| Envision ultrasound pad and cover (K190802) | Civco Medical Solutions | 2019-05-24 |
| Bladder Scanner (Models: M2, M2-W, M1, M1-W) (K190769) | Suzhou Lischka Medtech Co., Ltd. | 2019-05-22 |
| LIAC S (K182374) | Sit Sordina Iort Technologies Spa | 2019-05-22 |
| HERA I10 Diagnostic Ultrasound System (K190444) | Samsung Medison Co., Ltd. | 2019-05-22 |
| DRX-Revolution Mobile X-ray System (K191025) | Carestream Health, Inc. | 2019-05-17 |
| Dolphin/IQ, Dolphin/4D and Dolphin/MAX (K191023) | Viasonix , Ltd. | 2019-05-16 |
| syngo.via (Version VB40A) (K191040) | Siemens Healthcare GmbH | 2019-05-16 |
| Topaz Mobile DR System (K183292) | DRGEM Corporation | 2019-05-15 |
| JUSHA-M550G/ JUSHA-M550/M550G/M550 LCD Monitor (K190848) | Nanjing Jusha Display Technology Co., Ltd. | 2019-05-14 |
| ControlRad Trace Model 8 (K183109) | Controlrad, Inc. | 2019-05-13 |
| SurgicalAR (K190764) | Medivis, Inc. | 2019-05-13 |
| 6400 Ultrasound System (MyLabX6, MyLabX7) (K190989) | Esaote, S.p.A. | 2019-05-10 |
| ExactVu High Resolution Micro-Ultrasound System (K190995) | Exact Imaging, Inc. | 2019-05-10 |
| MD-6000P Bladder Scanner (K182460) | MEDA Co., Ltd. | 2019-05-06 |
| Biograph Vision (K190900) | Siemens Medical Solutions USA, Inc. | 2019-05-06 |
| HealthPNX (K190362) | Zebra Medical Vision, Ltd. | 2019-05-06 |
| TOTIM Patient Cushion Immobilization System (K190894) | Essebi Medical Srl | 2019-04-30 |
| MRCAT Pelvis (K182888) | Philips Medical Systems MR Finland | 2019-04-30 |
| XmaruView V1 (Xmaru Chiroview, Xmaru Podview) (K190866) | Rayence Co., Ltd. | 2019-04-30 |
| Synapse Enterprise Viewer Version 1.0 (K183248) | Fujifilm Corporation | 2019-04-25 |
| MasteRad MX30 (K190601) | Medicatech USA | 2019-04-25 |
| Brainlab Elements Image Fusion Angio (K190042) | Brainlab AG | 2019-04-25 |
| hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS (K190496) | Cefla S.C. | 2019-04-24 |
| RAYSCAN a-Expert3D (K190812) | Ray Co., Ltd. | 2019-04-24 |
| Ez3D-i/E3 (K190791) | Ewoosoft Co., Ltd. | 2019-04-19 |
| Lung Vision System (K183593) | Bodyvision Medical , Ltd. | 2019-04-18 |
| “BRAXX” Esophageal Brachytherapy Applicator (K183332) | Braxx Biotech Co., Ltd. | 2019-04-16 |
| BriefCase (K190072) | Aidoc Medical , Ltd. | 2019-04-15 |
| SOMATOM Perspective, SOMATOM Scope/Scope Power, SOMATOM Emotion 16 (K183548) | Siemens Medical Solutions USA, Inc. | 2019-04-15 |
| NDOHD High Definition Imaging System (NDOHD) (K190420) | Altaravision, Inc. | 2019-04-15 |
| PreXion3D Explorer (K190320) | Prexion Corporation | 2019-04-15 |
| TEEClean(R) Automated TEE Probe Cleaner Disinfector with TEEZyme(R) Cleaner and TD-5(R) or TD-8(R) High Level Disinfectants (K182891) | Cs Medical, LLC | 2019-04-12 |
| RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review (K190664) | Brainlab AG | 2019-04-12 |
| 3T 32 Channel Head Coil (K182737) | Nova Medical, Inc. | 2019-04-12 |
| InstaRISPACS / InstaZFP / InstaMobi v5.0 (K182572) | Meddiff Technologies Pvt. , Ltd. | 2019-04-12 |
| Deep Learning Image Reconstruction (K183202) | Ge Medical Systems, LLC | 2019-04-12 |
| SyncVision System (K190626) | Volcano Corporation | 2019-04-12 |
| Eye Prime (K190786) | Ellex Medical Pty, Ltd. | 2019-04-11 |
| DP-10/DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging System (K183660) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2019-04-09 |
| Bone VCAR (BVCAR) (K183204) | GE Medical Systems SCS | 2019-04-08 |
| Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW) (K183606) | Scandidos AB | 2019-04-08 |
| VIVIX-S 1751S (K190611) | Vieworks Co., Ltd. | 2019-04-08 |
| JUSHA-C350G LCD Monitor, JUSHA-C350 LCD Monitor, C350G LCD Monitor, C350 LCD Monitor (K183496) | Nanjing Jusha Display Technology Co., Ltd. | 2019-04-08 |
| TCD-X (K182175) | Atys | 2019-04-05 |
| R190/R191 LCD Monitor (K183494) | Nanjing Jusha Display Technology Co., Ltd. | 2019-04-05 |
| DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System (K183377) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2019-04-04 |
| Pixx2430 Digital Diagnostic X-Ray Receptor Panel (K190691) | Pixxgen Corporation | 2019-04-04 |
| Ilumien Optis, Optis Integrated, Optis Mobile (K183320) | St. Jude Medical (Now Abbott Medical) | 2019-04-02 |
