Subpart B—Diagnostic Devices
FDA submissions for Subpart B—Diagnostic Devices in the Radiology (RA) review panel, including product codes, regulations, and recent device decisions.
Section range: §§ 892.1000–892.2100
CFR Part: 892
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | 892.1000 | 2 | 1098 |
| LNI | System, Nuclear Magnetic Resonance Spectroscopic | 892.1000 | 2 | 10 |
| MOS | Coil, Magnetic Resonance, Specialty | 892.1000 | 2 | 487 |
| OIM | Mri Disposable Kit | 892.1000 | 2 | 0 |
| PCS | Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox | 892.1001 | 2 | 3 |
| IYX | Camera, Scintillation (Gamma) | 892.1100 | 1 | 130 |
| IZC | Camera, Positron | 892.1110 | 1 | 0 |
| JAN | Counter, Whole Body, Nuclear | 892.1130 | 1 | 0 |
| KGI | Densitometer, Bone | 892.1170 | 2 | 146 |
| SAO | Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density | 892.1171 | 2 | 2 |
| MUA | Bone Sonometer | 892.1180 | 2 | 17 |
| KPS | System, Tomography, Computed, Emission | 892.1200 | 2 | 470 |
| OUO | Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance | 892.1200 | 2 | 14 |
| QXL | Cabinet, Emission Computed Tomography System | 892.1200 | 2 | 1 |
| JAO | Scanner, Fluorescent | 892.1220 | 2 | 2 |
| IYW | Scanner, Rectilinear, Nuclear | 892.1300 | 1 | 4 |
| JWM | System, Tomographic, Nuclear | 892.1310 | 2 | 17 |
| IZD | Probe, Uptake, Nuclear | 892.1320 | 1 | 30 |
| JAM | Scanner, Whole Body, Nuclear | 892.1330 | 1 | 3 |
| IYZ | Bed, Scanning, Nuclear | 892.1350 | 1 | 12 |
| KPT | Calibrator, Dose, Radionuclide | 892.1360 | 2 | 32 |
| IYP | Phantom, Anthropomorphic, Nuclear | 892.1370 | 1 | 3 |
| IYQ | Phantom, Flood Source, Nuclear | 892.1380 | 1 | 0 |
| IYT | System, Rebreathing, Radionuclide | 892.1390 | 2 | 48 |
| IXD | Source, Calibration, Sealed, Nuclear | 892.1400 | 1 | 2 |
| IYY | Synchronizer, Electrocardiograph, Nuclear | 892.1410 | 1 | 3 |
| JAR | Phantom, Test-Pattern, Radionuclide | 892.1420 | 1 | 0 |
| JAF | Monitor, Ultrasonic, Nonfetal | 892.1540 | 2 | 38 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 892.1550 | 2 | 1159 |
| NCS | System, Imaging, Holography, Acoustic | 892.1550 | 2 | 3 |
| PSV | Ultrasound Bronchoscope | 892.1550 | 2 | 3 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 892.1560 | 2 | 892 |
| LWI | Ultrasound, Sinus | 892.1560 | 2 | 4 |
| NQQ | System, Imaging, Optical Coherence Tomography (Oct) | 892.1560 | 2 | 45 |
| OIJ | Biopsy Needle Guide Kit | 892.1560 | 2 | 0 |
| QJG | Device System, Imaging, Tympanic Membrane And Middle Ear | 892.1560 | 2 | 2 |
| SGH | Ultrasound Imaging For Vascular Access For Hemodialysis | 892.1560 | 2 | 1 |
| ITX | Transducer, Ultrasonic, Diagnostic | 892.1570 | 2 | 409 |
| MUI | Media, Coupling, Ultrasound | 892.1570 | 2 | 32 |
| OQQ | Diagnostic Ultrasonic Transducer, Robotic | 892.1570 | 2 | 1 |
| OUJ | High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist | 892.1570 | 2 | 4 |
| PSW | High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid | 892.1570 | 2 | 7 |
