Review Panel
Radiology FDA 510(k) Clearances & Devices
- Cleared Devices
- 14,721
- Product Codes (page)
- 33
- Latest Decision
- 2023-09-29
Clearances · page 15 of 148
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K230045 | HipCheck | Stryker Corp. | QIH | Class II | 2023-09-29 |
| K230187 | Terran NM-101 | Terran Biosciences, Inc. | LNH | Class II | 2023-09-29 |
| K231837 | Brainomix 360 Triage LVO | Brainomix Limited | QAS | Class II | 2023-09-28 |
| K232336 | ES Series V2 | E-Scopics | IYN | Class II | 2023-09-26 |
| K232617 | ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | IYN | Class II | 2023-09-26 |
| K230252 | OFIX MIS App | Orthofix US, LLC | LLZ | Class II | 2023-09-26 |
| K231928 | EFAI RTSUITE CT HCAP-Segmentation System | Ever Fortune.Ai, Co., Ltd. | QKB | Class II | 2023-09-25 |
| K231384 | Annalise Enterprise CTB Triage Trauma | Annalise-Ai Pty , Ltd. | QAS | Class II | 2023-09-22 |
| K231149 | qXR-CTR | Qure.Ai Technologies | QIH | Class II | 2023-09-22 |
| K231767 | Annalise Enterprise CTB Triage Trauma | Annalise-Ai Pty , Ltd. | QAS | Class II | 2023-09-22 |
| K223659 | Jazz | Ai Medical AG | LLZ | Class II | 2023-09-22 |
| K231678 | Overjet Periapical Radiolucency Assist | Overjet, Inc. | MYN | Class II | 2023-09-21 |
| K232569 | CAREMIBRAIN | General Equipment For Medical Imaging, S.A. | KPS | Class II | 2023-09-21 |
| K231385 | Rology Teleradiology Platform (v.1.22.1103) | Rology, Inc. | LLZ | Class II | 2023-09-20 |
| K231281 | Aquilion Serve (TSX-307A/1) V1.3 | Canon Medical Systems Corporation | JAK | Class II | 2023-09-19 |
| K232178 | GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series) | DRGEM Corporation | KPR | Class II | 2023-09-19 |
| K230066 | Carnation series Diagnostic Ultrasound System | Shenzhen Wisonic Medical Technology Co. , Ltd. | IYN | Class II | 2023-09-15 |
| K231576 | cNeuro cPET | Combinostics OY | KPS | Class II | 2023-09-14 |
| K232189 | OrionXR | Hoth Intelligence, Inc. | LLZ | Class II | 2023-09-14 |
| K231353 | AccuCTP Pro | ArteryFlow Technology Co., Ltd. | LLZ | Class II | 2023-09-14 |
| K232487 | Provecta 3D Prime and Provecta 3D Prime Ceph | Durr Dental SE | OAS | Class II | 2023-09-14 |
| K220034 | NEUROShield | In-Med Prognostics L3c | LLZ | Class II | 2023-09-14 |
| K223811 | Lung-CAD | Imagen Technologies, Inc. | MYN | Class II | 2023-09-13 |
| K222938 | Ablation-fit | R.A.W. S.R.L | QTZ | Class II | 2023-09-12 |
| K232459 | Velacur | Sonic Incytes | IYO | Class II | 2023-09-12 |
| K231748 | Cartesion Prime (PCD-1000A/3) V10.15 | Canon Medical Systems Corporation | KPS | Class II | 2023-09-12 |
| K231317 | TrueBeam, TrueBeam STx, Edge, VitalBeam | Varian Medical Systems, Inc. | IYE | Class II | 2023-09-12 |
| K232526 | XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5 | Canon Medical Systems Corporation | JAA | Class II | 2023-09-12 |
| K231892 | Definium Pace Select | Ge Hualun Medical Systems Co. , Ltd. | KPR | Class II | 2023-09-12 |
| K231283 | SiteRite 9 Ultrasound System | Bard Access Systems, Inc. (C.R. Bard, Inc.) | IYO | Class II | 2023-09-11 |
| K232400 | VariSeed (v10) | Varian Medical Systems | MUJ | Class II | 2023-09-08 |
| K223621 | DeepXray | Alpha Intelligence Manifolds, Inc. | QIH | Class II | 2023-09-08 |
| K232166 | PreXion3D Expedition | Prexion Corporation | OAS | Class II | 2023-09-08 |
