Review Panel
Radiology FDA 510(k) Clearances & Devices
- Cleared Devices
- 14,721
- Product Codes (page)
- 25
- Latest Decision
- 2022-07-20
Clearances · page 20 of 148
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K220039 | AutoSeg | Ai Medic, Inc. | LLZ | Class II | 2022-07-20 |
| K220956 | Libby Echo:Prio | Dyad Medical, Inc. | QIH | Class II | 2022-07-20 |
| K221512 | Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW) | Vieworks Co., Ltd. | MQB | Class II | 2022-07-20 |
| K221516 | ARTIS icono (Ceiling Configuration) | Siemens Medical Solutions USA, Inc. | OWB | Class II | 2022-07-19 |
| K220815 | BrainInsight | Hyperfine, Inc. | QIH | Class II | 2022-07-19 |
| K221803 | PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress. | Sedecal., Sa. | IZL | Class II | 2022-07-18 |
| K211720 | Planmed Clarity 2D, Planmed Clarify S | Planmed OY | MUE | Class II | 2022-07-18 |
| K221147 | Vivid T8, Vivid T9 | GE Medical Systems Ultrasound and Primary Care Diagnostics | IYN | Class II | 2022-07-18 |
| K221148 | Vivid iq | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | IYN | Class II | 2022-07-18 |
| K221876 | Digital Radiography CXDI-Pro, Digital Radiography D1 | Canon, Inc. | MQB | Class II | 2022-07-15 |
| K220619 | Vivid S60N, Vivid S70N | GE Medical Systems Ultrasound and Primary Care Diagnostics | IYN | Class II | 2022-07-15 |
| K221727 | syngo.CT Extended Functionality | Siemens Medical Solutions USA, Inc. | JAK | Class II | 2022-07-13 |
| K221434 | 17HQ701G-B | Lg Electronics.Inc | MQB | Class II | 2022-07-13 |
| K203279 | Veuron-Brain-mN1 | Heuron Co., Ltd. | LNH | Class II | 2022-07-12 |
| K220814 | NAEOTOM Alpha, Scan&GO Software | Siemens Medical Solutions USA, Inc. | JAK | Class II | 2022-07-12 |
| K213405 | MINE ALNU (Model: Mine 2.1) | Hdt Co., Ltd. | IZL | Class II | 2022-07-10 |
| K212783 | ProstatID | Scanmed, LLC | QDQ | Class II | 2022-07-08 |
| K213009 | Transcranial Doppler Ultrasound System | Shenzhen Delica Medical Equipment Co., Ltd. | IYN | Class II | 2022-07-08 |
| K221426 | Functional MR V1.0 | Olea Medical S.A.S. | LLZ | Class II | 2022-07-06 |
| K221025 | i_ Field 1.5T Superconducting Magnetic Resonance Imaging System | Mri Division,Beijing Wandong Medical Technology Co., Ltd. | LNH | Class II | 2022-07-01 |
| K213488 | Bladder Scanner, Model Name:M5 | Suzhou Peaksonic Medical Technology Co., Ltd. | IYO | Class II | 2022-07-01 |
| K220409 | ARTIS pheno (VE21) System | Siemens Medical Solutions USA, Inc. | OWB | Class II | 2022-06-29 |
| K221714 | Flat Panel Detector | Iray Technology Taicang , Ltd. | MQB | Class II | 2022-06-29 |
| K220975 | V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | 2022-06-29 |
| K220432 | ARTIS icono (VE21) System | Siemens Medical Solutions USA, Inc. | OWB | Class II | 2022-06-29 |
| K220848 | Venue Fit | GE Medical Systems | IYN | Class II | 2022-06-27 |
| K220851 | Venue | GE Medical Systems | IYN | Class II | 2022-06-27 |
| K220300 | OTOPLAN | Cascination AG | QQE | Class II | 2022-06-24 |
| K213439 | FlexBoardTM, EagleBoardTM, BreastBoard SXTM | Macromedics BV | IYE | Class II | 2022-06-24 |
| K220575 | MAGNETOM Free.Max, MAGNETOM Free.Star | Siemens Medical Solutions USA, Inc. | LNH | Class II | 2022-06-24 |
| K220993 | Ultrasound System SONIMAGE MX1 | Konica Minolta, Inc. | IYN | Class II | 2022-06-23 |
