Review Panel
Radiology FDA 510(k) Clearances & Devices
- Cleared Devices
- 14,721
- Product Codes (page)
- 30
- Latest Decision
- 2023-01-23
Clearances · page 18 of 148
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K222406 | Clarius AI | Clarius Mobile Health Corp. | QIH | Class II | 2023-01-23 |
| K221725 | Advanced MyHip Planner | Medacta International S.A. | LLZ | Class II | 2023-01-20 |
| K223842 | DRX - Compass | Carestream Health, Inc. | KPR | Class II | 2023-01-20 |
| K221627 | PerfusionGo Plus | Yukun (Beijing) Technology Co., Ltd. | LLZ | Class II | 2023-01-19 |
| K223804 | PercuNav Image Fusion and Interventional Navigation System | Philips Ultrasound, LLC | JAK | Class II | 2023-01-18 |
| K222593 | TruPlan Computed Tomography (CT) Imaging Software | Circle Cardiovascular Imaging, Inc. | LLZ | Class II | 2023-01-18 |
| K223794 | hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS | Cefla S.C. | OAS | Class II | 2023-01-17 |
| K223800 | MIM Additional Tracers | Mim Software, Inc. | LLZ | Class II | 2023-01-17 |
| K220649 | Elucis | Realize Medical, Inc. | LLZ | Class II | 2023-01-17 |
| K222941 | Halcyon, Ethos Radiotherapy System | Varian Medical Systems, Inc. | IYE | Class II | 2023-01-17 |
| K223502 | MR Diffusion Perfusion Mismatch V1.0 | Olea Medical | LLZ | Class II | 2023-01-13 |
| K223429 | Contour Knee | Quality Electrodynamics, LLC | MOS | Class II | 2023-01-13 |
| K222150 | PreXion3D Expedition | Prexion Corporation | OAS | Class II | 2023-01-12 |
| K223363 | MAMMOVISTA B.smart (VB70) | Siemens Medical Solutions USA, Inc. | LLZ | Class II | 2023-01-12 |
| K222458 | AIBOLIT 3D+ | Aibolit Technologies, LLC | LLZ | Class II | 2023-01-12 |
| K223465 | RadianceTx Radionuclide Brachytherapy Source | Radiance Therapeutics, Inc. | KXK | Class II | 2023-01-11 |
| K221278 | Transducer Probe Cover | Hony Medical Co., Ltd. | ITX | Class II | 2023-01-11 |
| K223336 | Vitrea Software Package, VSTP-002A | Canon Medical Systems Corporation | LLZ | Class II | 2023-01-09 |
| K222787 | Sunkingdom Ophthalmic Ultrasound Examination Instrument SK-3000A, SK-3000B, SK-3000C, SK-2000AP, SK-2000A, SK-2000P | Chongqing Sunkingdom Medical Instrument Co., Ltd. | IYO | Class II | 2023-01-09 |
| K223789 | 21HQ513D | Lg Electronics.Inc | PGY | Class II | 2023-01-09 |
| K222577 | TECHFIT Diagnostic Models | Techfit Digital Surgery, Inc. | LLZ | Class II | 2023-01-06 |
| K213263 | OnyxCeph | Image Instruments GmbH | LLZ | Class II | 2023-01-04 |
| K223378 | 3.0T 16ch AIR AA | Ge Healthcare Coils (Usa Instruments, Inc.) | MOS | Class II | 2023-01-03 |
| K222767 | PeekMed web (v1) | Peek Health, S.A. | LLZ | Class II | 2022-12-30 |
| K223687 | X-ray Flat Panel Detectors (EverestView 4343X) | Careray Digital Medical Technology Co., Ltd. | MQB | Class II | 2022-12-30 |
| K221796 | Cyware 4H and Cysart 4H | Abys Medical | LLZ | Class II | 2022-12-30 |
| K222195 | aprevo® Digital Workflow | Carlsmed, Inc. | LLZ | Class II | 2022-12-30 |
| K221344 | nView s1 with nav option | Nview Medical | OWB | Class II | 2022-12-28 |
| K212239 | XENOVIEW 3.0T Chest Coil | Polarean, Inc. | MOS | Class II | 2022-12-23 |
| DEN220017 | BioXmark | Nanovi A/S | QUV | Class II | 2022-12-23 |
| K223442 | MR 5300 and MR 7700 R11 MR Systems | Philips Medical Systems Nederlands B.V. | LNH | Class II | 2022-12-23 |