| K232386 | ILUMIEN OPTIS System, OPTIS Integrated System, OPTIS Mobile System, with AptiVue Imaging Software version E.6 | ABBOTT MEDICAL | NQQ | Class II | 2023-09-08 |
| K232482 | MAGNETOM Viato.Mobile | Siemens Medical Solutions USA, Inc. | LNH | Class II | 2023-09-06 |
| K232361 | Promaxo MRI System II | Promaxo, Inc. | LNH | Class II | 2023-09-05 |
| K232021 | Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T | Philips Healthcare (Suzhou) Co., Ltd. | MOS | Class II | 2023-09-01 |
| K230918 | MasterX 800 Series | Medicatech USA | MQB | Class II | 2023-09-01 |
| K231047 | UniSyn Molecular Imaging (6-3-1) | Convergent Imaging Solutions | LLZ | Class II | 2023-09-01 |
| K232287 | RAYSCAN a-Expert3D | Ray Co., Ltd. | OAS | Class II | 2023-08-31 |
| K230155 | Mick Valencia Applicator Set | Mick Radio-Nuclear Instruments, Inc. | JAQ | Class II | 2023-08-30 |
| K230355 | Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | LNH | Class II | 2023-08-30 |
| K231656 | Brainomix 360 e-MRI | Brainomix Limited | LLZ | Class II | 2023-08-30 |
| K230221 | QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy) | Versant Medical Physics and Radiation Safety | IYX | Class I | 2023-08-28 |
| K231676 | CALLISTO eye | Carl Zeiss Meditec, AG | NFJ | Class II | 2023-08-28 |
| K223639 | VisAble.IO | Techsomed | QTZ | Class II | 2023-08-28 |
| K223180 | AIRAscore | Airamed GmbH | LLZ | Class II | 2023-08-25 |
| K222972 | BioProtect Balloon Implant System | Bioprotect, Ltd. | OVB | Class II | 2023-08-25 |
| K230899 | qXR-PTX-PE | Qure.Ai Technologies | QFM | Class II | 2023-08-22 |
| K231503 | CUPTIMIZE Advanced | DePuy Orthopaedics, Inc. | LLZ | Class II | 2023-08-22 |
| DEN220052 | BrachyGel Vaginal Hydrogel Packing System | Brachyfoam, Inc. D/B/A Advaray | QXR | Class II | 2023-08-22 |
| K231731 | Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4 | Mcgovern Medical School | KPS | Class II | 2023-08-21 |
| K232185 | SM-IV | Sedecal., Sa. | IZL | Class II | 2023-08-21 |
| K231026 | 12MP Color LCD Monitor C1216W, C12*** (* = 0 to 9, A to Z or blank, and the difference among models means the product is named according to different appearance colors and customer models) | Shenzhen Beacon Display Technology Co., Ltd. | PGY | Class II | 2023-08-18 |
| K231085 | 1.5T HD T/R Knee Array (10-F34127) | Shenzhen RF Tech Co., Ltd. | MOS | Class II | 2023-08-18 |
| K230871 | EXTRON 5; EXTRON 7 | DRTECH Corporation | OWB | Class II | 2023-08-17 |
| K230581 | TOPA12 Portable X-ray Unit | Neuf, Inc. | IZL | Class II | 2023-08-16 |
| K232127 | 21HQ513D, 32HL512D, 31HN713D, 32HQ713D | Lg Electronics.Inc | PGY | Class II | 2023-08-15 |
| K231301 | Vscan Air | GE Medical Systems Ultrasound and Primary Care Diagnostics | IYN | Class II | 2023-08-15 |
| K231094 | Annalise Enterprise CTB Triage-OH | Annalise-Ai Pty , Ltd. | QAS | Class II | 2023-08-15 |
| K223660 | SaintView | Inviz Corporation | LLZ | Class II | 2023-08-14 |
| K231420 | Aura 10 PET/CT | Xeos Medical | QXL | Class II | 2023-08-10 |
| K232100 | Efai Pacs Picture Archiving and Communication System Pro | Ever Fortune.Ai, Co., Ltd. | LLZ | Class II | 2023-08-08 |
| K232058 | YosemiteView 4343W/YosemiteView 3643W | Careray Digital Medical Technology Co., Ltd. | MQB | Class II | 2023-08-03 |
| K223133 | VisiRad XR | Imidex, Inc. | MYN | Class II | 2023-08-03 |
| K232030 | Ingenia Elition R5.7.1 SP4 MR Systems | Philips Medical Systems Nederland B.V. | LNH | Class II | 2023-08-02 |
