K180727 | LineUp | Curvebeam, LLC | JAK | Class II | 2018-05-11 |
| K180409 | HS40 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | 2018-05-11 |
| K180961 | RadiForce MX194 | Eizo Corporation | PGY | Class II | 2018-05-10 |
| K173309 | Faxitron VisionCT | Faxitron Bioptics, LLC | MWP | Class II | 2018-05-09 |
| K180461 | Navi e/Navi s/Navi X Diagnostic Ultrasound System | Shenzhen Wisonic Medical Technology Co. , Ltd. | IYN | Class II | 2018-05-09 |
| K181032 | Halcyon | Varian Medical Systems, Inc. | IYE | Class II | 2018-05-09 |
| K180641 | Invenia ABUS Viewer | GE Healthcare | LLZ | Class II | 2018-05-04 |
| K180019 | CAAS Workstation | Pie Medical Imaging BV | IZI | Class II | 2018-05-03 |
| K180599 | Venue | GE Medical Systems Ultrasound and Primary Care Diagnostics | IYN | Class II | 2018-05-02 |
| K180636 | ExactVu High Resolution Micro-Ultrasound System | Exact Imaging, Inc. | IYO | Class II | 2018-04-30 |
| K180069 | HDR MRI Lumen Marker | C4 Imaging, LLC | JAQ | Class II | 2018-04-27 |
| K173390 | hipEOS | Onefit Medical | LLZ | Class II | 2018-04-27 |
| K180514 | VERITON NM | Spectrum Dynamics Medical, Ltd. | KPS | Class II | 2018-04-25 |
| K180563 | syngo.plaza | Siemens Healthcare GmbH | LLZ | Class II | 2018-04-25 |
| K180379 | RayStation 7 | RaySearch Laboratories AB (PUBL) | MUJ | Class II | 2018-04-25 |
| K162314 | IMACTIS CT-Navigation system | Imactis, Sas | JAK | Class II | 2018-04-24 |
| K180225 | GSI Viewer with GSI Fat Option | GE Medical Systems SCS | JAK | Class II | 2018-04-24 |
| K173865 | trophon2 | Nanosonics Limited | OUJ | Class II | 2018-04-24 |
| K172768 | ZOOM | Zetta Medical Technologies, LLC | LLZ | Class II | 2018-04-24 |
| K173962 | Viamo c100 TUS-VC100 Diagnostic Ultrasound System | Toshibamedical Systems Corporation | IYN | Class II | 2018-04-20 |
| K180161 | Viz CTP | Viz. Ai, Inc. | LLZ | Class II | 2018-04-20 |
| K180765 | Televere Podiatry X-Ray System HF | Televere Systems, Inc. | KPR | Class II | 2018-04-20 |
| K180782 | Aria | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | KGI | Class II | 2018-04-20 |
| K172477 | iSchemaView RAPID | Ischemaview, Inc. | LLZ | Class II | 2018-04-19 |
| K180336 | syngo.MR Applications | Siemens Medical Solutions USA, Inc. | LLZ | Class II | 2018-04-19 |
| K173816 | NM/CT 850, NM/CT 860 | GE Healthcare | KPS | Class II | 2018-04-17 |
| K180704 | SonoSite iViz Ultrasound System | FUJIFILM Sonosite, Inc. | IYN | Class II | 2018-04-13 |
| K170761 | LIGHTSonic BUBM | Lightmed USA, Inc. | IYO | Class II | 2018-04-13 |
| K180667 | SmartGrid | Carestream Health, Inc. | MQB | Class II | 2018-04-13 |
| K172143 | uMI 780 PET/CT System | Shanghai United Imaging Healthcare Co., Ltd. | KPS | Class II | 2018-04-13 |
| K180408 | U60 Diagnostic Ultrasound System | Edan Instruments, Inc. | IYN | Class II | 2018-04-13 |
| K173632 | SOMATOM go.Up, SOMATOM go.Now, SOMATOM go.Top, SOMATOM go.All, Scan&GO | Siemens Medical Solutions USA, Inc. | JAK | Class II | 2018-04-13 |
| K162499 | Best Instruminal Applicator | Best Medical International, Inc. | JAQ | Class II | 2018-04-13 |
| K180651 | Uroview FD II | Pausch Medical GmbH | JAA | Class II | 2018-04-12 |
| K180666 | 48CH Head Coil | Ge Healthcare Coils (Usa Instruments, Inc.) | MOS | Class II | 2018-04-12 |
14,721 clearances in the Radiology panel. Data: openFDA.