| uMC 560i (K183144) | Shanghai United Imaging Healthcare Co., Ltd. | 2019-12-19 |
| ZS3 and z.one pro Ultrasound Systems (K192410) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2019-12-19 |
| DentiqAir (K183676) | 3D Industrial Imaging Co., Ltd. | 2019-12-19 |
| syngo.CT CaScoring (K192763) | Siemens Medical Solutions USA, Inc. | 2019-12-17 |
| CareView 1800Le (K193173) | Careray Digital Medical System Co., Ltd. | 2019-12-13 |
| DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic Ultrasound System (K192152) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2019-12-13 |
| decimal3D (K192554) | .Decimal, LLC | 2019-12-13 |
| Deep Learning Image Reconstruction (K193170) | Ge Healthcare Japan Corporation | 2019-12-13 |
| QyScore Software (K192531) | Qynapse | 2019-12-13 |
| CoreLite X-Ray Specimen Cabinet (K193317) | Cirdan Imaging Limited | 2019-12-13 |
| Icobrain (K192130) | Icometrix NV | 2019-12-13 |
| HS50/HS60 Diagnostics Ultrasound System (K192505) | Samsung Medison Co., Ltd. | 2019-12-12 |
| NemoScan (K192571) | Software Nemotec S.L. | 2019-12-11 |
| Transpara (K192287) | Screenpoint Medical B.V. | 2019-12-10 |
| HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound System (K192319) | Samsung Medison Co., Ltd. | 2019-12-10 |
| PhantomMSK Trauma (K192279) | OrthoGrid Systems, Inc. | 2019-12-07 |
| 21HK512D (K191864) | Lg Electronics.Inc | 2019-12-05 |
| TOMi Scope (K191804) | Photonicare, Inc. | 2019-12-05 |
| Elekta Unity (K192482) | Elekta Limited | 2019-12-05 |
| SICAT Implant V2.0 (K192348) | Sicat GmbH & Co. KG | 2019-12-04 |
| Emprint Visualization Application (K192038) | Covidien, LLC | 2019-12-02 |
| EOSedge (K192079) | Eos Imaging | 2019-11-27 |
| fMRI Hardware System (K191032) | Nordicneurolab AS | 2019-11-27 |
| Diagnostic Ultrasound System (K192791) | Edan Instruments, Inc. | 2019-11-27 |
| HealthCXR (K192320) | Zebra Medical Vision, Ltd. | 2019-11-26 |
| 6450 Ultrasound system (K192157) | Esaote, S.p.A. | 2019-11-22 |
| EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP (K193017) | DRTECH Corporation | 2019-11-22 |
| Synergy Platform, Synergy, Infinity, VersaHD (K192242) | Elekta Limited | 2019-11-22 |
| Medsynapse Ris Pacs & Medsynapse VNA (K192508) | Medsynaptic Private, Ltd. | 2019-11-22 |
| EXPD 4343P, EXPD 3643P (K193031) | DRTECH Corporation | 2019-11-22 |
| SOMATOM Go Platform – SOMATOM go.Now, go.Up, go.All, go.Top, go.Sim, go.Open Pro, Scan & GO (K192061) | Siemens Medical Solutions USA, Inc. | 2019-11-21 |
| Ziehm 8000 (K190497) | Ziehm Imaging GmbH | 2019-11-20 |
| uPMR 790 (K192672) | Shanghai United Imaging Healthcare Co., Ltd. | 2019-11-20 |
| RSI-MRI+ (K191278) | Multimodal Imaging Services Corporation (Dba Healthlytix) | 2019-11-19 |
| Dolphin Medical Imaging USB Ultrasound System (K192573) | Dolphin Medical Imaging, LLC | 2019-11-19 |
| Soltus 500 (K192936) | Sedecal., Sa. | 2019-11-15 |
| EchoGo Core (K191171) | Ultromics, Ltd. | 2019-11-13 |
| IDENTIFY (K192968) | Varian Medical Systems, Inc. | 2019-11-12 |
| FDR D-EVO III flat panel detector system (K192932) | Fujifilm Corporation | 2019-11-12 |
| OEC Elite (K192819) | Ge Oec Medical Systems, Inc. | 2019-11-08 |
| QuantX Breast MRI Biopsy Guidance Plugin (K191959) | Qlarity Imaging | 2019-11-08 |
| DIGITAL RADIOGRAPHY CXDI-702C Wireless, DIGITAL RADIOGRAPHY CXDI-402C Wireless (K192632) | Canon, Inc. | 2019-11-07 |
| MEDIP PRO (K191026) | Medical IP Co., Ltd. | 2019-11-07 |
| SOMATOM X.cite (K191891) | Siemens Medical Solutions USA, Inc. | 2019-11-06 |
| Cleerly Labs (K190868) | Cleerly, Inc. | 2019-11-05 |
| KOALA (K192109) | Ib Lab GmbH | 2019-11-05 |
| DRX-Evolution/Plus with Dual Energy (K190330) | Carestream Health, Inc. | 2019-11-04 |
| FDR SE Lite (K192440) | Fujifilm Corporation | 2019-11-01 |
| VisionX 2.4 (K192743) | Durr Dental SE | 2019-10-31 |
| mediCAD Web (K183412) | Medicad Hectec GmbH | 2019-10-31 |
| Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems (K191007) | Supersonic Imagine | 2019-10-25 |