| SGJ | Ultrasound Imaging System For Acquiring Images At Home By Lay Users | 892.1590 | 2 | 1 |
| IZI | System, X-Ray, Angiographic | 892.1600 | 2 | 197 |
| QHA | X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device | 892.1600 | 2 | 7 |
| IZS | Aperture, Radiographic | 892.1610 | 2 | 1 |
| IZT | Cone, Radiographic | 892.1610 | 2 | 1 |
| IZW | Collimator, Automatic, Radiographic | 892.1610 | 2 | 23 |
| IZX | Collimator, Manual, Radiographic | 892.1610 | 2 | 17 |
| KPW | Device, Beam Limiting, X-Ray, Diagnostic | 892.1610 | 2 | 16 |
| IZJ | Camera, X-Ray, Fluorographic, Cine Or Spot | 892.1620 | 2 | 12 |
| IXK | System, Imaging, X-Ray, Electrostatic | 892.1630 | 2 | 14 |
| JAC | System, X-Ray, Film Marking, Radiographic | 892.1640 | 1 | 18 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 892.1650 | 2 | 299 |
| OII | Arthrogram Tray | 892.1650 | 2 | 0 |
| OIK | Radiology Dental Tray | 892.1650 | 2 | 0 |
| OWB | Interventional Fluoroscopic X-Ray System | 892.1650 | 2 | 316 |
| OXO | Image-Intensified Fluoroscopic X-Ray System, Mobile | 892.1650 | 2 | 81 |
| QHY | Solid State Fluoroscopic X-Ray Imager | 892.1650 | 2 | 0 |
| RCC | C-Arm Fluoroscopic X-Ray System | 892.1650 | 2 | 0 |
| JAB | System, X-Ray, Fluoroscopic, Non-Image-Intensified | 892.1660 | 2 | 2 |
| IXL | Device, Spot-Film | 892.1670 | 2 | 13 |
| KPR | System, X-Ray, Stationary | 892.1680 | 2 | 355 |
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 892.1680 | 2 | 421 |
| MWP | Cabinet, X-Ray System | 892.1680 | 2 | 27 |
| OIO | Radiographic Contrast Tray | 892.1680 | 2 | 0 |
| OIP | Radiology-Diagnostic Kit | 892.1680 | 2 | 0 |
| IZO | Generator, High-Voltage, X-Ray, Diagnostic | 892.1700 | 1 | 163 |
| IZH | System, X-Ray, Mammographic | 892.1710 | 2 | 176 |
| POY | Post Breast Biopsy Hemostatic Breast Compression Device | 892.1710 | 2 | 1 |
| MUE | Full Field Digital, System, X-Ray, Mammographic | 892.1715 | 2 | 59 |
| IZL | System, X-Ray, Mobile | 892.1720 | 2 | 234 |
| IZG | System, X-Ray, Photofluorographic | 892.1730 | 2 | 7 |
| OIL | Discography Kit | 892.1730 | 2 | 0 |
| IZF | System, X-Ray, Tomographic | 892.1740 | 2 | 42 |
| JAK | System, X-Ray, Tomography, Computed | 892.1750 | 2 | 817 |
| OAS | X-Ray, Tomography, Computed, Dental | 892.1750 | 2 | 131 |
| SFV | X-Ray, Computed Tomography, Cone-Beam | 892.1750 | 2 | 1 |
| ITY | Assembly, Tube Housing, X-Ray, Diagnostic | 892.1760 | 1 | 40 |
| IYB | Tube Mount, X-Ray, Diagnostic | 892.1770 | 1 | 40 |
| HBK | Chair, Pneumoencephalographic | 892.1820 | 2 | 0 |
| KXH | Cradle, Patient, Radiologic | 892.1830 | 1 | 9 |
| IWZ | Film, Radiographic | 892.1840 | 1 | 34 |
| LQA | Media, Reusable Image | 892.1840 | 1 | 1 |
| IXA | Cassette, Radiographic Film | 892.1850 | 2 | 51 |
| KPX | Changer, Radiographic Film/Cassette | 892.1860 | 2 | 26 |
| IZP | Programmer, Changer, Film/Cassette, Radiographic | 892.1870 | 2 | 10 |
| IXY | Holder, Radiographic Cassette, Wall-Mounted | 892.1880 | 1 | 21 |
| IXC | Illuminator, Radiographic-Film | 892.1890 | 1 | 18 |
