| ArcScan Insight 100 (K153416) | Arcscan, Inc. | 2016-02-02 |
| ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+ (K151426) | Scandidos AB | 2016-01-29 |
| Fusion Bx (K153166) | Focal Healtcare, Inc. | 2016-01-25 |
| ImagenSPECT (K152503) | Cardiovascular Imaging Technologies | 2016-01-25 |
| DG PACS (K152977) | Dicom Grid, Inc. | 2016-01-25 |
| Discovery NM/CT 670 CZT (K153402) | GE Healthcare | 2016-01-21 |
| HI VISION ASCENDUS, HV ASCENDUS, ASCENDUS (K153421) | Hitachi Aloka Medical America, Inc. | 2016-01-21 |
| Stereo 3D option for Vision Applications (K152352) | GE Medical Systems SCS | 2016-01-20 |
| CAS-One IR (K152473) | Cascination AG | 2016-01-20 |
| Stroke VCAR (K152584) | GE Medical Systems SCS | 2016-01-20 |
| SonoSite Edge II Ultrasound System (K153626) | FUJIFILM Sonosite, Inc. | 2016-01-20 |
| BR-ABVS Viewer 1.0 (K151075) | Taihao Medical, Inc. | 2016-01-15 |
| HEALTHMYNE (K153289) | Healthmyne, Inc. | 2016-01-15 |
| INFX-8000C, V6.20 (K152697) | Toshibamedical Systems Corporation | 2016-01-15 |
| S50 Digital Color Doppler Ultrasound System (K152854) | Sonoscape Medical Corp. | 2016-01-13 |
| Sonishield 100 Antimicrobial Ultrasound Gel (K151070) | Quotient Medical | 2016-01-13 |
| Cios Connect (K153147) | Siemens Medical Solutions USA, Inc. | 2016-01-12 |
| 3MP Color LCD Monitor, RadiForce RX350 (K153354) | Eizo Corporation | 2016-01-12 |
| Biograph Horizon PET/CT (K152880) | Siemens Medical Solutions USA, Inc. | 2016-01-12 |
| ImplantMax Software (K151152) | Saturn Imaging, Inc. | 2016-01-12 |
| INFX-8000V, V6.20 (K152696) | Toshibamedical Systems Corporation | 2016-01-12 |
| MRI Dynamic Analysis Plus (K153039) | Esaote, S.p.A. | 2016-01-08 |
| Volpara Imaging Software (K153427) | Matakina Technology, Ltd. | 2016-01-07 |
| LOGIQ V1/ LOGIQ V2 (K153037) | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2016-01-04 |
| Ez3D Plus (K152746) | Ewoosoft Co., Ltd. | 2016-01-03 |
| MAGNETOM Amira (K152283) | Siemens Medical Solutions USA, Inc. | 2015-12-24 |
| CareView 1800L (K153492) | Careray Digital Medical System Co., Ltd. | 2015-12-24 |
| MammoGRIP (K152038) | Women'S Imaging Solutions Enterprises, LLC | 2015-12-22 |
| SW v3.5 Install Kit, CORE Mobile, SW v3.5 Install Kit, CORE, SW v3.5 Install Kit, s5iz (K153369) | Volcano Corporation | 2015-12-22 |
| Philips Eleva Workspot with SkyFlow (K153318) | Philips Medical Systems Dmc GmbH | 2015-12-22 |
| Magnetic Reasonance Imaging System (K151074) | Jiangsu Magspin Instrument Co.,Ltd | 2015-12-22 |
| GR40CW (K153401) | Samsung Electronics Co., Ltd. | 2015-12-21 |
| HM70A Diagnostic Ultrasound System (K153408) | Samsung Medison Co., Ltd. | 2015-12-21 |
| Q Series Diagnostic Ultrasound System (K153085) | Chison Medical Imaging Co., Ltd. | 2015-12-21 |
| Intraluminal Applicator Set (K151022) | Varian Medical Systems, Inc. | 2015-12-17 |
| ClearVue850 Diagnostic Ultrasound System (K153480) | Philips Health Care | 2015-12-16 |
