| LOGIQ Fortis (K253366) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2026-01-07 |
| DS Core Detect (K253009) | Dentsply Sirona, Inc. | 2026-01-07 |
| ChartCheck (RADCH V1.6) (K252988) | Radformation, Inc. | 2026-01-05 |
| 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 (K252018) | Samsung Medison Co., Ltd. | 2026-01-05 |
| maiLink (K253008) | Maihub Corp. | 2026-01-05 |
| TruSPECT Processing Station (K253532) | Spectrum Dynamics Medical, Ltd. | 2025-12-30 |
| AnyScan 3.0 NM Scanner Family (K253844) | Mediso Medical Imaging Systems, Ltd. | 2025-12-30 |
| AIR Recon DL (K252379) | Ge Medical Systems, LLC | 2025-12-23 |
| ART-Plan+ (v3.1.0) (K253091) | Therapanacea Sas | 2025-12-23 |
| Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP) (K251268) | Edan Instruments, Inc. | 2025-12-23 |
| Sim&Size (K253122) | Sim&Cure | 2025-12-23 |
| MC2 Portable X-ray System (K252068) | Oxos Medical | 2025-12-22 |
| Lumify Diagnostic Ultrasound System (K252557) | Philips Ultrasound, LLC | 2025-12-22 |
| PeekMed web (K252856) | Peek Health, S.A. | 2025-12-22 |
| BioticsAI (K250959) | Bioticsai, Inc. | 2025-12-22 |
| RayStation (2024A SP3) (K252109) | RaySearch Laboratories AB (PUBL) | 2025-12-22 |
| Airbile-100 (K250976) | Poskom Co., Ltd. | 2025-12-19 |
| AI-CVD (K252029) | HeartLung Corporation | 2025-12-19 |
| Rectal Applicator (K251037) | Nucletron B.V. | 2025-12-19 |
| LCD Monitor (CL1902A, CL2103F) (K252780) | Shenzhen Beacon Display Technology Co., Ltd. | 2025-12-19 |
| Alzevita (K252670) | TOPIA MEDTECH LIMITED | 2025-12-19 |
| ClearCalc Model RADCA V2.6 (K252863) | Radformation, Inc. | 2025-12-19 |
| LIA Console (542-7) (K251730) | Leadoptik, Inc. | 2025-12-19 |
| 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 (K252838) | Siemens Healthcare GmbH | 2025-12-19 |
| RefleXion Medical Radiotherapy System, Reflexion X2 (K252071) | Reflexion Medical, Inc. | 2025-12-18 |
| MediAI-BA (K250914) | Crescom Co., Ltd. | 2025-12-18 |
| PVAD IQ Software (K252235) | Ultrasight , Ltd. | 2025-12-18 |
| UltraSight Guidance (K251416) | Ultrasight , Ltd. | 2025-12-17 |
| Neosoma Brain Mets (K252922) | Neosoma, Inc. | 2025-12-17 |
| SKAN C PULSAR (K251893) | Skanray Technologies Limited | 2025-12-16 |
| IRISeg (K251763) | Intuitive Surgical, Inc. | 2025-12-16 |
| IDENTIFY (5.0) (K252919) | Varian Medical Systems, Inc. | 2025-12-16 |
| HyperVue™ Imaging System - Integrated (K253101) | Spectrawave, Inc. | 2025-12-15 |
| Swoop® Portable MR Imaging® System (K253489) | Hyperfine, Inc. | 2025-12-12 |
| CogNet AI-MT+ (K252482) | Medcognetics, Inc. | 2025-12-11 |
| MIM – LesionID Pro (K251883) | Mim Software, Inc. | 2025-12-11 |
| Allia Moveo (K251199) | GE Medical Systems SCS | 2025-12-09 |
| Fetal EchoScan (v1.2) (K252294) | Brightheart | 2025-12-08 |
| Overjet CBCT Assist (K251514) | Overjet, Inc. | 2025-12-05 |
| Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11 Super/X11 Senior/X11/E11/E11 Pro/E11 Plus/E11 Elite/X11T/X11U/X11R/X11i/X11s/E11T/E11i/E11s/XR1/XR2/ XR3/ER1/ER2/ER3/X10 Exp/X10 Elite/X10 Pro/X10 Plus/X10 Super/X10 Senior/X10/X10T/X10U/ X10R/X10i/X10s/E10/E10 Pro/E10 Plus/E10T/E10i/E10s/SU11A EXP/SU11A PRO/SU11A AD/ SU11A CU/SU11B EXP/SU11B PRO/SU11B AD/SU11B CU/SU11C EXP/SU11C PRO/SU11C AD/ SU11C CU) (K252498) | Sonoscape Medical Corp. | 2025-12-05 |
| ARTAssistant (K250780) | Manteia Technologies Co., Ltd. | 2025-12-05 |
| OncoPatch (K252296) | Oncopatch, Inc. | 2025-12-05 |
| ASUS Ultrasound Imaging System (LU800 series) (K250791) | Asustek Computer, Inc. | 2025-12-04 |
| GentleBeam (GB1000) (K250692) | Voxel Ray Solutions, LLC | 2025-12-03 |
| Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous 6/Fibrous 5 Diagnostic UltrasoundSystem (K251601) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025-12-03 |
| AVIEW Lung Nodule CAD (K251203) | Coreline Soft Co., Ltd. | 2025-12-03 |
| Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) (K252103) | Mighty Oak Medical | 2025-12-02 |
| Cartesion Prime (PCD-1000A/3) V10.21 (K251370) | Canon Medical Systems Corporation | 2025-12-01 |
| CT VScore+ (K252217) | Canon Medical Informatics, Inc. | 2025-11-28 |
| uDR Arria & uDR Aris (K252000) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-11-26 |
| OEC One CFD (K253269) | Ge Hualun Medical Systems Co. , Ltd. | 2025-11-26 |