| JAG | Illuminator, Radiographic-Film, Explosion-Proof | 892.1890 | 1 | 0 |
| EGT | Controller, Temperature, Radiographic | 892.1900 | 2 | 0 |
| EGW | Dryer, Film, Radiographic | 892.1900 | 2 | 2 |
| EGY | Processor, Radiographic-Film, Automatic, Dental | 892.1900 | 2 | 9 |
| IXW | Processor, Radiographic-Film, Automatic | 892.1900 | 2 | 83 |
| IXX | Processor, Cine Film | 892.1900 | 2 | 6 |
| IXJ | Grid, Radiographic | 892.1910 | 1 | 15 |
| IWY | Holder, Head, Radiographic | 892.1920 | 1 | 10 |
| IWN | Cassette, Measurement, Ardran-Crooks | 892.1940 | 1 | 1 |
| IXF | Test-Pattern, Radiographic | 892.1940 | 1 | 5 |
| IXH | Camera, Focal Spot, Radiographic | 892.1940 | 1 | 2 |
| LHO | Instrument, Quality-Assurance, Radiologic | 892.1940 | 1 | 8 |
| SHN | Calibration Software For Radiology Displays | 892.1940 | 1 | 1 |
| IXG | Phantom, Anthropomorphic, Radiographic | 892.1950 | 1 | 4 |
| EAM | Screen, Intensifying, Radiographic | 892.1960 | 1 | 35 |
| QHX | Fluoroscopic X-Ray Image Intensifier | 892.1960 | 1 | 0 |
| IXO | Synchronizer, Ecg / Respirator, Radiographic | 892.1970 | 1 | 4 |
| IXQ | Table, Radiographic, Stationary Top | 892.1980 | 2 | 27 |
| IXR | Table, Radiographic, Tilting | 892.1980 | 2 | 77 |
| IZZ | Table, Radiographic, Non-Tilting, Powered | 892.1980 | 2 | 29 |
| KXJ | Table, Radiologic | 892.1980 | 2 | 31 |
| LEK | Transilluminator (Diaphanoscope) | 892.1990 | 3 | 0 |
| LMB | Device, Digital Image Storage, Radiological | 892.2010 | 1 | 55 |
| NFF | Device, Storage, Images, Ophthalmic | 892.2010 | 1 | 1 |
| LMD | System, Digital Image Communications, Radiological | 892.2020 | 1 | 142 |
| NFG | Device, Communications, Images, Ophthalmic | 892.2020 | 1 | 0 |
| LMA | Digitizer, Image, Radiological | 892.2030 | 2 | 61 |
| NFH | Digitizer, Images, Ophthalmic | 892.2030 | 2 | 0 |
| LMC | Camera, Multi Format, Radiological | 892.2040 | 2 | 121 |
| NFI | Device, Hardcopy, Images, Ophthalmic | 892.2040 | 2 | 0 |
| LLZ | System, Image Processing, Radiological | 892.2050 | 2 | 2263 |
| NWE | Colon Computed Tomography System, Computer Aided Detection | 892.2050 | 2 | 4 |
| OEB | Lung Computed Tomography System, Computer-Aided Detection | 892.2050 | 2 | 19 |
| OMJ | Chest X-Ray Computer Aided Detection | 892.2050 | 2 | 1 |
| PGY | Display, Diagnostic Radiology | 892.2050 | 2 | 134 |
| QIH | Automated Radiological Image Processing Software | 892.2050 | 2 | 282 |
| QKB | Radiological Image Processing Software For Radiation Therapy | 892.2050 | 2 | 46 |
| QTZ | Radiological Image Processing Software For Ablation Therapy Planning And Evaluation | 892.2050 | 2 | 7 |
| QZL | Post-Ablation Tissue Response Prediction Software | 892.2052 | 2 | 2 |
| QVD | Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan | 892.2055 | 2 | 1 |
| POK | Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer | 892.2060 | 2 | 21 |
| MYN | Analyzer, Medical Image | 892.2070 | 2 | 47 |
| QAS | Radiological Computer-Assisted Triage And Notification Software | 892.2080 | 2 | 83 |
| QFM | Radiological Computer-Assisted Prioritization Software For Lesions | 892.2080 | 2 | 39 |
