Review Panel
Radiology FDA 510(k) Clearances & Devices
- Cleared Devices
- 14,721
- Product Codes (page)
- 29
- Latest Decision
- 2026-03-13
Clearances · page 4 of 148
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K252249 | Extremity CT Imaging System | Mars Bioimaging , Ltd. | JAK | Class II | 2026-03-13 |
| K251964 | Mimics Thoracic Planner | Materialise NV | LLZ | Class II | 2026-03-12 |
| K253185 | Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System | Carestream Health | IZL | Class II | 2026-03-11 |
| K253584 | Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension) | Canon Medical Systems Corporation | OWB | Class II | 2026-03-10 |
| K252353 | myray ProXIma X6 | Cefla S.C. | OAS | Class II | 2026-03-10 |
| K260595 | Sonosite iLOOK Ultrasound System | FUJIFILM Sonosite, Inc. | IYN | Class II | 2026-03-10 |
| K253413 | LiverMultiScan (v6.0) | Perspectum, Ltd. | LNH | Class II | 2026-03-09 |
| K253551 | VELYS Hip Navigation | Depuy Ireland UC | QIH | Class II | 2026-03-06 |
| K260167 | Bunkerhill Contrast AVC | BunkerHill Health | JAK | Class II | 2026-03-06 |
| K260166 | Bunkerhill Contrast CAC | BunkerHill Health | JAK | Class II | 2026-03-06 |
| K260169 | AV Cardiac CT | Philips Medical Systems Nederland B.V. | JAK | Class II | 2026-03-05 |
| K252538 | CEPHX3D | Orca Dental AI , Ltd. | QIH | Class II | 2026-03-05 |
| K251901 | Magnifico Open (100009900) | Esaote, S.p.A. | LNH | Class II | 2026-03-05 |
| K253898 | QT Scanner 2000 Model A | QT Imaging Holdings, Inc. | IYO | Class II | 2026-03-04 |
| K253818 | Annalise Enterprise | Harrison-AI Medical Pty, Ltd. | QAS | Class II | 2026-03-03 |
| K253593 | Clarius Ejection Fraction AI | Clarius Mobile Health Corp. | QIH | Class II | 2026-03-02 |
| K253535 | Ligence Heart | Ligence Uab | QIH | Class II | 2026-02-27 |
| K253578 | BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device | Aidoc Medical , Ltd. | QAS | Class II | 2026-02-26 |
| K260217 | AI Platform 2.2 (AIP002) | Exo Imaging | QIH | Class II | 2026-02-24 |
| K253714 | IntraSight Plus | Philips Image Guided Therapy Corporation | IYO | Class II | 2026-02-24 |
| K253486 | SKIA-Head (Model: SKIA-ST00) | Skia, Inc. | LLZ | Class II | 2026-02-23 |
| K260265 | MAGNETOM Flow.Ace; MAGNETOM Flow.Plus | Siemens Shenzhen Magnetic Resonance , Ltd. | LNH | Class II | 2026-02-23 |
| K253648 | Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including Upgrades | Philips Medical Systems Nederland B.V. | LNH | Class II | 2026-02-23 |
| K253244 | AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini) | Poskom Co., Ltd. | IZL | Class II | 2026-02-23 |
| K252500 | CARA System | Cara Medical, Ltd. | OWB | Class II | 2026-02-20 |
| K260308 | TrueFit Bolus | Adaptiiv Medical Technologies, Inc. | MUJ | Class II | 2026-02-19 |
| K252002 | Monaco RTP System (6.3) | Elekta Solutions AB | MUJ | Class II | 2026-02-19 |
| K260205 | AS Software Version Asera | AS Software, LLC | LLZ | Class II | 2026-02-19 |
| K253564 | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES) | Shanghai United Imaging Healthcare Co., Ltd. | KPS | Class II | 2026-02-13 |
| K252084 | AI4CMR v2.0 | Ai4medimaging Medical Solutions S.A. | QIH | Class II | 2026-02-11 |
| K251992 | ArmSure Fluoroscopic Positioning System | Savfe Co. , Ltd. | OWB | Class II | 2026-02-11 |
| K253049 | Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | Class II | 2026-02-11 |
