Review Panel
Radiology FDA 510(k) Clearances & Devices
- Cleared Devices
- 14,721
- Product Codes (page)
- 27
- Latest Decision
- 2022-10-25
Clearances · page 19 of 148
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K222365 | Leltek Ultrasound Imaging System (Model: LU700 Series) | Leltek, Inc. | IYN | Class II | 2022-10-25 |
| K222470 | 3Dicom MD | Singular Health Pty, Ltd. | LLZ | Class II | 2022-10-25 |
| K223042 | Viz LVO ContaCT | Viz. Ai, Inc. | QAS | Class II | 2022-10-21 |
| K213128 | IntraOp VSP Software Device | Xironetic, LLC | LLZ | Class II | 2022-10-21 |
| K222361 | AI-Rad Companion (Musculoskeletal) | Siemens Medical Solutions USA, Inc. | JAK | Class II | 2022-10-20 |
| K222886 | Mercu 1717V | Iray Technology Taicang , Ltd. | MQB | Class II | 2022-10-20 |
| K221632 | Spine CAMP | Medical Metrics, Inc. | QIH | Class II | 2022-10-18 |
| K222855 | Digital Radiography CXDI-Pro, Digital Radiography D1 | Canon, Inc. | MQB | Class II | 2022-10-17 |
| K222407 | 16ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T 16ch Breast Coil, 1.5T 16ch Breast Coil, 3T 16ch Breast Coil | Neocoil, LLC | MOS | Class II | 2022-10-14 |
| K222662 | Vitrea CT Cardiac Analysis | Canon Medical Informatics, Inc. | LLZ | Class II | 2022-10-14 |
| K221093 | X-CUBE 70, X-CUBE 90 | Alpinion Medical Systems Co., Ltd. | IYN | Class II | 2022-10-14 |
| K221305 | AI-Rad Companion Organs RT | Siemens Medical Solutions USA, Inc. | QKB | Class II | 2022-10-14 |
| K221501 | syngo.via View&GO | Siemens Healthcare GmbH | LLZ | Class II | 2022-10-14 |
| K211321 | Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL) | Guangzhou Sonostar Technologies Co., Ltd. | IYN | Class II | 2022-10-13 |
| K220857 | X-CUBE 50, X-CUBE 60 | Alpinion Medical Systems Co., Ltd. | IYN | Class II | 2022-10-13 |
| K220169 | SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SonoFinder Wireless Probe Type Ultrasound Scanner (Model: SF14L25) | Bionet Co., Ltd. | IYN | Class II | 2022-10-11 |
| K220256 | MIM-Ablation | Mim Software, Inc. | QTZ | Class II | 2022-10-07 |
| K220709 | BriefCase | Aidoc Medical , Ltd. | QAS | Class II | 2022-10-07 |
| K222080 | Garion Image-Intensified Fluoroscopic X-Ray System, Mobile | Sg Healthcare Co, Ltd. | OWB | Class II | 2022-10-06 |
| K221449 | Genius AI Detection 2.0 | Hologic, Inc. | QDQ | Class II | 2022-10-06 |
| K211611 | QIR Suite | Casis Cardiac Simulation & Imaging Software | QIH | Class II | 2022-09-30 |
| K222625 | Shield System | Radiaction , Ltd. | OWB | Class II | 2022-09-30 |
| K222339 | uDR 380i Pro | Shanghai United Imaging Healthcare Co., Ltd. | IZL | Class II | 2022-09-30 |
| K220758 | e-Ortho Shoulder Software v1.1 | FH Industrie | LLZ | Class II | 2022-09-30 |
| K222353 | GM85 | Samsung Electronics Co., Ltd. | IZL | Class II | 2022-09-29 |
| K222687 | Digital Radiography CXDI-Elite, Digital Radiography E1 | Canon, Inc. | MQB | Class II | 2022-09-29 |
| K221300 | Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI, Consona NT, Nuewa N9, Recho N9, Consona N9 Exp, Consona N9 Elite, Resona N9, Consona N9T, Consona N8, Consona N8 Pro, Consona N8 Super, Consona OR, Consona N8S, Consona OI, Consona OT, Consona N8 Exp, Consona N8 Elite, Consona N8T, Consona N7, Consona N7 Pro, Consona N7 Super, Consona VR, Consona N7S, Consona VI, Consona VT, Consona N7 Exp, Consona N7 Elite, Consona N7T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | Class II | 2022-09-29 |
| K221496 | Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S, Consona AE, Consona AT, Consona N6 Exp Diagnostic Ultrasound System, Consona N6 Elite, Consona N6T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | Class II | 2022-09-29 |