| QWO | Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease. | 892.2085 | 2 | 4 |
| QBS | Radiological Computer Assisted Detection/Diagnosis Software For Fracture | 892.2090 | 2 | 9 |
| QDQ | Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer | 892.2090 | 2 | 32 |
| QJU | Image Acquisition And/Or Optimization Guided By Artificial Intelligence | 892.2100 | 2 | 7 |
Recent Devices
| Record | Device | Applicant | Decision Date |
|---|---|---|---|
| K252237 | EdgeFlow UW20 | Edgecare, Inc. | Apr 17, 2026 |
| K253502 | Critical Care Suite with Enteric Tube Positioning AI Algorithm | Ge Medical Systems, LLC | Apr 14, 2026 |
| K252587 | HD 8Ch Wrist Array | Shenzhen RF Tech Co., Ltd. | Apr 14, 2026 |
| K253930 | Overjet Iris Intelligent Imaging System | Overjet, Inc. | Apr 10, 2026 |
| K253689 | syngo Dynamics (VA41F) | Siemens Healthcare GmbH | Apr 10, 2026 |
| K253446 | AeroDR TX c02 | Dk Medical Systems Co., Ltd. | Apr 10, 2026 |
| K252708 | Relu Cloud | Relu BV | Apr 10, 2026 |
| K252548 | AI-Rad Companion Organs RT | Siemens Healthcare GmbH | Apr 10, 2026 |
| K252190 | DeepBT Detector-Plus | Aitewan Biomedical Technology, Inc. | Apr 10, 2026 |
| K260462 | RCT800 | Ray Co., Ltd. | Apr 9, 2026 |
| K254021 | Accuro XV | Rivanna Medical, Inc. | Apr 9, 2026 |
| K253862 | APERTO Lucent MRI System | Fujifilm Corporation | Apr 6, 2026 |
| K253288 | 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) | Esaote, S.p.A. | Apr 6, 2026 |
| K260524 | uMI Panvivo (uMI Panvivo LS); 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. | Apr 3, 2026 |
| K252709 | Wireless Probe Type Ultrasound Scanner | Xuzhou Yongkang Electronic Science Technology Co., Ltd. | Apr 2, 2026 |
| K252229 | BELLIGER ACE | Genoray Co., Ltd. | Apr 2, 2026 |
| K254015 | CoLumbo C-Spine | Smart Soft Healthcare AD | Apr 1, 2026 |
| K253582 | Medical Imaging Calibration Feature (MICF) | Apple, Inc. | Apr 1, 2026 |
| K252876 | GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Receive Only; GEM Flex Coil 16-S Array, 3.0T Receive Only | Shenzhen RF Tech Co., Ltd. | Apr 1, 2026 |
| K260093 | Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS) | VATECH Co., Ltd. | Mar 31, 2026 |
| K253029 | RW-1 | Mediott, Inc. | Mar 31, 2026 |
| K254207 | AiORTA - Plan v2.0 | ViTAA Medical Solutions, Inc. | Mar 30, 2026 |
| K253950 | Avatar Medical Vision | Avatar Medical | Mar 30, 2026 |
| K260746 | S-scan Open (100001800) | Esaote, S.p.A. | Mar 27, 2026 |
| K254161 | Automated Aortic Stenosis Software (AutoAS) | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | Mar 27, 2026 |
| K254099 | EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10 Diagnostic Ultrasound System; EVO XQ30 Diagnostic Ultrasound System; EVO XQ20 Diagnostic Ultrasound System; EVO XQ10 Diagnostic Ultrasound System; EVO QH30 Diagnostic Ultrasound System; EVO QH20 Diagnostic Ultrasound System; EVO QH10 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | Mar 27, 2026 |
