Review Panel
Radiology FDA 510(k) Clearances & Devices
- Cleared Devices
- 14,721
- Product Codes (page)
- 27
- Latest Decision
- 2021-02-16
Clearances · page 26 of 148
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K200626 | VesselIQ Xpress | GE Medical Systems SCS | JAK | Class II | 2021-02-16 |
| K203312 | Vitrea Software Package, VSTP-001A | Canon Medical Systems Corporation | LLZ | Class II | 2021-02-16 |
| K203766 | 4D Integrated Treatment Console | Varian Medical Systems, Inc. | MUJ | Class II | 2021-02-12 |
| K203103 | Synapse 3D, Synapse 3D Base Tools v6.1 | Fujifilm Corporation | LLZ | Class II | 2021-02-09 |
| K201583 | SmartCT R1.0 | Philips Medical Systems Nederland B.V. | OWB | Class II | 2021-02-09 |
| K203290 | Bonelogic | Disior, Ltd. | LLZ | Class II | 2021-02-05 |
| K210053 | LVivo Software Application | Dia Imaging Analysis, Ltd. | QIH | Class II | 2021-02-05 |
| K210054 | Cios Spin | Siemens Medical Systems USA, Inc. | OWB | Class II | 2021-02-05 |
| K210055 | Cios Alpha | Siemens Medical Solutions USA, Inc. | OWB | Class II | 2021-02-05 |
| K203582 | QUIBIM Precision Prostate (qp-Prostate) | Quibim S.L. | LLZ | Class II | 2021-02-04 |
| K203553 | Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | LNH | Class II | 2021-02-02 |
| K203667 | EzRay M (Model: VMX-P300) | VATECH Co., Ltd. | IZL | Class II | 2021-02-02 |
| K201231 | CTxx85 CT Scanner | Analogic Corporation | JAK | Class II | 2021-02-02 |
| K203537 | Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems | Sedecal., Sa. | KPR | Class II | 2021-02-01 |
| K201411 | Visage Breast Density | Visage Imaging GmbH | QIH | Class II | 2021-01-29 |
| K192650 | i_Space 1.5T Superconducting Magnetic Resonance Imaging System | Mri Division,Beijing Wandong Medical Technology Co., Ltd. | LNH | Class II | 2021-01-29 |
| K203849 | General Radiography CXDI-CS01 | Canon, Inc. | MQB | Class II | 2021-01-26 |
| K203104 | IBM iConnect Access | Merge Healthcare Incorporated | LLZ | Class II | 2021-01-26 |
| K202856 | Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3 Super, Acclarix AX25, Acclarix AX28, Acclarix AX2, Acclarix AX2 Exp, Acclarix AX2 Super, Acclarix AX15, Acclarix AX18, Acclarix LX3, Acclarix LX3 Exp, Acclarix LX3 Super, Acclarix LX25 and Acclarix LX28 | Edan Instruments, Inc. | IYN | Class II | 2021-01-25 |
| K202742 | Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory | Viasonix , Ltd. | IYN | Class II | 2021-01-25 |
| K203797 | vatech A9 (Model : PHT-30CSS) | VATECH Co., Ltd. | OAS | Class II | 2021-01-25 |
| K203010 | Platinum dRF Imaging System | Apelem-Dms Group | JAA | Class II | 2021-01-22 |
| K202391 | DIR 800 | Aesculap, Inc. | IZI | Class II | 2021-01-21 |
| K203719 | IntraSight Mobile | Volcano Corporation | IYO | Class II | 2021-01-19 |
| K203677 | ViewPoint 6 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | LLZ | Class II | 2021-01-15 |
| K193271 | uAI EasyTriage-Rib | Shanghai United Imaging Intelligence Co., Ltd. | QFM | Class II | 2021-01-15 |
| K202847 | AccuBrain | Brainnow Medical Technology Limited | LLZ | Class II | 2021-01-15 |
| K202767 | Vantage Orian 1.5T, MRT-1550, V6.0 | Canon Medical Systems Corporation | LNH | Class II | 2021-01-15 |
| K203142 | Veuron-Brain-pAb | Heuron Co., Ltd. | LLZ | Class II | 2021-01-15 |
| K202700 | ART-Plan | Therapanacea | QKB | Class II | 2021-01-14 |
| K203669 | Mobius3D | Varian Medical Systems, Inc. | IYE | Class II | 2021-01-14 |