| DEN250007 | Delivery Date AI | Ultrasound AI | SHE | Class II | 2026-02-11 |
| K254016 | MI View&GO | Siemens Medical Solutions USA, Inc. | QIH | Class II | 2026-02-10 |
| K260119 | SpaceOAR Vue System (SV-2101) | Boston Scientific Corporation | OVB | Class II | 2026-02-10 |
| K252179 | GEM Flex Coil 16-L Array, 1.5T Receive Only; GEM Flex Coil 16-M Array, 1.5T Receive Only; GEM Flex Coil 16-S Array, 1.5T Receive Only | Shenzhen RF Tech Co., Ltd. | MOS | Class II | 2026-02-10 |
| K251577 | LAIA XR | Augmented Reality Software S.L. | LLZ | Class II | 2026-02-06 |
| K253221 | Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro) | Eieling Technology (Shenzhen) Limited | IYO | Class II | 2026-02-06 |
| K253780 | SIGNA Bolt | Ge Medical Systems, LLC | LNH | Class II | 2026-02-06 |
| K251474 | Median LCS (internal name) / eyonis LCS (trade name) (1.0) | Median Technologies | QDQ | Class II | 2026-02-06 |
| K253927 | LiveMedica Enterprise PACS | Live Medica, LLC | LLZ | Class II | 2026-02-06 |
| K253959 | Primevision 3D | Dentsply Sirona | OAS | Class II | 2026-02-05 |
| K253779 | SIGNA Sprint Select | Ge Medical Systems, LLC | LNH | Class II | 2026-02-05 |
| K252649 | TAP2D | Nano-X Imaging , Ltd. | IZF | Class II | 2026-02-02 |
| K251769 | RevealAI-Lung | Precision Medical Ventures, Inc. Dba Revealdx | POK | Class II | 2026-01-30 |
| K252496 | Neurophet AQUA AD Plus | Neurophet., Inc. | QIH | Class II | 2026-01-29 |
| K252091 | Surgical Reality Viewer | Medicalvr B.V. | QIH | Class II | 2026-01-29 |
| K251306 | Seg Pro V3 (RT-300) | Ever Fortune.Ai, Co., Ltd. | QKB | Class II | 2026-01-28 |
| K251195 | BriefCase-Triage | Aidoc Medical , Ltd. | QAS | Class II | 2026-01-27 |
| K253499 | Ascent3T Neonatal Magnetic Resonance Imaging System | Eyas Medical Imaging, Inc. | LNH | Class II | 2026-01-26 |
| K251351 | AccuContour 4.0 | Manteia Technologies Co., Ltd. | QKB | Class II | 2026-01-23 |
| K253738 | 3.0T AIR 32CH HNA | Ge Healthcare Coils (Usa Instruments, Inc.) | MOS | Class II | 2026-01-23 |
| K253057 | AI-Rad Companion Brain MR | Siemens Healthcare GmbH | QIH | Class II | 2026-01-22 |
| K253735 | AV Vascular | Philips Medical Systems Nederland B.V. | QIH | Class II | 2026-01-22 |
| K252977 | Halcyon, Ethos Radiotherapy System (5.0) | Varian Medical Systems, Inc. | IYE | Class II | 2026-01-21 |
| K253597 | Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System | Canon Medical Systems Corporation | IYN | Class II | 2026-01-20 |
| K253173 | uCT 780 with uWS-CT-Dual Energy Analysis | Shanghai United Imaging Healthcare Co., Ltd. | JAK | Class II | 2026-01-20 |
| K250954 | DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector | Carestream Health | KPR | Class II | 2026-01-20 |
| K254186 | Azurion R3.1 | Philips Medical Systems B.V. | OWB | Class II | 2026-01-16 |
| K252634 | Imagine® Enterprise Suite | Softlink International Private Limited | QIH | Class II | 2026-01-16 |
| K251934 | qXR-Detect | Qure.Ai Technologies | MYN | Class II | 2026-01-16 |
| K252188 | EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy) | Elekta Solutions AB | IYE | Class II | 2026-01-15 |
| K252934 | Diagnocat | DGNCT, LLC | MYN | Class II | 2026-01-15 |
| K253023 | BIOGRAPH One | Siemens Healthineers AG | OUO | Class II | 2026-01-15 |
| K254190 | dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS HeadNeck 3.0T | Philips Medical Systems Nederland B.V. | MOS | Class II | 2026-01-14 |
