| 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 (K254099) | Samsung Medison Co., Ltd. | 2026-03-27 |
| Butterfly Gestational Age Tool (K252148) | Butterfly Network, Inc. | 2026-03-27 |
| Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR (K253625) | Canon Medical Systems Corporation | 2026-03-27 |
| ARTICOR planner (K252195) | Artiness S.R.L | 2026-03-27 |
| SwiftMR (K253775) | Airs Medical, Inc. | 2026-03-26 |
| Lunit INSIGHT DBT (V1.2) (K253796) | Lunit, Inc. | 2026-03-26 |
| S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) (K253406) | Mevion Medical Systems, Inc. | 2026-03-25 |
| Trinias (K252099) | Shimadzu Corporation | 2026-03-24 |
| 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 (K260673) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2026-03-24 |
| JLK-NCCT (K252421) | JLK, Inc. | 2026-03-24 |
| Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright (K260087) | GE Medical Systems SCS | 2026-03-24 |
| True Definition DL (K253686) | Ge Healthcare Japan Corporation | 2026-03-23 |
| CT Rembra RT; CT Areta RT; CT Rembra (K252992) | Philips Healthcare (Suzhou) Co., Ltd. | 2026-03-23 |
| Smart Fit TorsoCardiac 1.5T (K260519) | Philips Healthcare (Suzhou) Co., Ltd. | 2026-03-20 |
| nordicAudio (1.0) (K251937) | Nordicneurolab AS | 2026-03-20 |
| Photonova Spectra, Photonova Spectra Select (K253520) | Ge Medical Systems, LLC | 2026-03-20 |
| SOMATOM X.cite; SOMATOM X.ceed (K253574) | Siemens Medical Solutions USA, Inc. | 2026-03-20 |
| AutoContour (RADAC V5) (K260509) | Radformation, Inc. | 2026-03-19 |
| syngo.via RT Image Suite VC10 (K252304) | Varian Medical Systems, Inc. | 2026-03-18 |
| AlignRT Plus (8.0) (K253012) | Vision Rt, Ltd. | 2026-03-18 |
| EchoNavigator R5.0 (K253614) | Philips Medical Systems Nederland B.V. | 2026-03-17 |
| Data Analysis Facilitation Suite (DAFS) (K253944) | Voronoi Health Analytics Incorporated | 2026-03-16 |
| Sonio Detect (v3) (K252433) | Sonio | 2026-03-16 |
| Aeka Imaging (K253111) | Good Methods Global, Inc. | 2026-03-13 |
| Embrace Neonatal MRI System (K254277) | Aspect Imaging, Ltd. | 2026-03-13 |
| TheraSphere 360™ Y-90 Management Platform (K260479) | Boston Scientific Corporation | 2026-03-13 |
| Aquilion ServeSP (TSX-307B) V2.0 (K260078) | Canon Medical Systems Corporation | 2026-03-13 |
| Extremity CT Imaging System (K252249) | Mars Bioimaging , Ltd. | 2026-03-13 |
| InferCare RECIST (K252261) | Beijing Infervision Healthcare Medical Technology Co., Ltd. | 2026-03-13 |
| Mimics Thoracic Planner (K251964) | Materialise NV | 2026-03-12 |
| Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System (K253185) | Carestream Health | 2026-03-11 |
| Sonosite iLOOK Ultrasound System (K260595) | FUJIFILM Sonosite, Inc. | 2026-03-10 |
| myray ProXIma X6 (K252353) | Cefla S.C. | 2026-03-10 |
| Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension) (K253584) | Canon Medical Systems Corporation | 2026-03-10 |
| LiverMultiScan (v6.0) (K253413) | Perspectum, Ltd. | 2026-03-09 |
| VELYS™ Hip Navigation (K253551) | Depuy Ireland UC | 2026-03-06 |
| Bunkerhill Contrast CAC (K260166) | BunkerHill Health | 2026-03-06 |
| Bunkerhill Contrast AVC (K260167) | BunkerHill Health | 2026-03-06 |
| CEPHX3D (K252538) | Orca Dental AI , Ltd. | 2026-03-05 |
| AV Cardiac CT (K260169) | Philips Medical Systems Nederland B.V. | 2026-03-05 |
| Magnifico Open (100009900) (K251901) | Esaote, S.p.A. | 2026-03-05 |
| QT Scanner 2000 Model A (K253898) | QT Imaging Holdings, Inc. | 2026-03-04 |
| Annalise Enterprise (K253818) | Harrison-AI Medical Pty, Ltd. | 2026-03-03 |
| Clarius Ejection Fraction AI (K253593) | Clarius Mobile Health Corp. | 2026-03-02 |
| Ligence Heart (K253535) | Ligence Uab | 2026-02-27 |
| BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device (K253578) | Aidoc Medical , Ltd. | 2026-02-26 |
| AI Platform 2.2 (AIP002) (K260217) | Exo Imaging | 2026-02-24 |
| IntraSight Plus (K253714) | Philips Image Guided Therapy Corporation | 2026-02-24 |
| MAGNETOM Flow.Ace; MAGNETOM Flow.Plus (K260265) | Siemens Shenzhen Magnetic Resonance , Ltd. | 2026-02-23 |
| Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including Upgrades (K253648) | Philips Medical Systems Nederland B.V. | 2026-02-23 |