| 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30) (K253310) | Esaote, S.p.A. | 2025-11-25 |
| Scaida BrainCT-ICH (v1.0) (K250694) | Mlhealth 360 | 2025-11-25 |
| PennPET Explorer Positron Emission Tomograph (K251401) | Trustees of the University of Pennsylvania | 2025-11-25 |
| RCT700 (K251798) | Ray Co., Ltd. | 2025-11-25 |
| a2z-Unified-Triage (K252366) | A2z Radiology Ai, Inc. | 2025-11-24 |
| Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 (K252328) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2025-11-24 |
| Archy Dental Imaging (K251880) | Archy Dental, Inc. | 2025-11-21 |
| MAGNETOM Free.Max; MAGNETOM Free.Star (K251822) | Siemens Shenzhen Magnetic Resonance , Ltd. | 2025-11-20 |
| PlanOne 1 (K250963) | Cosylab Jsc, Control System Laboratory | 2025-11-20 |
| syngo.MR Applications (VB80) (K253495) | Siemens Healthineers AG | 2025-11-20 |
| Guided Aarhus Applicator Set (K252884) | Varian Medical Systems | 2025-11-19 |
| ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound System (K253487) | Siemens Medical Solutions USA, Inc. | 2025-11-17 |
| DTX Studio Assist (K252086) | Nobel Biocare C/O Medicim NV | 2025-11-17 |
| AutoDensity (K251078) | Eos Imaging | 2025-11-14 |
| Second Opinion® Panoramic (K250525) | Pearl, Inc. | 2025-11-14 |
| Dental Computed Tomography X-ray System (K251842) | Fussen Technology Co., Ltd. | 2025-11-13 |
| ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound System (K253457) | Siemens Medical Solutions USA, Inc. | 2025-11-13 |
| PeekMed web (K252452) | Peek Health, S.A. | 2025-11-12 |
| Fibresolve (with PCCP) (K252041) | Imvaria, Inc. | 2025-11-07 |
| SugarBug (1.x) (K250264) | Bench7, Inc. | 2025-11-07 |
| Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S, Consona EI, Consona EF, Consona N5 Elite, Consona N5 Ultra, Consona N3, Consona N3 Exp Diagnostic Ultrasound System (K251853) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025-11-07 |
| BriefCase-Triage (K253265) | Aidoc Medical , Ltd. | 2025-11-06 |
| Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M) (K251004) | Hefei Chimed Intelligent Machine Co., Ltd. | 2025-11-06 |
| Adaptix Ortho350 (K252133) | Adaptix Limited | 2025-11-06 |
| Cios Select (K250241) | Siemens Medical Solutions USA, Inc. | 2025-11-04 |
| VXvue (K251410) | Vieworks Co., Ltd. | 2025-11-04 |
| Sonosite MT Ultrasound System (K253448) | FUJIFILM Sonosite, Inc. | 2025-11-03 |
| ZAP-X Radiosurgery System (ZAP-X) (K250392) | Zap Surgical Systems, Inc. | 2025-11-03 |
| 3mensio Workstation (K250330) | Pie Medical Imaging BV | 2025-11-03 |
| Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) (K251532) | Mighty Oak Medical | 2025-11-03 |
| Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System (K252074) | Canon Medical Systems Corporation | 2025-10-31 |
| Pulsenmore ES (DEN240074) | Pulsenmore, Ltd. | 2025-10-31 |
| AiORTA - Plan (K250337) | ViTAA Medical Solutions, Inc. | 2025-10-30 |
| LOGIQ E10s (K251963) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2025-10-29 |
| LCD Monitor (C1216W, C822W, C821W) (K253242) | Shenzhen Beacon Display Technology Co., Ltd. | 2025-10-29 |
| LOGIQ E10 (K251985) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2025-10-29 |
| TheraSphere 360™ Y-90 Management Platform (K252547) | Boston Scientific Corporation | 2025-10-28 |
| cvi42 Coronary Plaque Software Application (K251027) | Circle Cardiovascular Imaging, Inc. | 2025-10-27 |
| AccuCheck (K250696) | Manteia Technologies Co., Ltd. | 2025-10-24 |
| Mobile X-ray unit (!M1) (K251710) | Solutions For Tomorrow AB | 2025-10-24 |
| Syngo Carbon Clinicals (VA41) (K251059) | Siemens Healthineers AG | 2025-10-24 |
| Azurion R3.1 (K251827) | Philips Medical Systems B.V. | 2025-10-24 |
| TeraRecon Cardiovascular.Calcification.CT (K250288) | Terarecon,Inc. | 2025-10-23 |
| ANDI 2.0 (K252298) | Imeka Solutions, Inc. | 2025-10-22 |
| Sirona Advanced Imaging Suite (K251030) | Sirona Medical | 2025-10-22 |
| brAIn™ Shoulder Positioning (K252665) | Avatar Medical | 2025-10-20 |
| InkSpace Imaging Small Body Array (SBA12PH30x) (K253182) | Inkspace Imaging, Inc. | 2025-10-20 |
| MOSkin Radiation Measurement System (K250911) | Electrogenics Labs, Ltd. | 2025-10-17 |
| X9 Ultrasound System (K251673) | X9, Inc. | 2025-10-17 |