| K221511 | Axial3D Cloud Segmentation Service | Axial Medical Printing Limited | LLZ | Class II | 2022-06-23 |
| K220497 | CoLumbo | Smart Soft Healthcare AD | QIH | Class II | 2022-06-23 |
| K213665 | Syngo Carbon Space VA20A | Siemens Healthcare GmbH | LLZ | Class II | 2022-06-21 |
| K220800 | Venue Go | GE Medical Systems Ultrasound and Primary Care Diagnostics | IYN | Class II | 2022-06-21 |
| K221117 | RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | 2022-06-17 |
| K220813 | ART-PLAN | Therapanacea | QKB | Class II | 2022-06-17 |
| K221463 | ElucidVivo A.3 | Elucid Bioimaging, Inc. | LLZ | Class II | 2022-06-17 |
| K221408 | ARIA Radiation Therapy Management (v16.1 MR3) | Varian Medical Systems, Inc. | IYE | Class II | 2022-06-17 |
| K221345 | Wireless Digital Flat Panel Detector | Iray Technology Taicang , Ltd. | MQB | Class II | 2022-06-16 |
| K213504 | Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001A | Canon Medical Systems Corporation | JAK | Class II | 2022-06-16 |
| K213684 | SurgiCase Viewer | Materialise NV | LLZ | Class II | 2022-06-15 |
| K221448 | ARIA Radiation Therapy Management (v15.8), Eclipse Treatment Planning System (v15.8) | Varian Medical Systems, Inc. | IYE | Class II | 2022-06-15 |
| K221620 | Digital Radiography CXDI-Elite, Digital Radiography E1 | Canon, Inc. | MQB | Class II | 2022-06-14 |
| K221500 | ACUSON Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | IYN | Class II | 2022-06-14 |
| K221081 | iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray System | First Source, Inc. | IZL | Class II | 2022-06-13 |
| K221065 | MediLab | Sigma Scientific Services, LLC | LLZ | Class II | 2022-06-10 |
| K221393 | Swoop Portable MR Imaging System | Hyperfine, Inc. | LNH | Class II | 2022-06-10 |
| K213862 | HD60 Series Ultrasound Diagnostic System | Qingdao Hisense Medical Equipment Co., Ltd. | IYN | Class II | 2022-06-08 |
| K213717 | AIR Recon DL | Ge Medical Systems,Llc (Ge Healthcare) | LNH | Class II | 2022-06-08 |
| K221335 | D²RS and D²RS 9090 | Stephanix | OWB | Class II | 2022-06-07 |
| K213087 | Natural Rubber Latex Ultrasound Transducer Probe Covers | Global Protection Corp. | ITX | Class II | 2022-06-07 |
| K220358 | Voluson Expert 22, Voluson Expert 20, Voluson Expert 18 | GE Medical Systems Ultrasound and Primary Care Diagnostics | IYN | Class II | 2022-06-06 |
| K221314 | BriefCase | Aidoc Medical , Ltd. | QAS | Class II | 2022-06-03 |
| K221061 | 21HQ613D | Lg Electronics.Inc | PGY | Class II | 2022-06-03 |
| K213977 | TrueBeam, TrueBeam STx, Edge, VitalBeam | Varian Medical Systems, Inc. | IYE | Class II | 2022-06-03 |
| K220205 | 3D Anatomic Models | Ricoh USA, Inc. | LLZ | Class II | 2022-06-03 |
| K220164 | Rayvolve | Azmed Sas | QBS | Class II | 2022-06-02 |
| K213838 | AneuGuide | ArteryFlow Technology Co., Ltd. | PZO | Class II | 2022-06-01 |
| K221248 | Rapid LVO | Ischemaview, Inc. | QAS | Class II | 2022-05-31 |
| K221270 | EchoNavigator R4.0 | Philips Medical Systems Nederland B.V. | LLZ | Class II | 2022-05-31 |
| K213731 | EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows | Ever Fortune.Ai, Co., Ltd. | KPS | Class II | 2022-05-31 |
| K212873 | Aspire Cristalle | Fujifilm Corporation | MUE | Class II | 2022-05-27 |
| K220641 | Barrigel Injectable Gel | Palette Life Sciences | OVB | Class II | 2022-05-26 |
