| TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D) (K242015) | DRGEM Corporation | 2024-12-16 |
| ULTIMUS Series Ultrasound Diagnostic System (K240676) | Vinno Technology (Suzhou) Co.,Ltd | 2024-12-16 |
| Sim&Size (K242124) | Sim&Cure | 2024-12-14 |
| Laminar P1 (LDH-HW-001) (K242487) | Laminar Digital Health, Inc. | 2024-12-13 |
| ARIA Radiation Therapy Management System (18.1) (K242463) | Varian Medical Systems, Inc. | 2024-12-13 |
| EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System (K242020) | Philips Ultrasound, LLC | 2024-12-12 |
| uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) (K243538) | Shanghai United Imaging Healthcare Co., Ltd. | 2024-12-12 |
| Eclipse Treatment Planning System (18.1) (K242378) | Varian Medical Systems | 2024-12-11 |
| BriefCase-Triage (K243548) | Aidoc Medical , Ltd. | 2024-12-11 |
| DRX-Revolution Mobile X-ray System (K241505) | Carestream Health, Inc. | 2024-12-10 |
| Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler Ultrasound Imaging System (Readius P8); Digital Color Doppler Ultrasound Imaging System (Readius V6); Digital Color Doppler Ultrasound Imaging System (Readius C6) (K243132) | Shantou Institute of Ultrasonic Instruments Co., Ltd. | 2024-12-10 |
| IRISeg (K242461) | Intuitive Surgical, Inc. | 2024-12-10 |
| V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic Ultrasound System, XH5 Diagnostic Ultrasound System, V4 Diagnostic Ultrasound System, H4 Diagnostic Ultrasound System, XV4 Diagnostic Ultrasound System, XH4 Diagnostic Ultrasound System (K242511) | Samsung Medison Co., Ltd. | 2024-12-10 |
| AutoContour (Model RADAC V4) (K242729) | Radformation, Inc. | 2024-12-09 |
| Digital Radiography System (ManntiX B, ManntiX K) (K240841) | Shenzhen Browiner Tech Co., Ltd. | 2024-12-09 |
| MC2 Portable X-ray System (K241567) | Oxos Medical | 2024-12-06 |
| Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert (K241989) | Cercare Medical A/S | 2024-12-06 |
| EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100) (K241923) | Ever Fortune.Ai, Co., Ltd. | 2024-12-06 |
| CDM Insights (K240680) | Oxford Brain Diagnostics, Ltd. | 2024-12-06 |
| SyMRI (K242524) | Syntheticmr AB (Publ.) | 2024-12-06 |
| PeekMed web (K240926) | Peek Health, S.A. | 2024-12-06 |
| DrAid™ for Liver Segmentation (K241543) | Vinbrain Joint Stock Company | 2024-12-06 |
| Rapid Surgical Plan (RSP-SW-001) (K243447) | Navbit Pty, Ltd. | 2024-12-05 |
| XBeam (v2) (K240671) | Xstrahl, Ltd. | 2024-12-04 |
| Nanox.ARC (K242395) | Nano-X Imaging , Ltd. | 2024-12-04 |
| ClearRead CT CAC (K242188) | Riverain Technologies, Inc. | 2024-12-03 |
| Sonix Health (K240645) | Ontact Health Co., Ltd. | 2024-11-27 |
| RadiForce RX570; RadiForce RX570-AR (K243221) | Eizo Corporation | 2024-11-27 |
| HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System (K242444) | Samsung Medison Co., Ltd. | 2024-11-27 |
| Intraluminal Applicator Set (K242961) | Varian Medical Systems | 2024-11-26 |
| RadUnity (Version 1.0.0) (K242810) | Radunity Corp. | 2024-11-26 |