| ARIETTA 50 (K190248) | Hitachi Healthcare Americas | 2019-04-02 |
| 7400 Ultrasound Systems (K190447) | Navigant Consulting - on Behalf of Esaote S.P.A. | 2019-04-01 |
| DBSWIN and VISTAEASY Imaging Software (K190629) | Durr Dental SE | 2019-04-01 |
| Monaco RTP System (K190178) | Elekta, Inc. | 2019-03-29 |
| Thoracic VCAR with GSI Pulmonary Perfusion (K183210) | GE Medical Systems SCS | 2019-03-29 |
| CS-series-FP with Optional ROI Accessory CA-100S (K182834) | Omega Medical Imaging, LLC | 2019-03-29 |
| Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound System (K190186) | Edan Instruments, Inc. | 2019-03-28 |
| Mimics Medical (K183105) | Materialise NV | 2019-03-27 |
| OTIS Optical Coherence Tomography SYstem (K190404) | Perimeter Medical Imaging, Inc. | 2019-03-26 |
| Synapse PACS (K190232) | Fujifilm Corporation | 2019-03-26 |
| OARtrac System (K182395) | Radialdyne, LLC | 2019-03-22 |
| uWS-MR (K183164) | Shanghai United Imaging Healthcare Co., Ltd. | 2019-03-22 |
| ABSOLU (K183414) | Quantel Medical | 2019-03-20 |
| ACUSON S3000, S2000 Diagnostic Ultrasound System (K183575) | Siemens Healthineers | 2019-03-20 |
| SIS Software version 3.3.0 (K183019) | Surgical Information Sciences, Inc. | 2019-03-19 |
| MIM on Linux (K190379) | Mim Software, Inc. | 2019-03-19 |
| MOBILETT Elara Max (K182639) | Siemens Medi Cal Solutions, Inc. | 2019-03-15 |
| Vantage Galan 3T, MRT-3020/A9, V5.0 (K183657) | Canon Medical Systems Corporation | 2019-03-15 |
| SonialVision G4 (K190373) | Shimadzu Corporation | 2019-03-15 |
| FUJIFILM Sonosite Vevo MD Imaging System (K190476) | FUJIFILM Sonosite, Inc. | 2019-03-15 |
| PathVisionXL (K183142) | Faxitron Bioptics, LLC | 2019-03-14 |
| JUSHA-C620G LCD Monitor, JUSHA-C620 LCD Monitor, C620G LCD Monitor, C620 LCD Monitor (K183492) | Nanjing Jusha Display Technology Co., Ltd. | 2019-03-13 |
| BIOK7600W Wireless Flat Panel Detector (K190300) | Biokinemetrics, Inc. | 2019-03-13 |
| Enhanced Feature Software Pack CXDI Series (K190368) | Canon, Inc. | 2019-03-13 |
| BIOK7600 Flat Panel Detector (K190311) | Biokinemetrics, Inc. | 2019-03-13 |
| GammaTile (K190296) | Gt Medical Technologies | 2019-03-13 |
| RadiForce MX216 (K190153) | Eizo Corporation | 2019-03-08 |
| NewTom 5G XL (K183448) | Cefla S.C. | 2019-03-08 |
| EchoSure Diagnostic Ultrasound System (K190039) | Sonavex, Inc. | 2019-03-08 |
| Nexus DR Digital X-ray Imaging System (K190146) | Varex Imaging Corporation | 2019-03-08 |
| DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System (K190206) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2019-03-08 |
| RADMAX Digital Imaging Software (K182537) | DRGEM Corporation | 2019-03-08 |
| cmTriage (K183285) | Curemetrix, Inc. | 2019-03-08 |
| Visualase Thermal Therapy System (K181859) | Medtronic Navigation, Inc. | 2019-03-06 |
| PLANET Onco Dose (K182966) | Dosisoft | 2019-03-06 |
| Imagio Ultrasound Imaging System (K182628) | Seno Medical Instruments, Inc. | 2019-03-05 |
| ClearON Mobile (K183478) | Rayence Co., Ltd. | 2019-03-01 |
| EzDent-i / E2 / Prora View (K190087) | Ewoosoft Co., Ltd. | 2019-02-27 |
| uPMR 790 (K183014) | Shanghai United Imaging Healthcare Co., Ltd. | 2019-02-27 |
| FibermarX Radiopaque Tissue Marker (K190155) | Viscus Biologics, LLC | 2019-02-27 |
| GrayDuck Stent (K183374) | Poll Medical, LLC | 2019-02-26 |
| Zap-X Radiosurgery System (K183698) | Zap Surgical Systems | 2019-02-25 |
| IRIS 1.0 System (K182643) | Intuitive Surgical | 2019-02-22 |
| EMMA 1.5T MRI System (K183621) | Time Medical Limited | 2019-02-22 |
| Sensus Healthcare TVM Balloon Applicator (K190255) | Sensus Healthcare, Inc. | 2019-02-21 |
| Sensus TPS Workstation (K182665) | Sensus Healthcare, Inc. | 2019-02-21 |
| Sensus IORT System (K182641) | Sensus Healthcare, Inc. | 2019-02-21 |
| MRIdian Linac System (K181989) | Viewray, Incorporated | 2019-02-20 |
| RS85 Diagnostic Ultrasound System (K182932) | Samsung Medison Co., Ltd. | 2019-02-15 |
| MAGNETOM Terra (K183222) | Siemens Medical Solutions USA, Inc. | 2019-02-15 |
| PhantomMSK (K182332) | OrthoGrid Systems, Inc. | 2019-02-15 |
| MAGNETOM Aera (K190138) | Siemens Medical Solutions USA, Inc. | 2019-02-15 |