| K220080 | CogNet QmTRIAGE | Medcognetics, Inc. | QFM | Class II | 2022-09-29 |
| K222329 | BriefCase | Aidoc Medical , Ltd. | QAS | Class II | 2022-09-28 |
| K222648 | 5000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500 P, Ultrasound System 5500 W, Ultrasound System 5500 CV, Ultrasound System 5300 G, Ultrasound System 5300 P, Ultrasound System 5300 W) | Philips Ultrasound, LLC | IYN | Class II | 2022-09-27 |
| K222661 | Digital Radiography CXDI-CS01 | Canon, Inc. | MQB | Class II | 2022-09-27 |
| K221738 | NS-HGlio | Neosoma, Inc. | QIH | Class II | 2022-09-27 |
| K220342 | XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3 | Canon Medical Systems Corporation | OWB | Class II | 2022-09-27 |
| K222655 | OtoSight Middle Ear Scope | Photonicare, Inc. | QJG | Class II | 2022-09-26 |
| K213759 | XACT Robotic System, ACE Model | Xact Robotics, Ltd. | JAK | Class II | 2022-09-23 |
| K213353 | Aorta-CAD | Imagen Technologies, Inc. | MYN | Class II | 2022-09-20 |
| K222121 | C630G LCD monitor, JUSHA-C630G LCD monitor, C630 LCD monitor, JUSHA-C630 LCD monitor | Nanjing Jusha Display Technology Co., Ltd. | PGY | Class II | 2022-09-19 |
| K221089 | P12 Elite Series Digital Color Doppler Ultrasound System | Sonoscape Medical Corp. | IYN | Class II | 2022-09-15 |
| K221797 | BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes and Length Assessment Device | Varian Medical Systems, Inc. | JAQ | Class II | 2022-09-14 |
| K220239 | Solid State X-ray Imager(Model: FXRD-4386WB) | Vieworks Co., Ltd. | MQB | Class II | 2022-09-13 |
| K221140 | P20 Elite Series Digital Color Doppler Ultrasound System | Sonoscape Medical Corp. | IYN | Class II | 2022-09-13 |
| K221417 | CLAROX plus (Model: VX-100) | Vsi Co., Ltd. | IZL | Class II | 2022-09-13 |
| K221733 | MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola Fit | Siemens Medical Solutions USA, Inc. | LNH | Class II | 2022-09-13 |
| K220986 | Aquilion Precision (TSX-304A/4) V10.10 with AiCE | Canon Medical Systems Corporation | JAK | Class II | 2022-09-12 |
| K221456 | Rapid ICH | Ischemaview, Inc. | QAS | Class II | 2022-09-12 |
| K221568 | KOLO Evolution XHD Series Ultrasound Diagnostic System | Kolo Medical (Suzhou) Co., Ltd. | IYN | Class II | 2022-09-12 |
| K222076 | EFAI ChestSuite XR Pleural Effusion Assessment System | Ever Fortune.Ai, Co., Ltd. | QFM | Class II | 2022-09-08 |
| K220783 | syngo.via RT Image Suite | Siemens Medical Solutions USA, Inc. | MUJ | Class II | 2022-09-07 |
| K213960 | LiverMultiScan v5 (LMSv5) | Perspectum | LNH | Class II | 2022-09-06 |
| K222069 | Ez3D-i/E3 | Ewoosoft Co., Ltd. | LLZ | Class II | 2022-09-06 |
| K221932 | Omni Legend | GE Healthcare | KPS | Class II | 2022-09-02 |
| K221241 | DrAid for Radiology v1 | Vinbrain Joint Stock Company | QFM | Class II | 2022-09-01 |
| K222387 | Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | LNH | Class II | 2022-08-31 |
| K222325 | 8ch Wrist Coil | Invivo Corporation (Business Trade Name: Philips) | MOS | Class II | 2022-08-31 |
| K220933 | QT Scanner 2000 Model A | Qt Imaging, Inc. | IYO | Class II | 2022-08-31 |
| K221999 | Ultrasound Transmission Gels | Hony Medical Co., Ltd. | MUI | Class II | 2022-08-30 |
| K221785 | TCL3 Motion Tracking System | Tracinnovations A/S | LNH | Class II | 2022-08-29 |
| K221100 | Viz RV/LV | Viz. Ai, Inc. | QIH | Class II | 2022-08-29 |
| K222277 | BriefCase | Aidoc Medical , Ltd. | QAS | Class II | 2022-08-26 |
| K211841 | MRI Planner | Spectronic Medical AB | MUJ | Class II | 2022-08-25 |
| K220598 | AutoContour Model RADAC V2 | Radformation, Inc. | QKB | Class II | 2022-08-24 |
| K220583 | ClearCheck Model RADCC V2 | Radformation, Inc. | IYE | Class II | 2022-08-23 |
