Review Panel
Radiology FDA 510(k) Clearances & Devices
- Cleared Devices
- 14,721
- Product Codes (page)
- 27
- Latest Decision
- 2021-05-06
Clearances · page 25 of 148
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K210066 | ImagePilot | Konica Minolta, Inc. | LLZ | Class II | 2021-05-06 |
| K211034 | Corvus Radiation Therapy Planning System | Best Nomos | MUJ | Class II | 2021-05-06 |
| K210682 | SOTA Cloud Imaging | Sota Precision Optics, Inc. Dba Sota Imaging | LLZ | Class II | 2021-05-04 |
| K202521 | PtoleMedic System | Lento Medical Innovation, Inc. | LLZ | Class II | 2021-05-04 |
| K210919 | AcuityDRe | Radmedix, LLC | MQB | Class II | 2021-04-30 |
| K210001 | HYPER AiR | Shanghai United Imaging Healthcare Co., Ltd. | KPS | Class II | 2021-04-30 |
| K203699 | syngo. CT Extended Functionalities | Siemens Medical Solutions USA, Inc. | JAK | Class II | 2021-04-30 |
| K210985 | 1717FCC | Rayence Co., Ltd. | MQB | Class II | 2021-04-28 |
| K203451 | TCL3 Motion Tracking System | Tracinnovations Aps | LNH | Class II | 2021-04-28 |
| K203535 | Trinias | Shimadzu Corporation Medical Systems | OWB | Class II | 2021-04-28 |
| K210982 | AMX Navigate | Ge Medical Systems, LLC | IZL | Class II | 2021-04-28 |
| K203314 | Cartesion Prime (PCD-1000A/3) V10.8 | Canon Medical Systems Corporation | KPS | Class II | 2021-04-23 |
| K203502 | MEDO-Thyroid | Medo DX Pte. , Ltd. | QIH | Class II | 2021-04-23 |
| K210345 | 2MP Monochrome LCD Monitor MS-S200 | Jvckenwood Corporation | PGY | Class II | 2021-04-23 |
| K210988 | Yushan X-Ray Flat Panel Detector with DROC | Innocare Optoelectronics Corp. | MQB | Class II | 2021-04-21 |
| K210556 | Preview Shoulder | Genesis Software Innovations | QIH | Class II | 2021-04-21 |
| K203610 | Automatic Anatomy Recognition (AAR) | Quantitative Radiology Solutions, LLC | QKB | Class II | 2021-04-20 |
| K210835 | Identify | Varian Medical Systems, Inc. | IYE | Class II | 2021-04-20 |
| K203469 | AI Segmentation | Varian Medical Systems, Inc. | MUJ | Class II | 2021-04-19 |
| K200271 | rainbow CT | Dentium Co., Ltd (Ict Branch) | OAS | Class II | 2021-04-16 |
| K200270 | rainbow MCT | Dentium Co., Ltd (Ict Branch) | OAS | Class II | 2021-04-16 |
| K203517 | Saige-Q | DeepHealth, Inc. | QFM | Class II | 2021-04-16 |
| K202992 | BriefCase, RIB Fractures Triage (RibFx) | Aidoc Medical , Ltd. | QFM | Class II | 2021-04-14 |
| K210493 | CX30N (CX30PQX) | Wide Corporation | PGY | Class II | 2021-04-14 |
| K202679 | Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3 | Mcgovern Medical School | KPS | Class II | 2021-04-12 |
| K210900 | Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2 | Canon Medical Systems Corporation | OWB | Class II | 2021-04-12 |
| K202084 | DeepLook PRECISE | Deeplook, Inc. | LLZ | Class II | 2021-04-09 |
| K210418 | HYPER Focus | Shanghai United Imaging Healthcare Co., Ltd. | KPS | Class II | 2021-04-09 |
| K203681 | RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT QA, Dose Review | Brainlab AG | MUJ | Class II | 2021-04-09 |
| K210068 | HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | 2021-04-09 |
| K210491 | CW120N | Wide Corporation | PGY | Class II | 2021-04-08 |
| K202785 | Resona R9,Resona R9 Exp,Resona R9 Pro,Resona R9S, Nuewa R9,Nuewa R9 Exp,Nuewa R9 Pro,Nuewa R9S,Resona 7,Resona 7CV,Resona 7EXP,Resona 7S, Resona 7OB,Resona 7PRO,Imagyn 7,Resona Y Diagnostic Ultrasound System | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. | IYN | Class II | 2021-04-08 |
