| DEEPVESSEL Plaque (K260497) | Keya Medical Technology Co., Ltd. | 2026-06-04 |
| HeartFocus (K260780) | Deski | 2026-06-03 |
| CustoMED Viewer (K260116) | CustoMED , Ltd. | 2026-06-03 |
| HistoSonics® Planning Tool (K252947) | HistoSonics, Inc. | 2026-05-29 |
| OrthoGrid Hip AI® 4.0 (K260077) | OrthoGrid Systems, Inc. | 2026-05-29 |
| Nexus DRF Digital X-ray Imaging System (K253103) | Varex Imaging Corporation | 2026-05-29 |
| 780 nm SPY Portable Handheld Imaging (SPY-PHI) System (K261037) | Stryker Endoscopy | 2026-05-28 |
| ANDI 2.2 (K261405) | Imeka Solutions, Inc. | 2026-05-28 |
| Bellalun 2D (VDMS-1000S) (K254092) | Vieworks Co., Ltd. | 2026-05-28 |
| Multimodality Simulation Workspace (MM Sim) (v1.0.0) (K260207) | Philips Medical Systems Nederland B.V. | 2026-05-27 |
| Synapse Lung Nodule AI (K254075) | Fujifilm Corporation | 2026-05-27 |
| EPIQ Series Diagnostic Ultrasound System (K260123) | Philips Ultrasound, LLC | 2026-05-27 |
| Helion Viewer Suite (K254265) | Videomed Srl ( a Baxter Healthcare Corp company) | 2026-05-27 |
| EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems (K260680) | Philips Ultrasound, LLC | 2026-05-27 |
| LOGIQ e (K260398) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2026-05-26 |
| Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning (K260324) | Canon Medical Informatics, Inc. | 2026-05-22 |
| eXaSkin Plus (K252784) | Anatomical Geometry S.L. | 2026-05-22 |
| C-beam (K252735) | Pulmera, Inc. | 2026-05-22 |
| uMR Astra (K260113) | Shanghai United Imaging Healthcare Co., Ltd. | 2026-05-22 |
| SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp, SonoPort 1 Pro, SonoPort 1 Elite, SonoPort 1 Plus, SonoPort 2, SonoPort 2 Exp, SonoPort 2 Pro, SonoPort 2 Elite, SonoPort 2 Plus, SonoPort 3, SonoPort 3 Exp, SonoPort 3 Pro, SonoPort 3 Elite, SonoPort 3 Plus, SonoPort 4, SonoPort 4 Exp, SonoPort 4 Pro, SonoPort 4 Elite, SonoPort 4 Plus, SonoPort 5, SonoPort 5 Exp, SonoPort 5 Pro, SonoPort 5 Elite, SonoPort 5 Plus, SonoPort 6, SonoPort 6 Exp, SonoPort 6 (K253949) | CHISON Medical Technologies Co., Ltd. | 2026-05-22 |
| BAC (K254131) | DeepHealth, Inc. | 2026-05-21 |
| Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 Family (K261315) | Siemens Medical Solutions USA, Inc. | 2026-05-21 |
| MSK Go (K260234) | Smart Alfa Teknoloji San. Ve Tic. A.S. | 2026-05-21 |
| uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace, uSONIQUE Grace Elite (K253720) | Wuhan United Imaging Healthcare Co.,Ltd | 2026-05-21 |
| Aquilion ONE (TSX-308A/TSX-306A) V2.0 (K253596) | Canon Medical Systems Corporation | 2026-05-20 |
| MAASTRO Rectal Applicator Set (K252717) | Varian Medical Systems | 2026-05-20 |
| CMN Capillary Function with Virtual Expert for MRI, CT and CBCT (K253831) | Cercare Medical A/S | 2026-05-18 |
| medXion NEXUS (K253935) | medXion Technologies, Inc. | 2026-05-15 |
| SubtleHD-CT (1.x) (K254120) | Subtle Medical, Inc. | 2026-05-15 |
| Neurophet SCALE PET (K252563) | Neurophet., Inc. | 2026-05-15 |
| uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE Genesis Super, uSONIQUE Pulse, uSONIQUE Pulse Pro, uSONIQUE Pulse Elite, uSONIQUE Pulse Super, uSONIQUE Venus, uSONIQUE Venus Pro, uSONIQUE Venus Elite, uSONIQUE Venus Super (K253716) | Wuhan United Imaging Healthcare Co.,Ltd | 2026-05-15 |