| Econsole1 (K152172) | DRTECH Corporation | 2015-12-14 |
| OTC12D AUTO RADIOGRAPHIC SYSTEM (K152767) | Del Medical, Inc. | 2015-12-14 |
| Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT Technology (K152554) | C.R. Bard, Inc. | 2015-12-14 |
| DR 600 (K152639) | Agfa Healthcare N.V. | 2015-12-11 |
| Panther StereoSeed (K143514) | Prowess, Inc. | 2015-12-11 |
| iViewDose R1.0 (K153011) | Elekta Limited | 2015-12-11 |
| PAPAYA 3D Plus (K150354) | Genoray Co., Ltd. | 2015-12-10 |
| Touch Ultrasound (K152467) | Carestream Health, Inc. | 2015-12-09 |
| Implant Studio 2015 (K152078) | 3Shape Medical A/S | 2015-12-04 |
| kVue Encompass SRS Insert (Encompass Insert), Encompass SRS Standalone (Encompass Device), Encompass SRS MRI Immobilization device (Encompass MRI Device, Encompass Intracranial Fibreplast Variable Perf Head Only Open View System, Encompass Intracranial Fibreplast Variable Perf Head Only Open View with 119 mm opening (K152321) | Qfix | 2015-12-04 |
| Aquilion ONE Vision with FIRST 1.0 (CCRS-001A) (K151673) | Toshibamedical Systems Corporation | 2015-11-27 |
| VidiStar HeartView (K152822) | Vidistar, LLC | 2015-11-25 |
| 4Sight (K152573) | Accutome, Inc. | 2015-11-25 |
| XIDF-AWS801, Angio Workstation, V6.20 (K152785) | Toshibamedical Systems Corporation | 2015-11-25 |
| Carestream DRX-1 System with DRX Plus 4343 Detectors (K153142) | Carestream Health, Inc. | 2015-11-25 |
| Permanent Beacon Transponder, Soft Tissue Beacon Transponder, Beacon Care Package - Soft Tissue (17G) (K152761) | Varian Medical Systems, Inc. | 2015-11-25 |
| CORVUS Radiation Therapy Planning System (K151469) | Best Nomos | 2015-11-25 |
| SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATON Emotion 6/16, SOMATOM Sensation 64/Sensation Cardiac , SOMATOM Perspective SOMATOM Scope/ Scope Power (K142955) | Siemens Medical Solutions USA, Inc. | 2015-11-24 |
| IQQA Guide (K151414) | Edda Technology | 2015-11-20 |
| ArcCHECK (K142617) | Sun Nuclear Corporation | 2015-11-20 |
| 8MP Color LCD Monitor, RadiForce RX850, RX850-AR (K152713) | Eizo Corporation | 2015-11-20 |
| BladderScan Prime System (K153101) | Verathon Incorporated | 2015-11-19 |
| 8 CH Knee SPEEDER (K152695) | Quality Electrodynamics, LLC | 2015-11-18 |
| Venue 50 (K152758) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2015-11-18 |
| Philips IntelliSpace Cardiovascular (K153022) | Philips Medical Systems Nethrlands BV | 2015-11-18 |
| DIVA ZSP5812CMI with QUBYX PerfectLum bundle (K152847) | Qubyx , Ltd. | 2015-11-17 |
| MD-2300S Ultrasonic A/B Scanner for Ophthalmology (K152318) | MEDA Co., Ltd. | 2015-11-17 |
| HICAT Air (K152661) | Hicat GmbH | 2015-11-16 |
| GUS ASTRA TEE Transesophageal Probe Reprocessor, GUS ASTRA VR Endovaginal/Endorectal Probe Reprocessor (K150504) | Pci Medical, Inc. | 2015-11-16 |
| UroNav (Version 2.0) (K153073) | Invivo Corporation | 2015-11-16 |
| Multitom Rax (K152928) | Siemens Medical Solutions USA, Inc. | 2015-11-13 |