| K203623 | StentBoost Mobile | Philips India Limited | OWB | Class II | 2021-04-05 |
| K210850 | ADAS 3D | Adas3D Medical S.L. | LLZ | Class II | 2021-04-05 |
| K210692 | DigitalDiagnost | Philips Medical Systems Dmc GmbH | KPR | Class II | 2021-04-02 |
| K202441 | Eclipse II with Smart Noise Cancellation | Carestream Health, Inc. | MQB | Class II | 2021-04-02 |
| K202928 | DV. Target | Deepvoxel, Inc. | QKB | Class II | 2021-04-02 |
| K210743 | ACUSON Redwood Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | IYN | Class II | 2021-04-01 |
| K210340 | Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | LNH | Class II | 2021-04-01 |
| K203195 | Simpleware ScanIP Medical | Synopsys (Northern Europe) , Ltd. | LLZ | Class II | 2021-04-01 |
| K203782 | Nanox Cart X-ray System | Nano-X Imaging , Ltd. | IZL | Class II | 2021-04-01 |
| K203258 | syngo.CT Lung CAD | Siemens Healthcare GmbH | OEB | Class II | 2021-03-31 |
| K203443 | MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea | Siemens Medical Solutions USA, Inc. | LNH | Class II | 2021-03-31 |
| K210071 | SIS System (Version 5.1.0) | Surgical Information Sciences, Inc. | LLZ | Class II | 2021-03-31 |
| K210173 | StarGuide | GE Healthcare | KPS | Class II | 2021-03-29 |
| K202547 | Surgivisio system | Surgivisio | OWB | Class II | 2021-03-26 |
| K203273 | FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630) | Echosens | IYO | Class II | 2021-03-25 |
| K203225 | Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System | Canon Medical Systems Corporation | JAK | Class II | 2021-03-24 |
| K203703 | I-Q View | First Source, Inc. | MQB | Class II | 2021-03-24 |
| K210209 | Viz ICH | Viz. Ai, Inc. | QAS | Class II | 2021-03-23 |
| K203391 | TE7/TE5/TE7 Max/TE5 Max/TE9 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | Class II | 2021-03-23 |
| K210479 | IMPACT and X-Ranger | Minxray, Inc. | IZL | Class II | 2021-03-19 |
| K203235 | VBrain | Vysioneer, Inc. | QKB | Class II | 2021-03-19 |
| K203428 | Ziehm Vision RFD | Ziehm Imaging GmbH | JAA | Class II | 2021-03-17 |
| K210450 | BBX-PET Scanner | Prescient Imaging, LLC | KPS | Class II | 2021-03-17 |
| K203822 | ProFound AI Software V3.0 | Icad, Inc. | QDQ | Class II | 2021-03-12 |
| K203188 | ADD | H&abyz Co., Ltd. | MQB | Class II | 2021-03-12 |
| K203250 | TaiChiC | Our United Corporation | IWB | Class II | 2021-03-12 |
| K202284 | Oncospace | Oncospace, Inc. | MUJ | Class II | 2021-03-12 |
| K210164 | Vantage Elan 1.5T, MRT-2020, V6.0 | Canon Medical Systems Corporation | LNH | Class II | 2021-03-10 |
| K203256 | Imbio RV/LV Software | Imbio, LLC | QIH | Class II | 2021-03-09 |
| K203518 | Quicktome | Omniscient Neurotechnology Pty Ltd (O8t) | LLZ | Class II | 2021-03-09 |
| K203146 | Akesis Galaxy RTi | Akesis, Inc. | IWB | Class II | 2021-03-05 |
| K202300 | Optellum Virtual Nodule Clinic, Optellum software, Optellum platform | Optellum, Ltd. | POK | Class II | 2021-03-05 |
| K203346 | OEC 3D | Ge Oec Medical Systems, Inc. | OXO | Class II | 2021-03-05 |
| K202658 | Vivid E80/ Vivid E90/ Vivid E95 | GE Medical Systems Ultrasound and Primary Care Diagnostics | IYN | Class II | 2021-03-05 |
| K210309 | Cios Select (VA21) Flat Panel | Siemens Medical Solutions USA, Inc. | OWB | Class II | 2021-03-05 |
| K210307 | Cios Select (VA21) Image Intensifier | Siemens Medical Solutions USA, Inc. | OWB | Class II | 2021-03-04 |
| K203387 | AlignRT Plus | Vision Rt, Ltd. | IYE | Class II | 2021-03-04 |