| K253649 | Spectral CT Verida Family | Philips Medical Systems Technologies , Ltd. | Mar 27, 2026 |
| K253625 | Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | Mar 27, 2026 |
| K253595 | EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | Mar 27, 2026 |
| K253270 | Contour ProtégéAI+ | Mim Software, Inc. | Mar 27, 2026 |
| K252195 | ARTICOR planner | Artiness S.R.L | Mar 27, 2026 |
| K252148 | Butterfly Gestational Age Tool | Butterfly Network, Inc. | Mar 27, 2026 |
| K253796 | Lunit INSIGHT DBT (V1.2) | Lunit, Inc. | Mar 26, 2026 |
| K253775 | SwiftMR | Airs Medical, Inc. | Mar 26, 2026 |
| K260673 | LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 Power | GE Medical Systems Ultrasound and Primary Care Diagnostics | Mar 24, 2026 |
| K260087 | Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright | GE Medical Systems SCS | Mar 24, 2026 |
| K252421 | JLK-NCCT | JLK, Inc. | Mar 24, 2026 |
| K252099 | Trinias | Shimadzu Corporation | Mar 24, 2026 |
| K253686 | True Definition DL | Ge Healthcare Japan Corporation | Mar 23, 2026 |
| K252992 | CT Rembra RT; CT Areta RT; CT Rembra | Philips Healthcare (Suzhou) Co., Ltd. | Mar 23, 2026 |
| K260519 | Smart Fit TorsoCardiac 1.5T | Philips Healthcare (Suzhou) Co., Ltd. | Mar 20, 2026 |
| K253574 | SOMATOM X.cite; SOMATOM X.ceed | Siemens Medical Solutions USA, Inc. | Mar 20, 2026 |
| K253520 | Photonova Spectra, Photonova Spectra Select | Ge Medical Systems, LLC | Mar 20, 2026 |
| K251937 | nordicAudio (1.0) | Nordicneurolab AS | Mar 20, 2026 |
| K260509 | AutoContour (RADAC V5) | Radformation, Inc. | Mar 19, 2026 |
| K253614 | EchoNavigator R5.0 | Philips Medical Systems Nederland B.V. | Mar 17, 2026 |
| K253944 | Data Analysis Facilitation Suite (DAFS) | Voronoi Health Analytics Incorporated | Mar 16, 2026 |
| K252433 | Sonio Detect (v3) | Sonio | Mar 16, 2026 |
| K260479 | TheraSphere 360 Y-90 Management Platform | Boston Scientific Corporation | Mar 13, 2026 |
| K260078 | Aquilion ServeSP (TSX-307B) V2.0 | Canon Medical Systems Corporation | Mar 13, 2026 |
| K254277 | Embrace Neonatal MRI System | Aspect Imaging, Ltd. | Mar 13, 2026 |
| K253111 | Aeka Imaging | Good Methods Global, Inc. | Mar 13, 2026 |
| K252261 | InferCare RECIST | Beijing Infervision Healthcare Medical Technology Co., Ltd. | Mar 13, 2026 |
| K252249 | Extremity CT Imaging System | Mars Bioimaging , Ltd. | Mar 13, 2026 |
| K251964 | Mimics Thoracic Planner | Materialise NV | Mar 12, 2026 |
| K253185 | Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System | Carestream Health | Mar 11, 2026 |
| K260595 | Sonosite iLOOK Ultrasound System | FUJIFILM Sonosite, Inc. | Mar 10, 2026 |
| K253584 | Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension) | Canon Medical Systems Corporation | Mar 10, 2026 |
| K252353 | myray ProXIma X6 | Cefla S.C. | Mar 10, 2026 |
| K253413 | LiverMultiScan (v6.0) | Perspectum, Ltd. | Mar 9, 2026 |
| K260167 | Bunkerhill Contrast AVC | BunkerHill Health | Mar 6, 2026 |
| K260166 | Bunkerhill Contrast CAC | BunkerHill Health | Mar 6, 2026 |