| Digital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra Senior, Autra CV, e-Autra, Autra 75, Autra 85W, Autra 65, Autra 55, Autra 65i, Autra 90 Elite, Autra 85 Elite, Autra 80 Elite, Autra 75 Elite, Autra 85 CV, Autra 80W, Autra 65 Elite, Autra 55 Elite, Autra 55i, Autra 90 CV, Autra 85, Autra 80, Autra 80 CV, Autra 75 Pro, Autra 75W, Autra 70 Elite, Autra 70, Autra T) (K254028) | Sonoscape Medical Corp. | 2026-05-15 |
| UNiD™ Spine Analyzer (SW3002) (K261289) | Medicrea International S.A.S. (Medtronic) | 2026-05-15 |
| Neurophet AQUA (K261273) | Neurophet., Inc. | 2026-05-15 |
| ART.1-US (K253078) | Seetreat Pty, Ltd. | 2026-05-14 |
| BriefCase-Triage (K261317) | Aidoc Medical , Ltd. | 2026-05-14 |
| Palmtop Ultrasound Diagnostic System (MT10P/MT10) (K260111) | Mytech Intelligence (Shenzhen) Co., Ltd. | 2026-05-14 |
| SubtleHD-PET (1.x) (K254013) | Subtle Medical, Inc. | 2026-05-14 |
| RAYMO Mobile X-ray System (Model: RAYMO) (K260085) | DRGEM Corporation | 2026-05-14 |
| SURGIMAGE SIM 1000H Fluorescence Imaging Platform (K253181) | Surgimage Corporation | 2026-05-13 |
| Morph (K260032) | BeauBrain Healthcare, Inc. | 2026-05-13 |
| Rayvolve (K260378) | AZmed | 2026-05-12 |
| Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic Ultrasound System (MU9T);Diagnostic Ultrasound System (MU9 Exp);Diagnostic Ultrasound System (MU9 Pro);Diagnostic Ultrasound System (MU9 Super);Diagnostic Ultrasound System (MU9P);Diagnostic Ultrasound System (MU9A);Diagnostic Ultrasound System (MU7);Diagnostic Ultrasound System (MU7S);Diagnostic Ultrasound System (MU7T);Diagnostic Ultrasound System (MU7 Exp);Diagnostic Ultrasound System (MU7 Pro);Diagnos (K260846) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2026-05-11 |
| Velmeni for Dentists (V4D) Endo-Perio (K252953) | Velmeni, Inc. | 2026-05-11 |
| HipGuide (V 1.0.0.0) (K260321) | Orthopedic Driven Imaging, LLC | 2026-05-08 |
| AerFrame Patient Immobilization System (AFPIS) (K260792) | Stabilix, LLC | 2026-05-08 |
| Healium Intelliscan LX192LC (K261132) | Healium Intelliscan Corporation | 2026-05-05 |
| Lumify Diagnostic Ultrasound System (K252558) | Philips Ultrasound, LLC | 2026-05-05 |
| MammoSightAI (K252954) | Neurocareai, Inc. (Dba Savelife.Ai) | 2026-05-04 |
| Neowise (K260716) | Cefla S.C. | 2026-05-04 |
| Synapse 3D Base Tools (V7.2) (K254189) | Fujifilm Corporation | 2026-04-30 |
| Intelligent NR (K252503) | Canon, Inc. | 2026-04-30 |
| syngo Application Software (K254184) | Siemens Medical Solutions USA, Inc. | 2026-04-29 |
| ES-Series (K260589) | E-Scopics | 2026-04-29 |
| DeepHealth ProstateAI (K253682) | Quantib B.V. | 2026-04-29 |
| EdgeFlow Gel Pad (K252337) | Edgecare, Inc. | 2026-04-24 |
| OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001) (K253459) | ABBOTT MEDICAL | 2026-04-24 |
| ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno (K254173) | Siemens Medical Solutions USA, Inc. | 2026-04-24 |
| LungPoint Virtual Bronchoscopic Navigation (VBN) Software (K260009) | Broncus Medical, Inc. | 2026-04-24 |
| CCI PACS VIEWER (PACS-US-001) (K254237) | CliniComp, Intl. | 2026-04-23 |
| Lunit INSIGHT MMG (v1.1.10) (K260320) | Lunit, Inc. | 2026-04-23 |