| MROpen Evo (03-2000-00); MROpen Evo (03-4000-00) (K242258) | Asg Superconductors S.P.A. | 2024-11-26 |
| Transpara (2.1.0) (K241831) | Screenpoint Medical B.V. | 2024-11-25 |
| BriefCase-Quantification (K242203) | Aidoc Medical , Ltd. | 2024-11-22 |
| Jazz Classic (K241495) | Jazz Imaging | 2024-11-21 |
| Gating Reflector Block (K242874) | Varian Medical Systems, Inc. | 2024-11-21 |
| SKR 3000 (K241319) | Konica Minolta, Inc. | 2024-11-21 |
| Strain AI (SAI001) (K242359) | Exo, Inc. | 2024-11-20 |
| “BRAXX” Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002) (K243045) | Braxx Biotech Co., Ltd. | 2024-11-19 |
| XENOVIEW 3.0T Chest Coil (K243316) | Polarean, Inc. | 2024-11-19 |
| Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C) (K242496) | Eieling Technology (Shenzhen) Limited | 2024-11-19 |
| ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound System (K242523) | Siemens Medical Solutions USA, Inc. | 2024-11-19 |
| CT Collaboration Live (K242329) | Philips Healthcare (Suzhou) Co., Ltd. | 2024-11-18 |
| Saige-Dx (K241747) | DeepHealth, Inc. | 2024-11-18 |
| Koios DS (K242130) | Koios Medical, Inc. | 2024-11-15 |
| ACUSON Redwood Diagnostic Ultrasound System (K243299) | Siemens Medical Solutions USA, Inc. | 2024-11-15 |
| 1CMR Pro (K242062) | Mycardium AI Limited | 2024-11-15 |
| VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage (K241439) | Vuno, Inc. | 2024-11-15 |
| The 5000 Compact Series Ultrasound Systems (K242800) | Philips Ultrasound, LLC | 2024-11-15 |
| VIVIX-S 1751S (K241125) | Vieworks Co., Ltd. | 2024-11-15 |
| Fetal EchoScan (K242342) | Brightheart | 2024-11-14 |
| PRORAD X-Ray Flat Panel Detector with DROC (K240771) | Prognosys Medical Systems Private Limited | 2024-11-12 |
| Change Healthcare Stratus Imaging PACS (K241981) | Change Healthcare Canada Company | 2024-11-12 |
| Hybrid Viewer (00859873006189) (K241364) | Hermes Medical Solutions AB | 2024-11-08 |
| ProFound Detection (V4.0) (K240417) | Icad, Inc. | 2024-11-08 |
| 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 (K242231) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2024-11-08 |
| IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector) (K241346) | Aspen Imaging Healthcare, Inc. | 2024-11-07 |
| NeuroICH (K241719) | Neurocareai, Inc. | 2024-11-07 |
| Titanium Fletcher-Style Applicator Set Defined Geometry; Smit Cervical Sleeve (K241853) | Varian Medical Systems, Inc. | 2024-11-07 |
| icobrain aria (K240712) | Icometrix NV | 2024-11-07 |
| TeraRecon Cardiac.Chambers.MR (1.0.0) (K241312) | Terarecon,Inc. | 2024-11-05 |
| JLK-PWI (K242709) | JLK, Inc. | 2024-11-04 |
| uDR 780i (K241068) | Shanghai United Imaging Healthcare Co., Ltd. | 2024-11-01 |
| eRAD PACS (K241223) | Erad, Inc. | 2024-10-31 |
| Symbia Pro.specta Q3 (11364751); Symbia Pro.specta X3 (11364752); Symbia Pro.specta X7 (11364753); Symbia Pro.specta VA30A Family (K243186) | Siemens Medical Solutions USA, Inc. | 2024-10-30 |
