Review Panel
Radiology FDA 510(k) Clearances & Devices
- Cleared Devices
- 14,721
- Product Codes (page)
- 25
- Latest Decision
- 2023-12-14
Clearances · page 14 of 148
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K231570 | StrokeViewer Perfusion | Nico-Lab B.V. | LLZ | Class II | 2023-12-14 |
| K230950 | ARTIS icono (VE30A) | Siemens Medical Solutions USA, Inc. | OWB | Class II | 2023-12-14 |
| K231181 | bright CT | Dentium Co., Ltd (Ict Branch) | OAS | Class II | 2023-12-14 |
| K232231 | QP-Brain® | Quibim S.L. | QIH | Class II | 2023-12-13 |
| K232680 | fMRI Hardware System | Nordicneurolab AS | LNH | Class II | 2023-12-13 |
| K231666 | Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) | FUJIFILM Healthcare Americas Corporation | ITX | Class II | 2023-12-13 |
| K231669 | Ziehm Solo FD | Ziehm Imaging GmbH | OWB | Class II | 2023-12-12 |
| K233634 | TeleScan | Bb Imaging | LLZ | Class II | 2023-12-12 |
| K232985 | 24HR513C | Lg Electronics.Inc | PGY | Class II | 2023-12-11 |
| K232096 | Transpara Density 1.0.0 | Screenpoint Medical B.V. | QIH | Class II | 2023-12-11 |
| K233693 | Nio Color 8MP (MDNC-8132) | Barco N.V. | PGY | Class II | 2023-12-11 |
| K223757 | Bonelogic | Disior, Ltd. | QIH | Class II | 2023-12-08 |
| K231898 | DTX Studio Clinic (4.0) | Nobel Biocare AB | LLZ | Class II | 2023-12-08 |
| K232381 | LOGIQ Totus | GE Medical Systems Ultrasound and Primary Care Diagnostics | IYN | Class II | 2023-12-07 |
| K232661 | Myocardial Strain Software Application | Circle Cardiovascular Imaging | LLZ | Class II | 2023-12-07 |
| K232206 | SOMATOM Pro.Pulse | Siemens Medical Solutions USA, Inc. | JAK | Class II | 2023-12-06 |
| K233597 | Sonosite LX Ultrasound System | FUJIFILM Sonosite, Inc. | IYN | Class II | 2023-12-06 |
| K233334 | Aquilion Serve SP (TSX-307B/1) V1.3 | Canon Medical Systems Corporation | JAK | Class II | 2023-12-06 |
| K233568 | Ceevra Reveal 3+ | Ceevra, Inc. | QIH | Class II | 2023-12-05 |
| K232440 | Adravision Perio | Adra Corporation | QIH | Class II | 2023-12-05 |
| K232856 | Syngo Carbon Clinicals | Siemens Healthcare GmbH | QIH | Class II | 2023-12-01 |
| K233545 | EPIQ Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | IYN | Class II | 2023-11-30 |
| K232155 | syngo.CT Dual Energy | Siemens Medical Solutions USA, Inc. | JAK | Class II | 2023-11-30 |
| K230179 | 6440 MyLabX90 | Esaote, S.p.A. | IYN | Class II | 2023-11-29 |
| K233532 | MULTIX Impact E | Siemens Medical Solutions | KPR | Class II | 2023-11-29 |
| K231482 | uCT ATLAS Astound with uWS-CT-Dual Energy Analysis, uCT ATLAS with uWS-CT-Dual Energy Analysis | Shanghai United Imaging Healthcare Co., Ltd. | JAK | Class II | 2023-11-29 |
| K232000 | syngo.via MI Workflows; Scenium; syngo MBF | Siemens Medical Solutions USA, Inc. | QIH | Class II | 2023-11-28 |
| K231631 | BriefCase-Quantification | Aidoc Medical , Ltd. | JAK | Class II | 2023-11-28 |
| K232988 | Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound System | Canon Medical Systems Corporation | IYN | Class II | 2023-11-21 |
| K233049 | TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with QwikCheck Chemical Indicator | Cs Medical, LLC | PSW | Class II | 2023-11-21 |
| K232496 | Brainomix 360 Triage Stroke | Brainomix Limited | QAS | Class II | 2023-11-21 |