| 0.55T 12Ch Breast Coil (K260947) | Neocoil, LLC | 2026-04-23 |
| ARTIS genio floor; ARTIS icono.explore floor (K253752) | Siemens Medical Solutions USA, Inc. | 2026-04-23 |
| DS Core CBCT Anatomy (K260785) | Dentsply Sirona | 2026-04-23 |
| ProBeam 360 Proton Therapy System v3.0 (K252815) | Varian Medical Systems, Inc. | 2026-04-23 |
| uOmnispace.MR (K253077) | Shanghai United Imaging Healthcare Co., Ltd. | 2026-04-22 |
| EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100) (K253163) | Ever Fortune.Ai, Co., Ltd. | 2026-04-22 |
| Folliscan (K252332) | Mim Fertility | 2026-04-20 |
| Lunar Astra (K252718) | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2026-04-20 |
| EdgeFlow UW20 (K252237) | Edgecare, Inc. | 2026-04-17 |
| VERIQA RT EPID 3D (K252258) | Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla | 2026-04-15 |
| HD 8Ch Wrist Array (K252587) | Shenzhen RF Tech Co., Ltd. | 2026-04-14 |
| Critical Care Suite with Enteric Tube Positioning AI Algorithm (K253502) | Ge Medical Systems, LLC | 2026-04-14 |
| AI-Rad Companion Organs RT (K252548) | Siemens Healthcare GmbH | 2026-04-10 |
| Relu Cloud (K252708) | Relu BV | 2026-04-10 |
| Overjet Iris Intelligent Imaging System (K253930) | Overjet, Inc. | 2026-04-10 |
| AeroDR TX c02 (K253446) | Dk Medical Systems Co., Ltd. | 2026-04-10 |
| DeepBT Detector-Plus (K252190) | Aitewan Biomedical Technology, Inc. | 2026-04-10 |
| syngo Dynamics (VA41F) (K253689) | Siemens Healthcare GmbH | 2026-04-10 |
| Accuro XV (K254021) | Rivanna Medical, Inc. | 2026-04-09 |
| RCT800 (K260462) | Ray Co., Ltd. | 2026-04-09 |
| APERTO Lucent MRI System (K253862) | Fujifilm Corporation | 2026-04-06 |
| Ricoh 3D for Healthcare Bolus (K253025) | Ricoh 3D For Healthcare, LLC | 2026-04-06 |
| 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) (K253288) | Esaote, S.p.A. | 2026-04-06 |
| uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES) (K260524) | Shanghai United Imaging Healthcare Co., Ltd. | 2026-04-03 |
| ClearCheck (RADCC V2.7) (K253962) | Radformation, Inc. | 2026-04-03 |
| Wireless Probe Type Ultrasound Scanner (K252709) | Xuzhou Yongkang Electronic Science Technology Co., Ltd. | 2026-04-02 |
| BELLIGER ACE (K252229) | Genoray Co., Ltd. | 2026-04-02 |
| CoLumbo C-Spine (K254015) | Smart Soft Healthcare AD | 2026-04-01 |
| Medical Imaging Calibration Feature (MICF) (K253582) | Apple, Inc. | 2026-04-01 |
| 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 (K252876) | Shenzhen RF Tech Co., Ltd. | 2026-04-01 |
| Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS) (K260093) | VATECH Co., Ltd. | 2026-03-31 |
| RW-1 (K253029) | Mediott, Inc. | 2026-03-31 |
| AiORTA - Plan v2.0 (K254207) | ViTAA Medical Solutions, Inc. | 2026-03-30 |
| Avatar Medical Vision (K253950) | Avatar Medical | 2026-03-30 |
| Spectral CT Verida Family (K253649) | Philips Medical Systems Technologies , Ltd. | 2026-03-27 |
| Automated Aortic Stenosis Software (AutoAS) (K254161) | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2026-03-27 |
| S-scan Open (100001800) (K260746) | Esaote, S.p.A. | 2026-03-27 |
| EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System (K253595) | Philips Ultrasound, LLC | 2026-03-27 |
| Contour ProtégéAI+ (K253270) | Mim Software, Inc. | 2026-03-27 |