| K253551 | VELYS Hip Navigation | Depuy Ireland UC | Mar 6, 2026 |
| K260169 | AV Cardiac CT | Philips Medical Systems Nederland B.V. | Mar 5, 2026 |
| K252538 | CEPHX3D | Orca Dental AI , Ltd. | Mar 5, 2026 |
| K251901 | Magnifico Open (100009900) | Esaote, S.p.A. | Mar 5, 2026 |
| K253898 | QT Scanner 2000 Model A | QT Imaging Holdings, Inc. | Mar 4, 2026 |
| K253818 | Annalise Enterprise | Harrison-AI Medical Pty, Ltd. | Mar 3, 2026 |
| K253593 | Clarius Ejection Fraction AI | Clarius Mobile Health Corp. | Mar 2, 2026 |
| K253535 | Ligence Heart | Ligence Uab | Feb 27, 2026 |
| K253578 | BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device | Aidoc Medical , Ltd. | Feb 26, 2026 |
| K260217 | AI Platform 2.2 (AIP002) | Exo Imaging | Feb 24, 2026 |
| K253714 | IntraSight Plus | Philips Image Guided Therapy Corporation | Feb 24, 2026 |
| K260265 | MAGNETOM Flow.Ace; MAGNETOM Flow.Plus | Siemens Shenzhen Magnetic Resonance , Ltd. | Feb 23, 2026 |
| 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. | Feb 23, 2026 |
| K253486 | SKIA-Head (Model: SKIA-ST00) | Skia, Inc. | Feb 23, 2026 |
| K253244 | AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini) | Poskom Co., Ltd. | Feb 23, 2026 |
| K252500 | CARA System | Cara Medical, Ltd. | Feb 20, 2026 |
| K260205 | AS Software Version Asera | AS Software, LLC | Feb 19, 2026 |
| 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. | Feb 13, 2026 |
| 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. | Feb 11, 2026 |
| K252084 | AI4CMR v2.0 | Ai4medimaging Medical Solutions S.A. | Feb 11, 2026 |
| K251992 | ArmSure Fluoroscopic Positioning System | Savfe Co. , Ltd. | Feb 11, 2026 |
| K254016 | MI View&GO | Siemens Medical Solutions USA, Inc. | Feb 10, 2026 |
| 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. | Feb 10, 2026 |
| K253927 | LiveMedica Enterprise PACS | Live Medica, LLC | Feb 6, 2026 |
| K253780 | SIGNA Bolt | Ge Medical Systems, LLC | Feb 6, 2026 |
| K253221 | Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro) | Eieling Technology (Shenzhen) Limited | Feb 6, 2026 |
| K251577 | LAIA XR | Augmented Reality Software S.L. | Feb 6, 2026 |
| K251474 | Median LCS (internal name) / eyonis LCS (trade name) (1.0) | Median Technologies | Feb 6, 2026 |
| K253959 | Primevision 3D | Dentsply Sirona | Feb 5, 2026 |
| K253779 | SIGNA Sprint Select | Ge Medical Systems, LLC | Feb 5, 2026 |
| K252649 | TAP2D | Nano-X Imaging , Ltd. | Feb 2, 2026 |
| K251769 | RevealAI-Lung | Precision Medical Ventures, Inc. Dba Revealdx | Jan 30, 2026 |
| K252496 | Neurophet AQUA AD Plus | Neurophet., Inc. | Jan 29, 2026 |
| K252091 | Surgical Reality Viewer | Medicalvr B.V. | Jan 29, 2026 |
| K251306 | Seg Pro V3 (RT-300) | Ever Fortune.Ai, Co., Ltd. | Jan 28, 2026 |
| K251195 | BriefCase-Triage | Aidoc Medical , Ltd. | Jan 27, 2026 |
| K253499 | Ascent3T Neonatal Magnetic Resonance Imaging System | Eyas Medical Imaging, Inc. | Jan 26, 2026 |
| K253738 | 3.0T AIR 32CH HNA | Ge Healthcare Coils (Usa Instruments, Inc.) | Jan 23, 2026 |