| K203658 | Micro C Medical Imaging System, M01 | Oxos Medical, Inc. | IZL | Class II | 2021-01-12 |
| K203280 | Hepatica v1 (Hepatica v1.0.0) | Perspectum, Ltd. | LNH | Class II | 2021-01-12 |
| K201836 | Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i | Canon Medical Systems Corporation | JAK | Class II | 2021-01-12 |
| K203114 | LOGIQ P10, LOGIQ P9, LOGIQ P8 | GE Medical Systems Ultrasound and Primary Care Diagnostics | IYN | Class II | 2021-01-08 |
| K203345 | MULTIX Impact | Siemens Medical Solutions USA, Inc. | KPR | Class II | 2021-01-07 |
| K202414 | BrainInsight | Hyperfine Research, Inc. | LLZ | Class II | 2021-01-07 |
| K202350 | SR-1000 Portable DR Imaging System, SR-1000S Portable DR Imaging System | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) | IZL | Class II | 2021-01-06 |
| K203340 | MULTIX Impact C | Siemens Medical Solutions USA, Inc. | KPR | Class II | 2021-01-06 |
| K202267 | Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles | Isoray Medical, Inc. | KXK | Class II | 2020-12-31 |
| K202322 | Sim&Size | Sim&Cure | PZO | Class II | 2020-12-31 |
| K203137 | Venue Fit | GE Medical Systems Ultrasound and Primary Care Diagnostics | IYN | Class II | 2020-12-29 |
| K202455 | Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc MACH20 Ultrasonic Diagnostic Systems | Supersonic Imagine | IYN | Class II | 2020-12-29 |
| K203508 | BriefCase | Aidoc Medical , Ltd. | QAS | Class II | 2020-12-29 |
| K200965 | XR-MX/1000 | Karl Storz Endoscopy America, Inc. | JAA | Class II | 2020-12-29 |
| K200422 | Image Quality Analyzer (IQA) | Visionquest Biomedical, Inc. | NFJ | Class II | 2020-12-24 |
| K202882 | Affinity | Hermes Medical Solutions AB | KPS | Class II | 2020-12-23 |
| K202526 | OmniTom Elite | Neurologica Corporation, A Subsidiary of Samsung Electronics | JAK | Class II | 2020-12-23 |
| K202431 | ControlRad Select Model Z | Controlrad, Inc. | OWB | Class II | 2020-12-23 |
| K202353 | SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging System | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) | IZL | Class II | 2020-12-23 |
| K203281 | Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-X | Medphoton GmbH | OWB | Class II | 2020-12-22 |
| K203504 | Cios Flow | Siemens Medical Solutions USA, Inc. | OWB | Class II | 2020-12-22 |
| K202229 | AI Metrics | Ai Metrics, LLC | LLZ | Class II | 2020-12-22 |
| K201555 | EchoGo Pro | Ultromics, Ltd. | POK | Class II | 2020-12-18 |
| K203172 | MOSAIQ Oncology Information System | Elekta Solutions AB | IYE | Class II | 2020-12-18 |
| K202412 | ClearRT Helical kVCT for the Radixact Treatment Delivery System | Accuray Incorporated | IYE | Class II | 2020-12-18 |
| K203551 | Alphenix, INFX-8000V/B, /S, V9.1 | Canon Medical Systems Corporation | OWB | Class II | 2020-12-18 |
| K201250 | SQuEEZ Software | Cardiowise, Inc. | LLZ | Class II | 2020-12-18 |
| K200940 | BeamSite | Doseoptics, LLC | IYE | Class II | 2020-12-11 |
| K201745 | Deep Learning Image Reconstruction for Gemstone Spectral Imaging | Ge Medical Systems, LLC | JAK | Class II | 2020-12-10 |
| K203042 | Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-I | Canon Medical Systems Corporation | JAK | Class II | 2020-12-10 |
| K201039 | HepaFat-AI | Resonance Health Analysis Services Pty, Ltd. | LNH | Class II | 2020-12-07 |
| K203249 | Nucleus.io | Nucleushealth, LLC | LLZ | Class II | 2020-12-04 |
| K202487 | HealthJOINT | Zebra Medical Vision, Ltd. | LLZ | Class II | 2020-12-04 |
| K203087 | CombiDiagnost R90 | Philips Medical Systems Dmc GmbH | JAA | Class II | 2020-12-03 |