| K222257 | 1.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil | Invivo Corporation (Business Trade Name: Philips) | MOS | Class II | 2022-08-23 |
| K221599 | HS40 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | 2022-08-22 |
| K220582 | ClearCalc Model RADCA V2 | Radformation, Inc. | MUJ | Class II | 2022-08-22 |
| K222172 | MI View&GO | Siemens Medical Solutions USA, Inc. | QIH | Class II | 2022-08-19 |
| K213520 | AXIR-CX | Radisen Co., Ltd. | LLZ | Class II | 2022-08-19 |
| K220903 | WebCeph | Assemblecircle Corp. | LLZ | Class II | 2022-08-17 |
| K220433 | syngo Application Software (VE21) | Siemens Medical Solution USA, Inc. | LLZ | Class II | 2022-08-16 |
| K221190 | ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | IYN | Class II | 2022-08-16 |
| K213527 | FORUM | Carl Zeiss Meditec, AG | NFJ | Class II | 2022-08-15 |
| K222145 | EzDent-i / E2 / Prora View/ Smart M Viewer | Ewoosoft Co., Ltd. | LLZ | Class II | 2022-08-12 |
| K220349 | TeraRecon Neuro | Terarecon,Inc. | LLZ | Class II | 2022-08-12 |
| K220910 | Medical image processing software | Hangzhou Deepwise & League of PHD Technology Co., Ltd. | JAK | Class II | 2022-08-11 |
| K213713 | AI-Rad Companion (Pulmonary) | Siemens Healthcare GmbH | JAK | Class II | 2022-08-11 |
| K213735 | dS Sentinelle Breast 16ch 1.5T Coil | Invivo Corporation (Business Trade Name: Philips) | MOS | Class II | 2022-08-08 |
| K213727 | dS Sentinelle Breast 16ch 3.0T Coil | Invivo Corporation (Business Trade Name: Philips) | MOS | Class II | 2022-08-08 |
| K222072 | Dolphin Imaging 12.0 | Patterson Dental Supply, Inc. | LLZ | Class II | 2022-08-08 |
| K213645 | ClearPoint Maestro Brain Model | ClearPoint Neuro, Inc. | QIH | Class II | 2022-08-08 |
| K221405 | Neurophet SCALE PET | Neurophet., Inc. | LLZ | Class II | 2022-08-05 |
| K221347 | Transpara 1.7.2 | Screenpoint Medical B.V. | QDQ | Class II | 2022-08-03 |
| K221432 | Customize | 3D-Side S.A. | QIH | Class II | 2022-08-03 |
| K221549 | X-ray Flat Panel Detectors (CareView 1800 RF) | Careray Digital Medical Technology Co., Ltd. | MQB | Class II | 2022-08-01 |
| K220961 | Deep Learning Image Reconstruction | Ge Healthcare Japan Corporation | JAK | Class II | 2022-07-29 |
| K213760 | ABMD Software | HeartLung Corporation | KGI | Class II | 2022-07-29 |
| K213998 | cvi42 Auto Imaging Software Application | Circle Cardiovascular Imaging, Inc. | QIH | Class II | 2022-07-28 |
| K221922 | Trinias | Shimadzu Corporation Medical Systems Division | OWB | Class II | 2022-07-28 |
| K221230 | TRON | Xoran Technologies, LLC | OWB | Class II | 2022-07-28 |
| K221923 | Swoop Portable MR Imaging System | Hyperfine, Inc. | LNH | Class II | 2022-07-28 |
| K221853 | OTC DDR | Konica Minolta Healthcare Americas, Inc. | KPR | Class II | 2022-07-27 |
| K221567 | LCD monitor (HMD3C21S), LCD monitor (HMD5G21S) | Qingdao Hisense Medical Equipment Co., Ltd. | PGY | Class II | 2022-07-26 |
| K220439 | Viz SDH | Viz. Ai, Inc. | QAS | Class II | 2022-07-25 |
| K220624 | AI4CMR v1.0 | Ai4medimaging Medical Solutions S.A. | LLZ | Class II | 2022-07-22 |
| K220882 | Vivid E80, Vivid E90, Vivid E95 | Ge Medical Systems Ultrasound And | IYN | Class II | 2022-07-22 |
| K221394 | 14HQ701G-B | Lg Electronics.Inc | MQB | Class II | 2022-07-22 |
| K221525 | PreXion3D Explorer PRO | Prexion Corporation | OAS | Class II | 2022-07-22 |
| K221461 | 10HQ701G-B | Lg Electronics.Inc | MQB | Class II | 2022-07-22 |
| K213922 | FX SPS | Pixee Medical | LLZ | Class II | 2022-07-22 |
| K220940 | EchoPAC Software Only, EchoPAC Plug-in | GE Medical Systems Ultrasound and Primary Care Diagnostics | QIH | Class II | 2022-07-22 |
14,721 clearances in the Radiology panel. Data: openFDA.