| SKIA-Head (Model: SKIA-ST00) (K253486) | Skia, Inc. | 2026-02-23 |
| AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini) (K253244) | Poskom Co., Ltd. | 2026-02-23 |
| CARA System (K252500) | Cara Medical, Ltd. | 2026-02-20 |
| AS Software Version Asera (K260205) | AS Software, LLC | 2026-02-19 |
| TrueFit Bolus (K260308) | Adaptiiv Medical Technologies, Inc. | 2026-02-19 |
| Monaco RTP System (6.3) (K252002) | Elekta Solutions AB | 2026-02-19 |
| uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES) (K253564) | Shanghai United Imaging Healthcare Co., Ltd. | 2026-02-13 |
| Delivery Date AI (DEN250007) | Ultrasound AI | 2026-02-11 |
| AI4CMR v2.0 (K252084) | Ai4medimaging Medical Solutions S.A. | 2026-02-11 |
| 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 (K253049) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2026-02-11 |
| ArmSure Fluoroscopic Positioning System (K251992) | Savfe Co. , Ltd. | 2026-02-11 |
| 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 (K252179) | Shenzhen RF Tech Co., Ltd. | 2026-02-10 |
| SpaceOAR Vue System (SV-2101) (K260119) | Boston Scientific Corporation | 2026-02-10 |
| MI View&GO (K254016) | Siemens Medical Solutions USA, Inc. | 2026-02-10 |
| LAIA XR (K251577) | Augmented Reality Software S.L. | 2026-02-06 |
| LiveMedica Enterprise PACS (K253927) | Live Medica, LLC | 2026-02-06 |
| Median LCS (internal name) / eyonis LCS (trade name) (1.0) (K251474) | Median Technologies | 2026-02-06 |
| SIGNA™ Bolt (K253780) | Ge Medical Systems, LLC | 2026-02-06 |
| Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro) (K253221) | Eieling Technology (Shenzhen) Limited | 2026-02-06 |
| SIGNA™ Sprint Select (K253779) | Ge Medical Systems, LLC | 2026-02-05 |
| Primevision 3D (K253959) | Dentsply Sirona | 2026-02-05 |
| TAP2D (K252649) | Nano-X Imaging , Ltd. | 2026-02-02 |
| RevealAI-Lung (K251769) | Precision Medical Ventures, Inc. Dba Revealdx | 2026-01-30 |
| Neurophet AQUA AD Plus (K252496) | Neurophet., Inc. | 2026-01-29 |
| Surgical Reality Viewer (K252091) | Medicalvr B.V. | 2026-01-29 |
| Seg Pro V3 (RT-300) (K251306) | Ever Fortune.Ai, Co., Ltd. | 2026-01-28 |
| BriefCase-Triage (K251195) | Aidoc Medical , Ltd. | 2026-01-27 |
| Ascent3T Neonatal Magnetic Resonance Imaging System (K253499) | Eyas Medical Imaging, Inc. | 2026-01-26 |
| AccuContour 4.0 (K251351) | Manteia Technologies Co., Ltd. | 2026-01-23 |
| 3.0T AIR 32CH HNA (K253738) | Ge Healthcare Coils (Usa Instruments, Inc.) | 2026-01-23 |
| AV Vascular (K253735) | Philips Medical Systems Nederland B.V. | 2026-01-22 |
| AI-Rad Companion Brain MR (K253057) | Siemens Healthcare GmbH | 2026-01-22 |
| Halcyon, Ethos Radiotherapy System (5.0) (K252977) | Varian Medical Systems, Inc. | 2026-01-21 |
| Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System (K253597) | Canon Medical Systems Corporation | 2026-01-20 |
| DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector (K250954) | Carestream Health | 2026-01-20 |
| uCT 780 with uWS-CT-Dual Energy Analysis (K253173) | Shanghai United Imaging Healthcare Co., Ltd. | 2026-01-20 |
| Azurion R3.1 (K254186) | Philips Medical Systems B.V. | 2026-01-16 |
| Imagine® Enterprise Suite (K252634) | Softlink International Private Limited | 2026-01-16 |
| qXR-Detect (K251934) | Qure.Ai Technologies | 2026-01-16 |
| Diagnocat (K252934) | DGNCT, LLC | 2026-01-15 |
| BIOGRAPH One (K253023) | Siemens Healthineers AG | 2026-01-15 |
| EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy) (K252188) | Elekta Solutions AB | 2026-01-15 |
| dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS HeadNeck 3.0T (K254190) | Philips Medical Systems Nederland B.V. | 2026-01-14 |
| Orthoscan TAU MVP Mini C-Arm System (K252579) | Ziehm-Orthoscan, Inc. | 2026-01-14 |
| ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface (K254010) | Brainlab SE | 2026-01-14 |
| VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464) (K254001) | Spectrum Dynamics Medical, Ltd. | 2026-01-13 |
| LOGIQ Totus (K253370) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2026-01-08 |
| View (K253639) | GE Healthcare | 2026-01-08 |
| 3DICOM MD Cloud (K253784) | Singular Health Pty, Ltd. | 2026-01-08 |
| BriefCase-Triage: CARE Multi-triage CT Body (K252970) | Aidoc Medical , Ltd. | 2026-01-07 |