| SOMATOM Emotion 6/16 (K151752) | Siemens Medical Solutions USA, Inc. | 2015-11-12 |
| FUJIFILM SonoSite iViz Ultrasound System (K152983) | FUJIFILM Sonosite, Inc. | 2015-11-12 |
| ATAL 9 (K152151) | Atlaim Corporation | 2015-11-10 |
| CareView 1500C/ CareView 1500L X-ray Flat Panel Detectors (K153058) | Careray Digital Medical System Co., Ltd. | 2015-11-10 |
| Thermofit (K151946) | Orfit Industries | 2015-11-09 |
| Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound System (K152567) | GE Healthcare | 2015-11-06 |
| superDimension Navigation System (K151376) | Covidien, LLC | 2015-11-05 |
| FDR D-EVO GL Flat Panel Detector System (K152138) | Fujifilm Medical System U.S.A., Inc. | 2015-11-05 |
| NeuViz 128 Multi-slice CT Scanner System (K151383) | Neusoft Medical Systems Co., Ltd. | 2015-11-04 |
| Ziostation2 (K151212) | Qi Imaging, LLC | 2015-11-04 |
| PROBEAT-V (K152592) | Hitachi, Ltd., Health Care Company | 2015-11-02 |
| HS70A Diagnostic Ultrasound System (K152962) | Samsung Medison Co., Ltd. | 2015-11-02 |
| syngo.CT Myocardial Perfusion (K150713) | Siemens Medical Solutions USA, Inc. | 2015-11-02 |
| Positron Emission Tomography (PET) and Computed Tomography (CT) System, Positron Emission Tomography (PET) and Computed Tomography (CT) System (K151403) | Neusoft Medical Systems Co., Ltd. | 2015-11-02 |
| SCENARIA Phase 3 Whole-body X-ray CT System (K150595) | Hitachi Medical Systems America, Inc. | 2015-10-30 |
| Philips Lumify Diagnostic Ultrasound System (K152899) | Philips Healthcare, Inc. | 2015-10-30 |
| Lung Analysis Software (K151283) | Vital Images, Inc. | 2015-10-30 |
| OPTIS Mobile System (K152120) | Lightlab Imaging, Inc. | 2015-10-29 |
| M9/M9CV/M9T Diagnostic Ultrasound System (K152543) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015-10-29 |
| Leksell Gamma Knife Perfexion (K151159) | Elekta Instrument AB | 2015-10-29 |
| SIGNA Pioneer (K153003) | GE Healthcare | 2015-10-27 |
| Varian Treatment (VTx) (K151882) | Varian Medical Systems, Inc. | 2015-10-26 |
| Volpara Imaging Software (K152028) | Matakina Technologies Limited | 2015-10-26 |
| Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D Smart (K152106) | VATECH Co., Ltd. | 2015-10-23 |
| Vantage Titan 3T (K152371) | Toshibamedical Systems Corporation | 2015-10-23 |
| Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System (K152763) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015-10-21 |
| EVS 3643 (K151942) | DRTECH Corporation | 2015-10-21 |
| MHI-TM2000 Linear Accelerator System, VERO, Imavis (K152867) | Mitsubishi Heavy Industries, Ltd. | 2015-10-21 |
| EOS System (K152788) | Eos Imaging | 2015-10-21 |
| GR40CW (K152094) | Samsung Electronics Co., Ltd. | 2015-10-16 |
| Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities (K150037) | Sensus Healthcare | 2015-10-16 |
| Visible Patient Suite (K151988) | Visible Patient, Sas | 2015-10-15 |
| MrOpen (K151466) | Paramed S.R.L. | 2015-10-15 |