| Mars 1417X Wireless Digital Flat Panel Detector (K210316) | Iray Technology Taicang , Ltd. | 2021-03-03 |
| SonoEye P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital Color Doppler Palm Ultrasound System (K201965) | CHISON Medical Technologies Co., Ltd. | 2021-03-02 |
| Mars1717X Wireless Digital Flat Panel Detector (K210314) | Iray Technology Taicang , Ltd. | 2021-03-02 |
| MaxFOV 2 (K203617) | Ge Medical Systems, LLC | 2021-03-02 |
| MRI PPG Patient Cable (K203653) | Ivy Biomedical Systems, Inc. | 2021-03-02 |
| SonoEye P3/ SonoEye V3/ Sono Eye G3 Digital Color Doppler Palm Ultrasound System (K201968) | CHISON Medical Technologies Co., Ltd. | 2021-02-26 |
| SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound System (K201967) | CHISON Medical Technologies Co., Ltd. | 2021-02-26 |
| Cuptimize (K203651) | Cuptimize, Inc. | 2021-02-26 |
| SubtleMR (K203182) | Subtle Medical, Inc. | 2021-02-26 |
| Bladder Scanner (Model: M3, M3-HD, M4, M4-HD) (K201316) | Suzhou Peaksonic Medical Technology Co., Ltd. | 2021-02-26 |
| Spectral CT (K203020) | Philips Medical Systems Nederland B.V. | 2021-02-26 |
| SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound System (K201971) | CHISON Medical Technologies Co., Ltd. | 2021-02-25 |
| SonoEye P6/ SonoEye V6/ SonoEye G6 Digital Color Doppler Palm Ultrasound System (K201969) | CHISON Medical Technologies Co., Ltd. | 2021-02-25 |
| EchoS Family (K202514) | Echolight S.P.A | 2021-02-25 |
| OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System (K203578) | Perimeter Medical Imaging Ai, Inc. | 2021-02-25 |
| NinesMeasure (K202990) | Nines, Inc. | 2021-02-25 |
| Veolity (K201501) | MeVis Medical Solutions AG | 2021-02-23 |
| ClarifEye R1.0, ClarifEye Needle (K201743) | Philips Medical Systems Nederlands B.V. | 2021-02-23 |
| PreXion3D Explorer PRO (K203784) | Prexion Corporation | 2021-02-23 |
| Lumify Diagnostic Ultrasound System (K203406) | Philips Ultrasound, Inc. | 2021-02-23 |
| Monaco Rtp System (K202789) | Elekta Solutions AB | 2021-02-23 |
| Disposable Intraoperative Probe (DIOP8) (K201425) | Huntleigh Healthcare Limited | 2021-02-19 |
| MyPAO Planning Report (K200589) | Medacta International S.A. | 2021-02-19 |
| TruPlan (K202212) | Circle Cardiovascular Imaging, Inc. | 2021-02-19 |
| X-ray Flat Panel Detectors/CareView 3600RF (K202995) | Careray Digital Medical System Co., Ltd. | 2021-02-19 |
| Green X 18(Model : PHT-75CHS) (K210329) | VATECH Co., Ltd. | 2021-02-18 |
| 3D Accuitomo 150N (K201378) | J. Morita USA, Inc. | 2021-02-18 |
| PhantomMSK Hip (K210136) | OrthoGrid Systems, Inc. | 2021-02-18 |
| VesselIQ Xpress (K200626) | GE Medical Systems SCS | 2021-02-16 |
| Vitrea Software Package, VSTP-001A (K203312) | Canon Medical Systems Corporation | 2021-02-16 |
| 4D Integrated Treatment Console (K203766) | Varian Medical Systems, Inc. | 2021-02-12 |
| Synapse 3D, Synapse 3D Base Tools v6.1 (K203103) | Fujifilm Corporation | 2021-02-09 |
| SmartCT R1.0 (K201583) | Philips Medical Systems Nederland B.V. | 2021-02-09 |
| Cios Spin (K210054) | Siemens Medical Systems USA, Inc. | 2021-02-05 |
| Cios Alpha (K210055) | Siemens Medical Solutions USA, Inc. | 2021-02-05 |
| Bonelogic (K203290) | Disior, Ltd. | 2021-02-05 |
| LVivo Software Application (K210053) | Dia Imaging Analysis, Ltd. | 2021-02-05 |
| QUIBIM Precision Prostate (qp-Prostate) (K203582) | Quibim S.L. | 2021-02-04 |
| Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR (K203553) | Canon Medical Systems Corporation | 2021-02-02 |
| EzRay M (Model: VMX-P300) (K203667) | VATECH Co., Ltd. | 2021-02-02 |
| CTxx85 CT Scanner (K201231) | Analogic Corporation | 2021-02-02 |
| Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems (K203537) | Sedecal., Sa. | 2021-02-01 |
| i_Space 1.5T Superconducting Magnetic Resonance Imaging System (K192650) | Mri Division,Beijing Wandong Medical Technology Co., Ltd. | 2021-01-29 |
| Visage Breast Density (K201411) | Visage Imaging GmbH | 2021-01-29 |
| General Radiography CXDI-CS01 (K203849) | Canon, Inc. | 2021-01-26 |
| IBM iConnect Access (K203104) | Merge Healthcare Incorporated | 2021-01-26 |
| Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3 Super, Acclarix AX25, Acclarix AX28, Acclarix AX2, Acclarix AX2 Exp, Acclarix AX2 Super, Acclarix AX15, Acclarix AX18, Acclarix LX3, Acclarix LX3 Exp, Acclarix LX3 Super, Acclarix LX25 and Acclarix LX28 (K202856) | Edan Instruments, Inc. | 2021-01-25 |
| Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory (K202742) | Viasonix , Ltd. | 2021-01-25 |
| vatech A9 (Model : PHT-30CSS) (K203797) | VATECH Co., Ltd. | 2021-01-25 |
| Platinum dRF Imaging System (K203010) | Apelem-Dms Group | 2021-01-22 |
| DIR 800 (K202391) | Aesculap, Inc. | 2021-01-21 |
| IntraSight Mobile (K203719) | Volcano Corporation | 2021-01-19 |
| ViewPoint 6 (K203677) | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2021-01-15 |
| AccuBrain (K202847) | Brainnow Medical Technology Limited | 2021-01-15 |
| Veuron-Brain-pAb (K203142) | Heuron Co., Ltd. | 2021-01-15 |
| Vantage Orian 1.5T, MRT-1550, V6.0 (K202767) | Canon Medical Systems Corporation | 2021-01-15 |
| uAI EasyTriage-Rib (K193271) | Shanghai United Imaging Intelligence Co., Ltd. | 2021-01-15 |
| ART-Plan (K202700) | Therapanacea | 2021-01-14 |
| Mobius3D (K203669) | Varian Medical Systems, Inc. | 2021-01-14 |
| Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i (K201836) | Canon Medical Systems Corporation | 2021-01-12 |
| Hepatica v1 (Hepatica v1.0.0) (K203280) | Perspectum, Ltd. | 2021-01-12 |
| Micro C Medical Imaging System, M01 (K203658) | Oxos Medical, Inc. | 2021-01-12 |
| LOGIQ P10, LOGIQ P9, LOGIQ P8 (K203114) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2021-01-08 |
| BrainInsight (K202414) | Hyperfine Research, Inc. | 2021-01-07 |
| MULTIX Impact (K203345) | Siemens Medical Solutions USA, Inc. | 2021-01-07 |
| MULTIX Impact C (K203340) | Siemens Medical Solutions USA, Inc. | 2021-01-06 |
| SR-1000 Portable DR Imaging System, SR-1000S Portable DR Imaging System (K202350) | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) | 2021-01-06 |
| Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles (K202267) | Isoray Medical, Inc. | 2020-12-31 |
| Sim&Size (K202322) | Sim&Cure | 2020-12-31 |
| Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc MACH20 Ultrasonic Diagnostic Systems (K202455) | Supersonic Imagine | 2020-12-29 |
| XR-MX/1000 (K200965) | Karl Storz Endoscopy America, Inc. | 2020-12-29 |
| BriefCase (K203508) | Aidoc Medical , Ltd. | 2020-12-29 |
| Venue Fit (K203137) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2020-12-29 |
| Image Quality Analyzer (IQA) (K200422) | Visionquest Biomedical, Inc. | 2020-12-24 |
| ControlRad Select Model Z (K202431) | Controlrad, Inc. | 2020-12-23 |
| OmniTom Elite (K202526) | Neurologica Corporation, A Subsidiary of Samsung Electronics | 2020-12-23 |
| SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging System (K202353) | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) | 2020-12-23 |
| Affinity (K202882) | Hermes Medical Solutions AB | 2020-12-23 |
| Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-X (K203281) | Medphoton GmbH | 2020-12-22 |
| Cios Flow (K203504) | Siemens Medical Solutions USA, Inc. | 2020-12-22 |
| AI Metrics (K202229) | Ai Metrics, LLC | 2020-12-22 |
| MOSAIQ Oncology Information System (K203172) | Elekta Solutions AB | 2020-12-18 |
| SQuEEZ Software (K201250) | Cardiowise, Inc. | 2020-12-18 |
| ClearRT Helical kVCT for the Radixact Treatment Delivery System (K202412) | Accuray Incorporated | 2020-12-18 |
| EchoGo Pro (K201555) | Ultromics, Ltd. | 2020-12-18 |
| Alphenix, INFX-8000V/B, /S, V9.1 (K203551) | Canon Medical Systems Corporation | 2020-12-18 |
| BeamSite (K200940) | Doseoptics, LLC | 2020-12-11 |
| Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-I (K203042) | Canon Medical Systems Corporation | 2020-12-10 |
| Deep Learning Image Reconstruction for Gemstone Spectral Imaging (K201745) | Ge Medical Systems, LLC | 2020-12-10 |
| HepaFat-AI (K201039) | Resonance Health Analysis Services Pty, Ltd. | 2020-12-07 |
| Nucleus.io (K203249) | Nucleushealth, LLC | 2020-12-04 |
| HealthJOINT (K202487) | Zebra Medical Vision, Ltd. | 2020-12-04 |
| CombiDiagnost R90 (K203087) | Philips Medical Systems Dmc GmbH | 2020-12-03 |
| Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR (K203053) | Canon Medical Systems Corporation | 2020-12-02 |
| Lux 35 Detector (K203159) | Carestream Health | 2020-12-02 |
| Planmeca Romexis (K200572) | Planmeca Oy | 2020-12-02 |
| Apolo D / Apolo S (K202388) | Vmi Tecnologias Ltda | 2020-12-01 |
| The Multimodality Advanced Vessel Analysis (K203216) | Philips Medical Systems Nederland B.V. | 2020-11-25 |
| MiniCAT 2D (K201825) | Xoran Technologies, LLC | 2020-11-20 |
| Optimized Positioning System (OPS) Insight (K202805) | Corin USA | 2020-11-20 |