| K214036 | AVIEW | Coreline Soft Co., Ltd. | QIH | Class II | 2022-12-23 |
| K223071 | Xenoview VDP | Polarean, Inc. | LLZ | Class II | 2022-12-23 |
| K223311 | Philips CT 3500 | Philips Healthcare (Suzhou) Co., Ltd. | JAK | Class II | 2022-12-22 |
| K223547 | Biograph Vision Quadra PET/CT System | Siemens Medical Solutions USA, Inc. | KPS | Class II | 2022-12-22 |
| K222864 | 8MP Color LCD Monitor CL-R813 | Jvckenwood Corporation | PGY | Class II | 2022-12-21 |
| K221911 | VINNO 6PRO, VINNO 6EXP, VINNO 5PRO, VINNO 5EXP, VINNO 3, VINNO 3PRO, VINNO 3EXP | Vinno Technology (Suzhou) Co.,Ltd | IYN | Class II | 2022-12-21 |
| K222896 | AirRay | Poskom Co., Ltd. | IZL | Class II | 2022-12-20 |
| K222275 | Saige-Density | DeepHealth, Inc. | QIH | Class II | 2022-12-16 |
| K223268 | BrainInsight | Hyperfine, Inc. | QIH | Class II | 2022-12-16 |
| K220928 | Overjet Calculus Assist | Overjet, Inc. | MYN | Class II | 2022-12-16 |
| K220883 | Small Field Applicator | Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha | LHN | Class II | 2022-12-15 |
| K220822 | 3D-SHAPER | 3D-Shaper Medical S.L | KGI | Class II | 2022-12-09 |
| K223239 | 8ch Wrist Coil | Shenzhen RF Tech Co., Ltd. | MOS | Class II | 2022-12-08 |
| K223487 | InkSpace Imaging Body Array | Inkspace Imaging, Inc. | MOS | Class II | 2022-12-08 |
| K222441 | Ultrasound System 2300 | Bk Medical Aps | IYN | Class II | 2022-12-07 |
| K223410 | Cios Select (VA21) Flat Panel | Siemens Medical Solutions USA, Inc. | OWB | Class II | 2022-12-07 |
| K222219 | R2 Studio Q/RCT820 | Megagen Implant Co., Ltd. | OAS | Class II | 2022-12-06 |
| K222320 | MedDream | Softneta Uab | LLZ | Class II | 2022-12-06 |
| K223409 | Cios Select (VA21) Image Intensifier | Siemens Medical Solutions USA, Inc. | OWB | Class II | 2022-12-06 |
| K223247 | Swoop Portable MR Imaging System | Hyperfine, Inc. | LNH | Class II | 2022-12-06 |
| K222692 | BriefCase | Aidoc Medical , Ltd. | QFM | Class II | 2022-12-05 |
| K221612 | ClearRead CT | Riverain Technologies, Inc. | OEB | Class II | 2022-12-05 |
| K213465 | CardioGraphe | Arineta , Ltd. | JAK | Class II | 2022-12-02 |
| K221791 | ProBeam 360° Proton Therapy System | Varian Medical Systems, Inc. | LHN | Class II | 2022-12-01 |
| K213768 | Bolt Navigation System | Circinus Medical Technology, LLC | OWB | Class II | 2022-12-01 |
| K220630 | TorchTM Software | Voximetry, Incorporated | LLZ | Class II | 2022-11-28 |
| K223009 | Wireless/Wired X-Ray Flat Panel Detectors | Allengers Medical Systems Limited | MQB | Class II | 2022-11-27 |
| K213215 | VSI HoloMedicine | Apoqlar GmbH | LLZ | Class II | 2022-11-25 |
| K221716 | CINA | Avicenna.Ai | QAS | Class II | 2022-11-22 |
| K221624 | Avenda Health AI Prostate Cancer Planning Software | Avenda Health, Inc. | POK | Class II | 2022-11-22 |
| K221499 | Minimally Invasive Prostate Surgery Navigation System | Augment Intelligent Medical System (China) Co., Ltd. | LLZ | Class II | 2022-11-22 |
| K222054 | Denti.AI Auto-Chart | Denti.Ai Technology, Inc. | LLZ | Class II | 2022-11-22 |
| K223152 | Vision 2, EVARVision, TrackVision 2, HeartVision 2 | GE Medical Systems SCS | LLZ | Class II | 2022-11-22 |
| K222052 | VitroPRO | CIVCO Medical Instruments Co., Inc. | ITX | Class II | 2022-11-22 |
| K222895 | DynamicIQ | GE Medical Systems SCS | KPS | Class II | 2022-11-22 |