| K203323 | Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | LNH | Class II | 2021-03-04 |
| K202518 | Promaxo MRI System | Promaxo, Inc. | LNH | Class II | 2021-03-03 |
| K210316 | Mars 1417X Wireless Digital Flat Panel Detector | Iray Technology Taicang , Ltd. | MQB | Class II | 2021-03-03 |
| K210262 | Biograph Vision Quadra PET/CT System | Siemens Medical Solutions USA, Inc. | KPS | Class II | 2021-03-03 |
| K203617 | MaxFOV 2 | Ge Medical Systems, LLC | JAK | Class II | 2021-03-02 |
| K210314 | Mars1717X Wireless Digital Flat Panel Detector | Iray Technology Taicang , Ltd. | MQB | Class II | 2021-03-02 |
| K203653 | MRI PPG Patient Cable | Ivy Biomedical Systems, Inc. | LNH | Class II | 2021-03-02 |
| K201965 | SonoEye P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital Color Doppler Palm Ultrasound System | CHISON Medical Technologies Co., Ltd. | IYN | Class II | 2021-03-02 |
| K201967 | SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound System | CHISON Medical Technologies Co., Ltd. | IYN | Class II | 2021-02-26 |
| K203182 | SubtleMR | Subtle Medical, Inc. | LLZ | Class II | 2021-02-26 |
| K201316 | Bladder Scanner (Model: M3, M3-HD, M4, M4-HD) | Suzhou Peaksonic Medical Technology Co., Ltd. | IYO | Class II | 2021-02-26 |
| K203651 | Cuptimize | Cuptimize, Inc. | LLZ | Class II | 2021-02-26 |
| K201968 | SonoEye P3/ SonoEye V3/ Sono Eye G3 Digital Color Doppler Palm Ultrasound System | CHISON Medical Technologies Co., Ltd. | IYN | Class II | 2021-02-26 |
| K203020 | Spectral CT | Philips Medical Systems Nederland B.V. | JAK | Class II | 2021-02-26 |
| K201971 | SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound System | CHISON Medical Technologies Co., Ltd. | IYN | Class II | 2021-02-25 |
| K201969 | SonoEye P6/ SonoEye V6/ SonoEye G6 Digital Color Doppler Palm Ultrasound System | CHISON Medical Technologies Co., Ltd. | IYN | Class II | 2021-02-25 |
| K202514 | EchoS Family | Echolight S.P.A | MUA | Class II | 2021-02-25 |
| K203578 | OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System | Perimeter Medical Imaging Ai, Inc. | NQQ | Class II | 2021-02-25 |
| K202990 | NinesMeasure | Nines, Inc. | LLZ | Class II | 2021-02-25 |
| K202789 | Monaco Rtp System | Elekta Solutions AB | MUJ | Class II | 2021-02-23 |
| K201501 | Veolity | MeVis Medical Solutions AG | OEB | Class II | 2021-02-23 |
| K203406 | Lumify Diagnostic Ultrasound System | Philips Ultrasound, Inc. | IYN | Class II | 2021-02-23 |
| K203784 | PreXion3D Explorer PRO | Prexion Corporation | OAS | Class II | 2021-02-23 |
| K201743 | ClarifEye R1.0, ClarifEye Needle | Philips Medical Systems Nederlands B.V. | OWB | Class II | 2021-02-23 |
| K201425 | Disposable Intraoperative Probe (DIOP8) | Huntleigh Healthcare Limited | ITX | Class II | 2021-02-19 |
| K200589 | MyPAO Planning Report | Medacta International S.A. | LLZ | Class II | 2021-02-19 |
| K202212 | TruPlan | Circle Cardiovascular Imaging, Inc. | LLZ | Class II | 2021-02-19 |
| K202995 | X-ray Flat Panel Detectors/CareView 3600RF | Careray Digital Medical System Co., Ltd. | MQB | Class II | 2021-02-19 |
| K210329 | Green X 18(Model : PHT-75CHS) | VATECH Co., Ltd. | OAS | Class II | 2021-02-18 |
| K210136 | PhantomMSK Hip | OrthoGrid Systems, Inc. | LLZ | Class II | 2021-02-18 |
| K201378 | 3D Accuitomo 150N | J. Morita USA, Inc. | OAS | Class II | 2021-02-18 |
14,721 clearances in the Radiology panel. Data: openFDA.