| RemedyLogic AI MRI Lumbar Spine Reader (K241108) | Remedy Logic, Inc. | 2024-10-30 |
| Catheter Surface Flap Applicator Set (GM11011830) (K241965) | Varian Medical Systems | 2024-10-29 |
| LCD Monitors C310S, G310S, C316S, G316S, C616W (K243031) | Shenzhen Beacon Display Technology Co., Ltd. | 2024-10-25 |
| Neurophet AQUA (V3.1) (K242215) | Neurophet., Inc. | 2024-10-25 |
| TumorSight Viz (K243189) | SimBioSys, Inc. | 2024-10-25 |
| ROCC Console (K242512) | Philips Medical Systems Nederland B.V. | 2024-10-24 |
| Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L) (K241554) | Telefield Medical Imaging (Shenzhen) Limited | 2024-10-24 |
| EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DEXi-D503T-FRM); EXSYS DEXi (EXSYS DEXi-A503T-FRM); EXSYS DEXi (EXSYS DEXi-D401S-FRA); EXSYS DEXi (EXSYS DEXi-D402S-FRA); EXSYS DEXi (EXSYS DEXi-D401P-FRA); EXSYS DEXi (EXSYS DEXi-D402P-FRA); (K242847) | DRTECH Corporation | 2024-10-23 |
| MIM – Symphony HDR Fusion (K243012) | Mim Software, Inc. | 2024-10-23 |
| Vitesse (5.0) (K241876) | Varian Medical Systems | 2024-10-23 |
| TrueFit Bolus; TrueFlex Bolus (K243057) | Adaptiiv Medical Technologies, Inc. | 2024-10-23 |
| ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A) (ceiling); ARTIS pheno (VE40A) (K241572) | Siemens Medical Solutions USA, Inc. | 2024-10-22 |
| nordicMEDiVA (K243209) | Nordicneurolab AS | 2024-10-22 |
| Spectral CT 7500 RT (K240844) | Philips Medical Systems Technologies , Ltd. | 2024-10-18 |
| dS Wrist coil 8ch 1.5T (K243033) | Philips Medical Systems Nederland B.V. | 2024-10-18 |
| BriefCase-Triage (K242837) | Aidoc Medical , Ltd. | 2024-10-18 |
| Contour+ (MVision AI Segmentation) (K241490) | Mvision AI OY | 2024-10-18 |
| dS Knee Coil 8ch 1.5T (K242879) | Philips Medical Systems Nederland B.V. | 2024-10-18 |
| SIGNA MAGNUS (K241242) | Ge Medical Systems, LLC | 2024-10-17 |
| JLK-CTP (K242556) | JLK, Inc. | 2024-10-16 |
| VINT (K240385) | Mediimg Corporation | 2024-10-15 |
| cvi42 Software Application (K242781) | Circle Cardiovascular Imaging, Inc. | 2024-10-15 |
| syngo Application Software (K241569) | Siemens Medical Solutions USA, Inc. | 2024-10-11 |
| HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound System (K241971) | Samsung Medison Co., Ltd. | 2024-10-11 |
| uDR 380i Pro (K242515) | Shanghai United Imaging Healthcare Co., Ltd. | 2024-10-10 |
| EchoMeasure (K241430) | Icardio.Ai | 2024-10-10 |
| AutoChamber (K240786) | HeartLung Corporation | 2024-10-10 |
| Limbus Contour (K241837) | Limbus Ai, Inc. | 2024-10-09 |
| EPIQ Series Diagnostic Ultrasound System (K240980) | Philips Ultrasound, LLC | 2024-10-07 |
| SpineUs™ System (K241029) | Verdure Imaging | 2024-10-07 |
| EchoSolv AS (K241245) | Echo IQ, Ltd. | 2024-10-04 |
| LVivo Software Application (K240553) | Dia Imaging Analysis, Ltd. | 2024-10-04 |
| Lunit INSIGHT DBT v1.1 (K242652) | Lunit, Inc. | 2024-10-04 |
| VitruvianScan (v1.0) (K241925) | Perspectum, Ltd. | 2024-10-02 |
| MammoScreen BD (K241561) | Therapixel | 2024-10-02 |