| K220663 | AccuCTP | ArteryFlow Technology Co., Ltd. | LLZ | Class II | 2022-11-22 |
| K222951 | SM-V | Sedecal., Sa. | IZL | Class II | 2022-11-21 |
| K223032 | SIS System (Version 5.6.0) | Surgical Information Sciences, Inc. | QIH | Class II | 2022-11-21 |
| K223124 | EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG | DRTECH Corporation | MQB | Class II | 2022-11-18 |
| K221330 | BriefCase | Aidoc Medical , Ltd. | QAS | Class II | 2022-11-18 |
| K221281 | Multitom Rax | Siemens Medical Solutions | OWB | Class II | 2022-11-17 |
| K223267 | SKR 3000 | Konica Minolta, Inc. | MQB | Class II | 2022-11-17 |
| K222208 | Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30D | Qingdao Hisense Medical Equipment Co., Ltd. | PGY | Class II | 2022-11-17 |
| K222476 | OmegaAI Image Viewer | Ramsoft, Inc. | LLZ | Class II | 2022-11-17 |
| K221762 | BoneMRI v1.4 | Mrlguidance B.V. | QIH | Class II | 2022-11-16 |
| K222540 | uPMR 790 | Shanghai United Imaging Healthcare Co., Ltd. | OUO | Class II | 2022-11-14 |
| K222428 | Syngo Dynamics (Version VA40F) | Siemens Medical Solutions USA, Inc. | QIH | Class II | 2022-11-14 |
| K220983 | ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging System | Imsonic Medical China, Inc. | IYN | Class II | 2022-11-11 |
| K221677 | Synapse 3D Base Tools v6.6 | Fujifilm Corporation | LLZ | Class II | 2022-11-10 |
| K220408 | AVIEW RT ACS | Coreline Soft Co., Ltd. | QKB | Class II | 2022-11-10 |
| K222198 | Exo Iris (El2001) | Exo Imaging, Inc. | IYN | Class II | 2022-11-09 |
| K221539 | GammaTile | Gt Medical Technologies | KXK | Class II | 2022-11-09 |
| K222754 | ViewMate Multi Ultrasound System | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. | IYN | Class II | 2022-11-09 |
| K222132 | Hisense LCD monitor HMD2G21S, HMD3G21S | Qingdao Hisense Medical Equipment Co., Ltd. | PGY | Class II | 2022-11-08 |
| K221552 | EFAI ChestSuite XR Pneumothorax Assessment System | Ever Fortune.Ai, Co., Ltd. | QFM | Class II | 2022-11-08 |
| K222639 | VHA Radiotherapy Bolus | Vha Dean | IXI | Class II | 2022-11-04 |
| K221478 | Dolphin Blue Imaging | Patterson Dental Supply, Inc. | LLZ | Class II | 2022-11-01 |
| K220539 | Klarity SRS Baseplate, Klarity Promise Baseplate | Klarity Medical & Equipment (GZ) Co., Ltd. | IYE | Class II | 2022-11-01 |
| K222258 | Combined High Frequency X-ray Source | Suzhou Powersite Electric Co., Ltd. | IZL | Class II | 2022-11-01 |
| K222717 | CL24N | Wide Corporation | PGY | Class II | 2022-10-31 |
| K222722 | CW60N | Wide Corporation | PGY | Class II | 2022-10-31 |
| K220929 | Excelsior | Merit Cro, Inc. | NFJ | Class II | 2022-10-31 |
| K222191 | Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC MACH40 | Supersonic Imagine | IYN | Class II | 2022-10-28 |
| K223079 | Stage | Spintech, Inc. | LNH | Class II | 2022-10-28 |
| K220332 | uMR Omega with uWS-MR-MRS | Shanghai United Imaging Healthcare Co., Ltd. | LNH | Class II | 2022-10-27 |
| K223060 | DigiX FDX | Allengers Medical Systems Limited | KPR | Class II | 2022-10-26 |
| K222047 | Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant) | Elekta Solutions AB | IWB | Class II | 2022-10-26 |
| K222968 | Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | LNH | Class II | 2022-10-25 |
| K222070 | EndoNaut | Therenva Sas | OWB | Class II | 2022-10-25 |
14,721 clearances in the Radiology panel. Data: openFDA.