| Vantage Galan 3T, MRT-3020/A7, V5.0 (K181593) | Canon Medical Systems Corporation | 2018-08-13 |
| ONIS-PACS (K181318) | Digitalcore Co., Ltd. | 2018-08-13 |
| AlignRT Plus (K181218) | Vision Rt, Ltd. | 2018-08-07 |
| Model WP-3840 and WP-3040 (K173848) | Cnmc Co., Inc. | 2018-08-07 |
| CubeVue (K181962) | Curvebeam, LLC | 2018-08-07 |
| Ingenia Ambition S and Ingenia Ambition X (K181479) | Philips Medical Systems Nederland B.V. | 2018-08-03 |
| Philips CT Big Bore Sliding Gantry Configuration (K181797) | Phillips Medical Systems (Cleveland), Inc. | 2018-08-03 |
| VirtuOst Vertebral Fracture Assessment (K171435) | O.N. Diagnostics, LLC | 2018-08-03 |
| Azurion R2.0 (K181830) | Philips Medical Systems Nederland B.V. | 2018-08-02 |
| miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP Viewer (K171977) | Hinacom Software and Technology, Ltd. | 2018-08-02 |
| ProVectra 3D Prime with VistaSoft (K181432) | Durr Dental SE | 2018-08-02 |
| Alphenix, INFX-8000C/B, V8.0 (K181804) | Canon Medical Systems Corporation | 2018-08-02 |
| Ultrasound Scanner System bk2300 (K180737) | Bk Medical Aps | 2018-08-01 |
| BriefCase (K180647) | Aidoc Medical , Ltd. | 2018-08-01 |
| TE7/TE5 Diagnostic Ultrasound System (K180912) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2018-07-30 |
| RCT800 (K181452) | Ray Co., Ltd. | 2018-07-27 |
| EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound System (K181485) | Philips Ultrasound, Inc. | 2018-07-27 |
| Alphenix, INFX-8000V/B, V8.0 (K181670) | Canon Medical Systems Corporation | 2018-07-25 |
| Quantitative Total Extensible Imaging (QTxI) (K173444) | Aiq Solutions, Inc. | 2018-07-23 |
| GR40CW (K181631) | Samsung Electronics Co., Ltd. | 2018-07-20 |
| Digital Diagnostic Mobile X-ray System (K181626) | Samsung Electronics Co., Ltd. | 2018-07-20 |
| GC85A (K181629) | Samsung Electronics Co., Ltd. | 2018-07-20 |
| DentiqGuide (K180629) | 3D Industrial Imaging Co., Ltd. | 2018-07-19 |
| Image Filing Software NAVIS-EX (K181345) | Nidek Co., Ltd. | 2018-07-19 |
| Ultimax-i, DREX-UI80 (V1.60) (K181834) | Canon Medical Systems Corporation | 2018-07-19 |
| ACCUSYTE 3D Fiducial Marker (K180027) | Radiation Products, LLC | 2018-07-18 |
| ARIETTA 65 (K181376) | Hitachi Healthcare Americas Corporation | 2018-07-18 |
| Cook-Swartz Doppler Flow Probe (K171272) | Cook Incorporated | 2018-07-17 |
| Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System (K181016) | Welch Allyn, Inc. | 2018-07-16 |
| Aquarius 8600 Digital Radiography Sensor (K181565) | Biokinemetrics, Inc. | 2018-07-13 |
| Intelli-C (K173631) | Nrt X-Ray A/S | 2018-07-11 |
| 16ch Foot/ Ankle SPEEDER (K181697) | Quality Electrodynamics, LLC | 2018-07-11 |
| NTU-USB Ultrasound USB Box (K173486) | National Taiwan University | 2018-07-11 |
| Transcranial Doppler Ultrasound System (K173801) | Shenzhen Delica Medical Equipment Co., Ltd. | 2018-07-11 |
| Uscan (K181574) | EchoNous, Inc. | 2018-07-10 |
| Ceevra Reveal 2.0 (K173274) | Ceevra, Inc. | 2018-07-10 |
| Pseudo-Patient (K180697) | Rtsafe, Inc. | 2018-07-10 |
| Workflow Box (K181572) | Mirada Medical, Ltd. | 2018-07-10 |
| Disposable guides KDNG00 (K180970) | Koelis | 2018-07-10 |
| 3D Bolus Software (K180289) | 3D Bolus, Inc. | 2018-07-10 |
| FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) (K181547) | Echosens | 2018-07-09 |
| GammaTile (K180515) | Isoray Medical, Inc. | 2018-07-06 |
| XRpad2 4343 HWC-M Flat Panel Detector (K181526) | Varex Imaging Corporation | 2018-07-03 |
| Proton Positioing and Immobilization Devices (K180021) | Medtec Inc Dba Civco Medical Solutions and Civco Radiotherap | 2018-06-29 |
| Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf Collimator (K181404) | Varian Medical Systems, Inc. | 2018-06-28 |
| uDR 592h, uDR 596i (K181413) | Shanghai United Imaging Healthcare Co., Ltd. | 2018-06-27 |
| CALLISTO eye (K180858) | Carl Zeiss Meditec, AG | 2018-06-27 |
| DenSeeMammo (K173574) | Statlife | 2018-06-26 |
| SpaceOAR System (K181465) | Augmenix, Inc. | 2018-06-25 |
| Vscan Extend (K180995) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2018-06-25 |