| K254010 | ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface | Brainlab SE | IYE | Class II | 2026-01-14 |
| K252579 | Orthoscan TAU MVP Mini C-Arm System | Ziehm-Orthoscan, Inc. | OXO | Class II | 2026-01-14 |
| K254001 | VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464) | Spectrum Dynamics Medical, Ltd. | KPS | Class II | 2026-01-13 |
| K253784 | 3DICOM MD Cloud | Singular Health Pty, Ltd. | LLZ | Class II | 2026-01-08 |
| K253639 | View | GE Healthcare | LLZ | Class II | 2026-01-08 |
| K253370 | LOGIQ Totus | GE Medical Systems Ultrasound and Primary Care Diagnostics | IYN | Class II | 2026-01-08 |
| K253009 | DS Core Detect | Dentsply Sirona, Inc. | MYN | Class II | 2026-01-07 |
| K253366 | LOGIQ Fortis | GE Medical Systems Ultrasound and Primary Care Diagnostics | IYN | Class II | 2026-01-07 |
| K252970 | BriefCase-Triage: CARE Multi-triage CT Body | Aidoc Medical , Ltd. | QAS | Class II | 2026-01-07 |
| K253008 | maiLink | Maihub Corp. | LLZ | Class II | 2026-01-05 |
| K252988 | ChartCheck (RADCH V1.6) | Radformation, Inc. | IYE | Class II | 2026-01-05 |
| K252018 | HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | 2026-01-05 |
| K253532 | TruSPECT Processing Station | Spectrum Dynamics Medical, Ltd. | QIH | Class II | 2025-12-30 |
| K253844 | AnyScan 3.0 NM Scanner Family | Mediso Medical Imaging Systems, Ltd. | KPS | Class II | 2025-12-30 |
| K253091 | ART-Plan+ (v3.1.0) | Therapanacea Sas | MUJ | Class II | 2025-12-23 |
| K253122 | Sim&Size | Sim&Cure | PZO | Class II | 2025-12-23 |
| K252379 | AIR Recon DL | Ge Medical Systems, LLC | LNH | Class II | 2025-12-23 |
| K251268 | Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP) | Edan Instruments, Inc. | IYN | Class II | 2025-12-23 |
| K250959 | BioticsAI | Bioticsai, Inc. | IYN | Class II | 2025-12-22 |
| K252068 | MC2 Portable X-ray System | Oxos Medical | OWB | Class II | 2025-12-22 |
| K252109 | RayStation (2024A SP3) | RaySearch Laboratories AB (PUBL) | MUJ | Class II | 2025-12-22 |
| K252557 | Lumify Diagnostic Ultrasound System | Philips Ultrasound, LLC | IYN | Class II | 2025-12-22 |
| K252856 | PeekMed web | Peek Health, S.A. | QIH | Class II | 2025-12-22 |
| K252029 | AI-CVD | HeartLung Corporation | QIH | Class II | 2025-12-19 |
| K250976 | Airbile-100 | Poskom Co., Ltd. | IZL | Class II | 2025-12-19 |
| K251037 | Rectal Applicator | Nucletron B.V. | JAQ | Class II | 2025-12-19 |
| K252670 | Alzevita | TOPIA MEDTECH LIMITED | QIH | Class II | 2025-12-19 |
| K251730 | LIA Console (542-7) | Leadoptik, Inc. | NQQ | Class II | 2025-12-19 |
| K252838 | MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise | Siemens Healthcare GmbH | LNH | Class II | 2025-12-19 |
| K252780 | LCD Monitor (CL1902A, CL2103F) | Shenzhen Beacon Display Technology Co., Ltd. | PGY | Class II | 2025-12-19 |
| K252863 | ClearCalc Model RADCA V2.6 | Radformation, Inc. | MUJ | Class II | 2025-12-19 |
| K250914 | MediAI-BA | Crescom Co., Ltd. | QIH | Class II | 2025-12-18 |
| K252071 | RefleXion Medical Radiotherapy System, Reflexion X2 | Reflexion Medical, Inc. | QVA | Class II | 2025-12-18 |
| K252235 | PVAD IQ Software | Ultrasight , Ltd. | QIH | Class II | 2025-12-18 |
| K252922 | Neosoma Brain Mets | Neosoma, Inc. | QIH | Class II | 2025-12-17 |
14,721 clearances in the Radiology panel. Data: openFDA.