| Symbia T16, Symbia Intevo 16 and Symbia Intevo Bold (K173023) | Siemens Medical Solutions USA, Inc. | 2017-11-17 |
| MobileDiagnost M50 (K173187) | Philips India Limited | 2017-11-16 |
| OEC Elite (K172550) | Ge Oec Medical Systems, Inc. | 2017-11-16 |
| LessRay System (K173314) | Nu Vasive, Incorporated | 2017-11-16 |
| SIRIO H3 (K163643) | Masmec Spa | 2017-11-16 |
| U50 Diagnostic Ultrasound System (K173003) | Edan Instruments, Inc. | 2017-11-15 |
| jFit Surgical Planner (K173329) | Jointvue, LLC | 2017-11-15 |
| Biograph mMR with mMR Angio Transfer Option (K172531) | Siemens Medical Solutions USA, Inc. | 2017-11-14 |
| FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) (K173034) | Echosens | 2017-11-14 |
| Planmeca Romexis (K171385) | Planmeca Oy | 2017-11-14 |
| Dolphin/IQ and Dolphin/4D (K170859) | Viasonix , Ltd. | 2017-11-14 |
| Televere Podiatry Digital Imaging System (K172124) | Televere Systems | 2017-11-09 |
| Philips CT Big Bore (K171850) | Philips Medical Systems (Cleveland), Inc. | 2017-11-09 |
| Aquarius 8600 1417WCI; Aquarius 8600 1717WCI (K173273) | Imaging Dynamics Company , Ltd. | 2017-11-09 |
| BioZorb Marker GOLD / LP Marker GOLD (K171467) | Focal Therapeutics | 2017-11-09 |
| OEC One (K172700) | Ge Hualun Medical Systems Co. , Ltd. | 2017-11-09 |
| Surgical Planning Software version 1.1 (K173247) | Ortho Kinematics, Inc. | 2017-11-08 |
| RadiForce RX560, RX560-AR (K172738) | Eizo Corporation | 2017-11-08 |
| SurgicalPreview (K171534) | Endo Vantage, LLC | 2017-11-08 |
| UltraVision 2 Diagnostic Ultrasound System (K173265) | Winprobe Corporation | 2017-11-07 |
| CSMC Cardiac Suite (K172609) | Cedars-Sinai Medical Center | 2017-11-03 |
| Vivid E80, Vivid E90, Vivid E95 (K173341) | GE Medical Systems | 2017-11-02 |
| IMAGEnet 6 Ophthalmic Data System (K171370) | Topcon Corporation | 2017-11-01 |
| ALOKA ARIETTA 850 (K171708) | Hitachi Healthcare Americas Corporation | 2017-10-31 |
| XIDF-AWS801, Angio Workstation, V7.0 (K172646) | Toshibamedical Systems Corporation | 2017-10-30 |
| SenoBright HD (K172404) | GE Healthcare | 2017-10-30 |
| 2MP LCD Monitor (G22S+, G22SP+, C22S+, C22SP+) (K172815) | Shenzhen Beacon Display Technology Co., Ltd. | 2017-10-27 |
| SOFTDISO (K170345) | Best Nomos | 2017-10-27 |
| Infinitt PACS 7.0 (K172803) | Infinitt Healthcare Co., Ltd. | 2017-10-27 |
| Biim Diagnostic Ultrasound System (K173138) | Biim Ultrasound AS | 2017-10-27 |
| LINACwatch, LinacView (K172534) | Qualiformed Sarl | 2017-10-27 |
| C5 Diagnostic Ultrasound System (K171926) | Guangzhou Sonostar Technologies Co., Ltd. | 2017-10-27 |
| ASPIRE Cristalle (K173132) | Fujifilm Medical Systems U.S.A, Inc. | 2017-10-27 |
| OrthoVision (K173094) | Ewoosoft Co., Ltd. | 2017-10-26 |
| SunCHECK (K170307) | Sun Nuclear Corporation | 2017-10-25 |
| M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound (K172970) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2017-10-25 |
| Advance Medical Designs, Inc. Sterile Ultrasound Gel (K163050) | Advance Medical Designs, Inc. | 2017-10-25 |
| CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2 Installation Kit (K172455) | Volcano Corporation | 2017-10-25 |
| Dynamic Coronary Roadmap 2.0 (K172307) | Philips Medical Systems Nederland B.V. | 2017-10-24 |
| Nexus DR Digital X-ray Imaging System (with PaxScan 4343RC and PaxScan 4343Rv3) (K172951) | Varex Imaging Corporation | 2017-10-24 |
| BR-FHUS Viewer 1.0 (K171709) | Taihao Medical, Inc. | 2017-10-20 |
| OCTAVIUS I, OCTAVIUS II, OCTAVIUS III, OCTAVIUS 4D (K160405) | Ptw-Freiburg Physikalisch-Technische-Werkstaetten | 2017-10-20 |
| Quantra (K163623) | Hologic, Inc. | 2017-10-20 |
| Discovery XR656 HD (K172869) | Ge Hualun Medical Systems Co. , Ltd. | 2017-10-20 |
| Adani MammoScan (K172027) | Adani | 2017-10-20 |
| Accuro (K171594) | Rivanna Medical, LLC | 2017-10-20 |
| OrthoView 7.2 (K171068) | Meridian Technique, Ltd. | 2017-10-18 |
| Curve Image 2.0 PACS (K173101) | Curve Dental, Ltd. | 2017-10-18 |
| M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound System (K171579) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2017-10-18 |
| DX-D Imaging Package (K172784) | Agfa Healthcare N.V. | 2017-10-13 |
| Galaxy R Digital Radiography Upgrade (K172435) | Medien International Co, Ltd. | 2017-10-13 |