| K232555 | Harmony | Topcon Healthcare Solutions | NFJ | Class II | 2023-11-20 |
| K231498 | TraumaCad Neo | Brainlab , Ltd. | LLZ | Class II | 2023-11-20 |
| K231692 | Ziehm Vision RFD | Ziehm Imaging GmbH | OWB | Class II | 2023-11-20 |
| K231941 | ARIETTA x10 | FUJIFILM Healthcare Americas Corporation | IYN | Class II | 2023-11-20 |
| K232501 | AI Platform (AIP001) | Exo, Inc. | QIH | Class II | 2023-11-17 |
| K232392 | CT Lung Ventilation Analysis Software (CT:V) | 4Dmedical Limited | JAK | Class II | 2023-11-16 |
| K233200 | XPLUS 35 Series (XPLUS 35, XPLUS 35FD) | GEMSS HEALTHCARE CO., LTD. | OWB | Class II | 2023-11-16 |
| K232753 | EXPD 4343D; EXPD 3643D | DRTECH Corporation | MQB | Class II | 2023-11-16 |
| K231852 | BinkieRT | Papricalab | IYE | Class II | 2023-11-15 |
| K232841 | Axial3D Insight | Axial Medical Printing Limited | QIH | Class II | 2023-11-15 |
| K231783 | VitroPRO | CIVCO Medical Instruments Co., Inc. | ITX | Class II | 2023-11-14 |
| K232494 | MAGNETOM Avanto fit; MAGNETOM Skyra fit | Siemens Medical Solutions USA, Inc. | LNH | Class II | 2023-11-14 |
| K230856 | BrainSpec Core Software | Brainspec, Inc. | LLZ | Class II | 2023-11-14 |
| K232257 | Clarius Bladder AI | Clarius Mobile Health Corp. | QIH | Class II | 2023-11-13 |
| K232083 | BriefCase-Quantification | Aidoc Medical , Ltd. | QIH | Class II | 2023-11-13 |
| K231617 | MAGNETOM Free.Max; MAGNETOM Free.Star | Siemens Medical Solutions USA, Inc. | LNH | Class II | 2023-11-09 |
| K223754 | BraveCX | Bering, Ltd. | QFM | Class II | 2023-11-09 |
| K231765 | Contour ProtégéAI | Mim Software, Inc. | QKB | Class II | 2023-11-08 |
| K230534 | BriefCase-Quantification | Aidoc Medical , Ltd. | QIH | Class II | 2023-11-08 |
| K231966 | LOGIQ E10 | GE Medical Systems Ultrasound and Primary Care Diagnostics | IYN | Class II | 2023-11-07 |
| K231989 | LOGIQ E10s, LOGIQ Fortis | Ge Medical Systems Ultrasound and Primary Care Diagnostic, | IYN | Class II | 2023-11-07 |
| K231470 | Lunit INSIGHT DBT | Lunit, Inc. | QDQ | Class II | 2023-11-06 |
| K232113 | Halcyon, Ethos Radiotherapy System | Varian Medical Systems, Inc. | IYE | Class II | 2023-11-03 |
| K231955 | aprevo® Digital Segmentation | Carlsmed, Inc. | QIH | Class II | 2023-11-03 |
| K232186 | LOGIQ e | Ge Medical Systems Ultrasound and Primary Care Diagnostic, | IYN | Class II | 2023-11-03 |
| K230800 | XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50 | GEMSS HEALTHCARE CO., LTD. | KPR | Class II | 2023-11-02 |
| K231965 | Voluson Expert 22, Voluson Expert 20, Voluson Expert 18 | GE Medical Systems Ultrasound and Primary Care Diagnostics | IYN | Class II | 2023-10-30 |
| K232145 | ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | IYN | Class II | 2023-10-30 |
| K232751 | BriefCase-Triage | Aidoc Medical , Ltd. | QAS | Class II | 2023-10-30 |
| K232045 | MeVis Liver Suite | MeVis Medical Solutions AG | JAK | Class II | 2023-10-27 |
| K232346 | Digital Expert Access with Remote Scanning | GE Healthcare | LNH | Class II | 2023-10-27 |
| K231761 | PodSKAN HF Diagnostic X-ray System | Skanray Technologies Limited | KPR | Class II | 2023-10-27 |
| K230854 | SwiftMR | Airs Medical, Inc. | LLZ | Class II | 2023-10-27 |
| K232500 | Lumify Diagnostic Ultrasound System | Philips Ultrasound | IYN | Class II | 2023-10-26 |