| K220416 | SwiftMR | Airs Medical, Inc. | LLZ | Class II | 2022-05-25 |
| K213829 | SCENARIA View | Fujifilm Healthcare Corporation | JAK | Class II | 2022-05-23 |
| K221000 | ON3D | 3D Ons, Inc. | LLZ | Class II | 2022-05-23 |
| K220832 | syngo Dynamics (Version VA40E) | Siemens Medical Solutions USA, Inc. | LLZ | Class II | 2022-05-20 |
| K212565 | CoverScan v1 | Perspectum, Ltd. | LLZ | Class II | 2022-05-19 |
| K220392 | PAPAYA 3D & PAPAYA 3D Plus | Genoray Co., Ltd. | OAS | Class II | 2022-05-19 |
| K221240 | BriefCase | Aidoc Medical , Ltd. | QAS | Class II | 2022-05-17 |
| K220919 | MULTIX Impact E | Siemens Medical Solutions USA, Inc. | KPR | Class II | 2022-05-17 |
| K213787 | Monaco RTP System | Elekta Solutions AB | MUJ | Class II | 2022-05-17 |
| K220499 | Rapid PE Triage and Notification (PETN) | Ischemaview, Inc. | QAS | Class II | 2022-05-17 |
| K221219 | syngo.CT CaScoring | Siemens Medical Solutions USA, Inc. | JAK | Class II | 2022-05-17 |
| K211665 | SONON Ultrasound Imaging System, Model: SONON300C | Healcerion Co., Ltd. | IYN | Class II | 2022-05-16 |
| K213583 | Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems | Philips Medical Systems Nederland B.V. | LNH | Class II | 2022-05-16 |
| K212376 | Caas Qardia | Pie Medical Imaging BV | LLZ | Class II | 2022-05-16 |
| K221106 | Quantib Prostate | Quantib B.V. | LLZ | Class II | 2022-05-13 |
| K212875 | Spectral CT on Rails | Philips Medical Systems Nederland B.V. | JAK | Class II | 2022-05-13 |
| K221144 | PEDRA-1417MC, PEDRA-1417MG, PEDRA-1417FC, PEDRA-1417FG | Radisen Co., Ltd. | MQB | Class II | 2022-05-13 |
| K220589 | MAGNETOM Skyra Fit | Siemens Medical Solutions USA, Inc. | LNH | Class II | 2022-05-13 |
| K213137 | INTDose | Carina Medical, LLC | IYE | Class II | 2022-05-13 |
| K221116 | XACT ACE Robotic System | Xact Robotics, Ltd. | JAK | Class II | 2022-05-13 |
| K220105 | Saige-Dx | DeepHealth, Inc. | QDQ | Class II | 2022-05-12 |
| K212909 | VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips | Macromedics BV | IYE | Class II | 2022-05-11 |
| K220446 | Versana Balance | GE Medical Systems Ultrasound and Primary Care Diagnostics | IYN | Class II | 2022-05-11 |
| K212519 | Overjet Caries Assist | Overjet, Inc. | MYN | Class II | 2022-05-10 |
| K220727 | inHEART MODELS | Inheart, Sas | LLZ | Class II | 2022-05-10 |
| K221136 | RadiForce MX243W | Eizo Corporation | PGY | Class II | 2022-05-10 |
| K213975 | KEOPS Balance Analyzer 3D | S.M.A.I.O | LLZ | Class II | 2022-05-06 |
| K220664 | NewTom 7G | Cefla S.C. | JAK | Class II | 2022-05-06 |
| K220269 | HM70 EVO Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | 2022-05-06 |
| K211966 | Segment 3DPrint | Medviso AB | LLZ | Class II | 2022-05-06 |
| K211529 | NAVIRFA Scope | Navifus Corporation | IYO | Class II | 2022-05-05 |
| K220559 | 17HQ901G-B | Lg Electronics.Inc | MQB | Class II | 2022-05-05 |
| K220700 | Heart5R-110 Portable X-Ray Machine, Heart3R-110 Portable X-ray Machine | Yian Medical Technology (Haining) Co., Ltd. | IZL | Class II | 2022-05-04 |
| K213526 | Aurora-RT | Magnettx Oncology Solutions , Ltd. | IYE | Class II | 2022-05-04 |
| K220311 | Cardiovascular Angiography System | Allengers Medical Systems Limited | OWB | Class II | 2022-05-03 |
| K213302 | exoplan | Exocad GmbH | LLZ | Class II | 2022-05-03 |
14,721 clearances in the Radiology panel. Data: openFDA.