| K223689 | Disposable Needle Guides and Grids | Advance Medical Designs, Inc. | ITX | Class II | 2023-08-02 |
| K230162 | uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy Analysis | Shanghai United Imaging Healthcare Co., Ltd. | JAK | Class II | 2023-08-01 |
| K231959 | EXPD 4357; EXPD 4357P | DRTECH Corporation | MQB | Class II | 2023-08-01 |
| K232088 | Altris IMS | Altris, Inc. | NFJ | Class II | 2023-07-31 |
| K230074 | Rapid Aneurysm Triage and Notification | Ischemaview, Inc. | QFM | Class II | 2023-07-27 |
| K231195 | Brainomix 360 Triage ICH | Brainomix Limited | QAS | Class II | 2023-07-27 |
| K231572 | uMI Panorama | Shanghai United Imaging Healthcare Co., Ltd. | KPS | Class II | 2023-07-26 |
| K231577 | MOBILETT Impact | Siemens Medical Solutions | IZL | Class II | 2023-07-25 |
| K230365 | Sonio Detect | Sonio | IYN | Class II | 2023-07-25 |
| K230576 | IDENTIFY | Varian Medical Systems, Inc. | IYE | Class II | 2023-07-25 |
| K230913 | ANDI | Imeka Solutions, Inc. | QIH | Class II | 2023-07-25 |
| K230540 | Patient Specific Planning Solution 3D Bone Models | Biomet Manufacturing Corp | LLZ | Class II | 2023-07-25 |
| K223347 | UltraSight AI Guidance | Ultrasight, Inc. | QJU | Class II | 2023-07-24 |
| K223322 | Argus Cognitive ReVISION Software | Argus Cognitive, Inc. | LLZ | Class II | 2023-07-24 |
| K230150 | OptimMRI | Rebrain, Sas | QIH | Class II | 2023-07-21 |
| K230039 | uOmnispace | Shanghai United Imaging Healthcare Co., Ltd. | QIH | Class II | 2023-07-20 |
| K223484 | IGAR System (1001.A) | Insight Medbotics, Inc. | MOS | Class II | 2023-07-20 |
| K223834 | AccuCheck | Manteia Technologies Co., Ltd. | IYE | Class II | 2023-07-20 |
| K230787 | Oscar 15 & Oscar 15i | Genoray Co., Ltd. | OWB | Class II | 2023-07-20 |
| K231796 | Grreen X 12 (Model: PHT-75CHS) | VATECH Co., Ltd. | OAS | Class II | 2023-07-19 |
| K231157 | syngo.CT Lung CAD (Version VD30) | Siemens Healthcare GmbH | OEB | Class II | 2023-07-19 |
| K222683 | Fibroid Mapping Reviewer Application (FMRA) | Nesa Medtech Private Limited | LLZ | Class II | 2023-07-17 |
| K230016 | Cercare Medical Neurosuite | Cercare Medical A/S | LLZ | Class II | 2023-07-14 |
| K223106 | Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking (2.0);BOLD MRI Mapping (1.0);Image Fusion Angio (1.0) | Brainlab AG | QIH | Class II | 2023-07-14 |
| K231757 | Ez3D-i /E3 | Ewoosoft Co., Ltd. | QIH | Class II | 2023-07-14 |
| K231041 | JiveX (Model Number / Release: 5.4) | Visus Health IT GmbH | LLZ | Class II | 2023-07-14 |
| K223290 | CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02) | Sentiar, Inc. | LLZ | Class II | 2023-07-14 |
| K223424 | Spine Auto Views | GE Medical Systems SCS | JAK | Class II | 2023-07-13 |
| K231351 | Chondral Quant | Siemens Medical Soultions USA, Inc. | LLZ | Class II | 2023-07-13 |
| K230611 | X80 / RADiant / PhotoElectric Therapy System (RADiant Aura) | Xstrahl, Ltd. | JAD | Class II | 2023-07-13 |
| K231833 | Biograph Vision.X and Biograph Vision.X Edge | Siemens Medical Solutions USA, Inc. | KPS | Class II | 2023-07-13 |
| K223261 | Open Rib | Canon Medical Informatics, Inc. | JAK | Class II | 2023-07-13 |
| K223125 | XR90 (XR90-SYS) | Mediview Xr, Inc. | LLZ | Class II | 2023-07-13 |
| K223426 | ECHELON Synergy MRI system | Fujifilm Healthcare Corporation | LNH | Class II | 2023-07-13 |
14,721 clearances in the Radiology panel. Data: openFDA.