| K231685 | TE Air Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | Class II | 2023-10-26 |
| K231995 | AcuityUDR | Radmedix, LLC | KPR | Class II | 2023-10-25 |
| K232436 | Rapid SDH | Ischemaview, Inc. | QAS | Class II | 2023-10-25 |
| K230511 | K3900 Ultrasound Imaging System | Maui Imaging | IYO | Class II | 2023-10-25 |
| K231509 | Aco Apache Ultrasound System | Aco Healthcare Co., Ltd. | IYN | Class II | 2023-10-24 |
| K232086 | spineEOS | Eos Imaging | LLZ | Class II | 2023-10-24 |
| K233348 | 16 Breast Coil | Philips Medical System Nederlands B.V. | MOS | Class II | 2023-10-24 |
| K231764 | Ultrasound System 1300 | Bk Medical Aps | IYN | Class II | 2023-10-23 |
| K232305 | AI-Rad Companion Brain MR | Siemens Medical Solutions U.S.A. | QIH | Class II | 2023-10-23 |
| K231560 | MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit | Siemens Medical Solutions USA, Inc. | LNH | Class II | 2023-10-23 |
| K230209 | Sonix Health | Ontact Health Co., Ltd. | QIH | Class II | 2023-10-20 |
| K223909 | R2GATE Lite TM | Megagen Implant Co., Ltd. | LLZ | Class II | 2023-10-20 |
| K232910 | CombiDiagnost R90 | Philips Medical Systems Dmc GmbH | JAA | Class II | 2023-10-19 |
| K231225 | EConsole1 | DRTECH Corporation | LLZ | Class II | 2023-10-18 |
| K230249 | Ikshana | Immersivetouch | LLZ | Class II | 2023-10-16 |
| K230370 | SpotLight/SpotLight Duo (with DLIR option) | Arineta , Ltd. | JAK | Class II | 2023-10-13 |
| K231642 | Veuron-Brain-pAb3 | Heuron Co., Ltd. | LLZ | Class II | 2023-10-13 |
| K231574 | Scenaria View 4.2 | FUJIFILM Healthcare Americas Corporation | JAK | Class II | 2023-10-12 |
| K222222 | Artemis, Artemis TPO, Artemis MX | Eigen | QTZ | Class II | 2023-10-12 |
| K232981 | Synq Software Version 1.3 | Synaptive Medical, Inc. | LNH | Class II | 2023-10-11 |
| K230220 | NeuViz 128 Multi-Slice CT Scanner System | Neusoft Medical Systems Co., Ltd. | JAK | Class II | 2023-10-11 |
| K232344 | Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR | GE Medical Systems SCS | OWB | Class II | 2023-10-11 |
| K230130 | Micromate Navi+ | Isys Medizintechnik GmbH | JAK | Class II | 2023-10-10 |
| K232760 | Swoop® Portable MR Imaging System® | Hyperfine, Inc. | LNH | Class II | 2023-10-06 |
| K231863 | ProBeam 360° Proton Therapy System v2.0 (Multiroom) | Varian Medical Systems, Inc. | LHN | Class II | 2023-10-06 |
| K230144 | Denti.AI Detect | Denti.Ai Technology, Inc. | MYN | Class II | 2023-10-06 |
| K231001 | DeepTek CXR Analyzer v1.0 | Deeptek Medical Imaging Pvt, Ltd. | MYN | Class II | 2023-10-05 |
| K232367 | cmAngio® V1.0 | Curemetrix, Inc. | QIH | Class II | 2023-10-05 |
| K232704 | Clarius Ultrasound Scanner | Clarius Mobile Health Corp. | IYN | Class II | 2023-10-05 |
| K231398 | VUNO Med-DeepBrain | Vuno, Inc. | QIH | Class II | 2023-10-04 |
| K231025 | EFAI NeuroSuite CT ICH Assessment System | Ever Fortune.Ai, Co., Ltd. | QAS | Class II | 2023-10-04 |
| K231772 | V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | 2023-10-03 |
| K232762 | dS Breast Coil 7ch 1.5T | Invivo Corporation (Business Trade Name: Philips) | MOS | Class II | 2023-10-03 |
| K230085 | Lung-CAD | Imagen Technologies, Inc. | MYN | Class II | 2023-10-03 |
| K232712 | uMI Panorama | Shanghai United Imaging Healthcare Co., Ltd. | KPS | Class II | 2023-10-03 |
14,721 clearances in the Radiology panel. Data: openFDA.