| MU2net (K191944) | Dosisoft | 2019-10-24 |
| Revolution Maxima, Revolution Ace (K192686) | Ge Hangwei Medical Systems Co., Ltd. | 2019-10-24 |
| Upgrade Kit MR GUI PRO, MrJ 3300 Plus (K192690) | Asg Superconductors S.P.A. | 2019-10-24 |
| ACUSON NX3 Diagnostic Ultrasound System / ACUSON NX3 Elite Diagnostic Ultrasound System (K192835) | Siemens Medical Solutions USA, Inc. | 2019-10-22 |
| RCT800 (K192737) | Ray Co., Ltd. | 2019-10-22 |
| RTHawk, HeartVista Cardiac Package (K183274) | Heartvista, Inc. | 2019-10-18 |
| QT Scanner 2000 Model A (K190646) | Qt Ultrasound, LLC | 2019-10-18 |
| Synapse 3D Blood Flow Analysis (K191544) | Fujifilm Corporation | 2019-10-18 |
| SmartCeph (K190162) | Ortho2, LLC | 2019-10-17 |
| Merge PACS (K192455) | Merge Healthcare Incorporated | 2019-10-17 |
| Voxel Dosimetry™ v1.0 (K191216) | Hermes Medical Solutions AB | 2019-10-17 |
| DigiX FDX (K192541) | Allengers Medical Systems Limited | 2019-10-16 |
| Focus 35C Detector, Trimax 35C Detector (K192512) | Iray Technology Taicang , Ltd. | 2019-10-16 |
| Ventripoint Medical System Plus (VMS+) 3.0 (K191493) | Ventripoint Diagnostics , Ltd. | 2019-10-16 |
| SURGICAL MICROSCOPE SYSTEM ORBEYE with IR (K190772) | Olympus Medical Systems Corp. | 2019-10-10 |
| DynaCAD (K192200) | Invivo Corporation | 2019-10-09 |
| Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000 (K190314) | Mednovel Technology, Ltd. | 2019-10-09 |
| CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™ (ROI Assembly) (K191713) | Omega Medical Imaging, LLC | 2019-10-04 |
| Safergel Sterile Ultrasound Gel (K190591) | Safersonic Us, Inc. | 2019-10-04 |
| ProFound AI Software V2.1 (K191994) | Icad, Inc. | 2019-10-04 |
| XACT Robotic System (K191332) | Xact Robotics, Ltd. | 2019-10-03 |
| Ablation Confirmation (K192427) | Neuwave Medical, Inc. | 2019-10-03 |
| EVS 4343A, EVS 4343AG, EVS 3643A, EVS 3643AG (K192400) | DRTECH Corporation | 2019-10-03 |
| Mobius3D (K192424) | Varian Medical Systems, Inc. | 2019-10-03 |
| RTapp (K191610) | Segana, LLC | 2019-10-01 |
| Signa Voyager, Signa Voyager Quantum (K192426) | Ge Healthcare (Tianjin) Company Limited | 2019-10-01 |
| DIAMOND-5A/6A/8A (K192453) | DRGEM Corporation | 2019-10-01 |
| ExactVu High Resolution Micro-Ultrasound System (K192303) | Exact Imaging, Inc. | 2019-10-01 |
| Radiance 330 Proton Beam Therapy System (K191521) | Protom International Holding Corporation | 2019-09-27 |
| Smart-C (K190024) | Turner Imaging Systems, Inc. | 2019-09-27 |
| NuVasive NuvaLine (K192435) | Nu Vasive, Incorporated | 2019-09-26 |
| GXR-Series Diagnostic X-Ray System (K192364) | DRGEM Corporation | 2019-09-26 |
| StoneChecker (K191530) | Imaging Biometrics, LLC | 2019-09-26 |
| PhoeniX (K192011) | Sedecal., Sa. | 2019-09-25 |
| Thermoplastic Masks (K192102) | Aktina Medical Corporation | 2019-09-25 |
| SeeFactorCT3 (K190856) | Epica International, Inc. | 2019-09-20 |
| Merge Cardio (K192276) | Merge Healthcare Incorporated | 2019-09-20 |
| CivaDerm (K191324) | Civatech Oncology, Inc. | 2019-09-20 |
| syngo.CT Extended Functionality (K192402) | Siemens Medical Solutions USA, Inc. | 2019-09-20 |
| GEHC DXA Bone Densitometers with enCORE version 18 (K191112) | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2019-09-19 |
| RS80 EVO Diagnostic Ultrasound System (K192030) | Samsung Medison Co., Ltd. | 2019-09-19 |
| Syngo.Via RT Image Suite (K192065) | Siemens Medical Solutions USA, Inc. | 2019-09-18 |
| Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0 (K191663) | Canon Medical Systems Corporation | 2019-09-18 |
| InnoSight Diagnostic Ultrasound System (K192254) | Qisda Corporation | 2019-09-18 |
| Sim&Size (K190049) | Sim&Cure | 2019-09-17 |
| SubtleMR (K191688) | Subtle Medical, Inc. | 2019-09-16 |
| SCENARIA View (K190841) | Hitachi Healthcare Americas | 2019-09-13 |
| PROBEAT-CR (K191801) | Hitachi , Ltd. | 2019-09-13 |
| SIS Software Version 3.6.0 (K192304) | Surgical Information Sciences, Inc. | 2019-09-13 |