| MIM - SPECTRA Quant (K180815) | Mim Software, Inc. | 2018-06-22 |
| Shear Wave Quantificational Ultrasound Diagnostic System (K173595) | Wuxi Hisky Medical Technologies Co., Ltd. | 2018-06-22 |
| Eclipse II (K180809) | Carestream Health, Inc. | 2018-06-21 |
| sterEOS Workstation (K172346) | Eos Imaging | 2018-06-19 |
| Prodiva 1.5T CX and Prodiva 1.5T CS R5.4 (K173507) | Philips Healthcare (Suzhou) Co., Ltd. | 2018-06-15 |
| Fusion Bx 2.0 (K181290) | Focal Healthcare, Inc. | 2018-06-15 |
| EchoMD Automated Ejection Fraction Software (K173780) | Bay Labs, Inc. | 2018-06-14 |
| MRIaudio PREM System (K180100) | Mriaudio | 2018-06-14 |
| Ysio Max (K181279) | Siemens Medi Cal Solutions, Inc. | 2018-06-13 |
| HealthCCS (K172983) | Zebra Medical Vision, Ltd. | 2018-06-13 |
| PEDRA-17F Digital Flat Panel X-ray Detector (K180989) | Radisen, Inc. | 2018-06-13 |
| EcoVue Sterile and Non-Sterile Ultrasound Gels (K181363) | H R Pharmaceuticals, Inc. | 2018-06-13 |
| SyMRI (K181093) | Syntheticmr AB | 2018-06-12 |
| HeartSee Cardiac P.E.T. Processing Software (K181343) | Bracco Diagnostics, Inc. | 2018-06-12 |
| LIAC HWL (K172961) | Sit Sordina Iort Technologies Spa | 2018-06-11 |
| 17HK700G-W (K180332) | Lg Electronics | 2018-06-08 |
| QLAB Advanced Quantification Software (K181264) | Philips Ultrasound, Inc. | 2018-06-07 |
| Orthopantomograph OP 3D (K180947) | Palodex Group OY | 2018-06-07 |
| uMR 560 (K180926) | Shanghai United Imaging Healthcare Co., Ltd. | 2018-06-06 |
| uMR 570 (K180925) | Shanghai United Imaging Healthcare Co., Ltd. | 2018-06-06 |
| LungQ Software (K173821) | Thirona Corporation | 2018-06-05 |
| Interventional Workspot (K181177) | Philips Medical Systems Nederland B.V. | 2018-05-31 |
| ACUSON SC2000 Diagnostic Ultrasound System (K181098) | Siemens Medical Solutions USA, Inc. | 2018-05-31 |
| AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10 (K180572) | Supersonic Imagine | 2018-05-29 |
| Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound System (K180862) | Edan Instruments, Inc. | 2018-05-24 |
| McKesson Cardiology (K181080) | Change Healthcare Israel , Ltd. | 2018-05-24 |
| CS 9600 (K181136) | Trophy | 2018-05-24 |
| PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels (K180976) | Pixxgen Corporation | 2018-05-24 |
| GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85 (K180543) | Samsung Electronics Co., Ltd. | 2018-05-24 |
| OsteoDetect (DEN180005) | Imagen Technologies, Inc. | 2018-05-24 |
| Biograph Vision (K180811) | Siemens Medical Solutions USA, Inc. | 2018-05-23 |
| NeuralBot (K180455) | Neural Analytics, Inc. | 2018-05-22 |
| MECALL CLISIS SYSTEMS, Discovery RF180 (K173395) | General Medical Merate S.P.A | 2018-05-21 |
| LaVid FMTS DIAGNOSTIC X-RAY SYSTEM (K180663) | Livermoretech, Inc. | 2018-05-18 |
| Eclipse Treatment Planning System (K181145) | Varian Medical Systems, Inc. | 2018-05-18 |
| Varian Cervical Sleeves (K172675) | Varian Medical Systems, Inc. | 2018-05-16 |
| Low Dose CT Lung Cancer Screening Option (K180901) | Hitachi Healthcare Americas | 2018-05-16 |
| 5D Viewer (K180883) | Samsung Medison Co., Ltd. | 2018-05-15 |
| VIVIX-S 1717V (K181003) | Vieworks Co., Ltd. | 2018-05-15 |
| Astroid Planning App (K173940) | .Decimal, LLC | 2018-05-15 |
| Clarius Ultrasound Scanner (K180799) | Clarius Mobile Health Corp. | 2018-05-14 |
| Ventripoint Medical System Plus (VMS+) (K173810) | Ventripoint Diagnostics , Ltd. | 2018-05-14 |
| Pristina Serena (K173576) | GE Healthcare | 2018-05-14 |
| HS40 Diagnostic Ultrasound System (K180409) | Samsung Medison Co., Ltd. | 2018-05-11 |
| LineUp (K180727) | Curvebeam, LLC | 2018-05-11 |
| RadiForce MX194 (K180961) | Eizo Corporation | 2018-05-10 |
| Faxitron VisionCT (K173309) | Faxitron Bioptics, LLC | 2018-05-09 |
| Halcyon (K181032) | Varian Medical Systems, Inc. | 2018-05-09 |
| Navi e/Navi s/Navi X Diagnostic Ultrasound System (K180461) | Shenzhen Wisonic Medical Technology Co. , Ltd. | 2018-05-09 |
| Invenia ABUS Viewer (K180641) | GE Healthcare | 2018-05-04 |