| Aquarius 8600 1417TG and Aquarius 8600 1717TG (K171169) | Imaging Dynamics Company , Ltd. | 2017-10-12 |
| MAGNETOM Terra (K170840) | Siemens Medical Solutions USA, Inc. | 2017-10-12 |
| SONON Ultrasound Imaging System, Model: 300L (K170085) | Healcerion Co., Ltd. | 2017-10-12 |
| SKR 3000 (K172793) | Konica Minolta, Inc. | 2017-10-12 |
| Edge Air Digital Flat Panel X-ray Detector (K172681) | Osko, Inc. | 2017-10-06 |
| Aquilion Prime SP, TSX-303B/1, v8.4 (K172188) | Toshiba Medical Systems Coroporation | 2017-10-06 |
| Ingenuity TF (K172406) | Philips Medical Systems (Cleveland), Inc. | 2017-10-06 |
| Edge Digital Flat Panel X-ray Detector (K172682) | Osko, Inc. | 2017-10-06 |
| LinkQuest Diagnostic Ultrasound System model SQ860 (K172059) | Linkquest, Inc. | 2017-10-05 |
| Aquarius 8600 1417WC (K171175) | Imaging Dynamics Company , Ltd. | 2017-10-05 |
| SyncVision System (K172574) | Volcano Corporation | 2017-10-05 |
| Vitrea Advanced Visualization, Version 7.6 (K172855) | Vital Images, Inc. | 2017-10-05 |
| Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System (K172607) | Philips Health Care | 2017-10-04 |
| BR-FHUS Navigation 1.0 (K171309) | Taihao Medical, Inc. | 2017-09-29 |
| Photoelectric Therapy System (K172080) | Xstrahl, Ltd. | 2017-09-29 |
| Voluson E6, Voluson E8, Voluson E10 (K172342) | GE Healthcare | 2017-09-29 |
| ASPIRE Bellus II (K171463) | Fujifilm Medical Systems U.S.A, Inc. | 2017-09-29 |
| U2 Diagnostic Ultrasound System (K172380) | Edan Instruments, Inc. | 2017-09-29 |
| CareView 1800Cw X-ray Flat Panel Detectors (K172581) | Careray Digital Medical System Co., Ltd. | 2017-09-26 |
| Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature Correction, Elements TRAM (K170816) | Brainlab AG | 2017-09-26 |
| Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664 (K171303) | University of Texas Medical School AT Houston, Texas | 2017-09-22 |
| EndoNaut (K171829) | Therenva Sas | 2017-09-21 |
| ZS3 Ultrasound System, z.one pro Ultrasound System (K171891) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2017-09-21 |
| S60 Series Digital Color Doppler Ultrasound System (K172082) | Sonoscape Medical Corp. | 2017-09-21 |
| Zap-X Radiosurgery System (K171804) | Zap Surgical Systems | 2017-09-21 |
| BladderScan Prime PLUS System (K172356) | Verathon Incorporated | 2017-09-15 |
| 3D Echo (K172513) | Jointvue, LLC | 2017-09-14 |
| Clarius Ultrasound System (K172385) | Clarius Mobile Health Corp. | 2017-09-14 |
| NeuViz Prime Multi-slice CT Scanner System (K171201) | Neusoft Medical Systems Co., Ltd. | 2017-09-13 |
| FibroScan 430 Mini+ (K172142) | Echosens | 2017-09-13 |
| Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System (K171233) | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. | 2017-09-12 |
| NeuroQuant (K170981) | Cortechs Labs, Inc. | 2017-09-07 |
| Poseidon Ultrasound System (K163510) | Butterfly Network, Inc. | 2017-09-06 |
| Senographe Pristina (K163302) | GE Healthcare | 2017-09-01 |
| Orthopantomograph OP300 (K163423) | Palodex Group OY | 2017-08-31 |
| Kelowna GYN and Crook Prostate Templates (K162533) | Varian Medical Systems, Inc. | 2017-08-31 |
| DUS-7000 Digital Color Doppler Ultrasound System (K172055) | Advanced Instrumentations, Inc. | 2017-08-31 |
| SyMRI (K162943) | Syntheticmr AB | 2017-08-29 |
| Sirius MRI Marker NS (K171487) | C4 Imaging, LLC | 2017-08-25 |
| OTIS Optical Coherence Tomography System (K171560) | Perimeter Medical Imaging, Inc. | 2017-08-25 |
| SKR 3000 (K171716) | Konica Minolta, Inc. | 2017-08-25 |
| VMA™ System version 3.0 (K172327) | Ortho Kinematics, Inc. | 2017-08-25 |
| RS80A Diagnostic Ultrasound System (K171048) | Samsung Medison Co., Ltd. | 2017-08-24 |
| RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review (K170750) | Brainlab AG | 2017-08-24 |
| OKI Surgical Planning Software (K171617) | Ortho Kinematics, Inc. | 2017-08-22 |
| EzDent-i / E2 / Prora View (K172364) | Ewoosoft Co., Ltd. | 2017-08-22 |
| NuVasive LessRay with Enhanced Tracking (K170800) | Nu Vasive, Incorporated | 2017-08-18 |
| ScannerSide DoseCheck (K171261) | Right Dose, Inc. | 2017-08-18 |
| Supria True64 (K171738) | Hitachi Healthcare Americas Corporation | 2017-08-18 |