| K203053 | Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | LNH | Class II | 2020-12-02 |
| K200572 | Planmeca Romexis | Planmeca Oy | LLZ | Class II | 2020-12-02 |
| K203159 | Lux 35 Detector | Carestream Health | MQB | Class II | 2020-12-02 |
| K202388 | Apolo D / Apolo S | Vmi Tecnologias Ltda | KPR | Class II | 2020-12-01 |
| K203216 | The Multimodality Advanced Vessel Analysis | Philips Medical Systems Nederland B.V. | JAK | Class II | 2020-11-25 |
| K201825 | MiniCAT 2D | Xoran Technologies, LLC | KPR | Class II | 2020-11-20 |
| K193287 | CorInsights MRI | Adm Diagnostics, Inc. | LLZ | Class II | 2020-11-20 |
| K200873 | HALO | Nico-Lab B.V. | QAS | Class II | 2020-11-20 |
| K202035 | Vscan Air | GE Medical Systems Ultrasound and Primary Care Diagnostics | ITX | Class II | 2020-11-20 |
| K203156 | DTX Studio Clinic | Nobel Biocare AB | LLZ | Class II | 2020-11-20 |
| K202805 | Optimized Positioning System (OPS) Insight | Corin USA | LLZ | Class II | 2020-11-20 |
| K203169 | Revolution Ascend | Ge Healthcare Japan Corporation | JAK | Class II | 2020-11-20 |
| K202233 | Venue Go | GE Medical Systems Ultrasound and Primary Care Diagnostics | IYN | Class II | 2020-11-18 |
| K201195 | syngo.via MI Workflows, syngo MBF | Siemens Medical Solutions USA, Inc. | QIH | Class II | 2020-11-18 |
| K203287 | DBSWIN, VISTAEASY | Dürr Dental SE | LLZ | Class II | 2020-11-18 |
| K203187 | HiRise | Curvebeam, LLC | JAK | Class II | 2020-11-18 |
| K202713 | TrueView 100 Pro | Compai Healthcare (Shenzhen) Co.,Ltd | MWP | Class II | 2020-11-18 |
| K201019 | Genius AI Detection | Hologic, Inc. | QDQ | Class II | 2020-11-18 |
| K201382 | X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology) | De Gotzen S.R.L. | OAS | Class II | 2020-11-18 |
| K193306 | PROView | GE Medical Systems SCS | LLZ | Class II | 2020-11-17 |
| K202966 | SIGNA Architect | Ge Healthcare (Ge Medical Systems, LLC) | LNH | Class II | 2020-11-13 |
| K202132 | Venue | GE Medical Systems Ultrasound and Primary Care Diagnostics | IYN | Class II | 2020-11-13 |
| K203173 | ExacTrac Dynamic | Brainlab AG | IYE | Class II | 2020-11-12 |
| K193289 | FastStroke, CT Perfusion 4D | GE Medical Systems SCS | JAK | Class II | 2020-11-12 |
| K202074 | Apache Ultrasound System (Model C62) | Compal Electronics, Inc. | IYN | Class II | 2020-11-12 |
| K203106 | Nio Fusion 12MP (MDNC-12130) | Barco N.V. | PGY | Class II | 2020-11-10 |
| K203128 | EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2/EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2 PREMIER PLUS | Olympus Medical Systems Corp. | IYN | Class II | 2020-11-09 |
| K201990 | DC-30/DC-32/DC-28/DC-26/DC-25/DC-20/DC-30 Exp/DC-32 Exp Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | Class II | 2020-11-09 |
| K193562 | AI-Rad Companion Organs RT | Siemens Medical Solutions USA, Inc. | QKB | Class II | 2020-11-06 |
| K200750 | Neuro.Al Algorithm | Terarecon,Inc. | LLZ | Class II | 2020-11-06 |
| K202422 | Arietta 65 | Hitachi Healthcare Americas | IYN | Class II | 2020-11-04 |
| K200350 | MyHip Planner & Verifier | Medacta International S.A. | LLZ | Class II | 2020-11-04 |
| K202013 | WRDensity by Whiterabbit.ai | Whiterabbit.Ai, Inc. | QIH | Class II | 2020-10-30 |
| K202556 | HS30 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | 2020-10-30 |
| K201988 | T-Lite | Sonoscanner | IYN | Class II | 2020-10-30 |
14,721 clearances in the Radiology panel. Data: openFDA.