| EPIQ Diagnostic Ultrasound System, 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 (K182857) | Philips Ultrasound, Inc. | 2018-11-09 |
| uWS-CT (K173001) | Shanghai United Imaging Healthcare Co., Ltd. | 2018-11-07 |
| uWS-MR (K172999) | Shanghai United Imaging Healthcare Co., Ltd. | 2018-11-07 |
| MAGNETOM Avanto, MAGNETOM Verio with software syngo MR E11D (K181613) | Siemens Medical Solutions USA, Inc. | 2018-11-06 |
| Vivid T8, Vivid T9 (K181934) | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2018-11-06 |
| icobrain (K181939) | Icometrix NV | 2018-11-06 |
| Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR (K181403) | GE Healthcare | 2018-11-02 |
| NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System (K182616) | Ninepoint Medical, Inc. | 2018-11-02 |
| Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System (K182596) | Canon Medical Systems Corporation | 2018-11-02 |
| Afina (K181501) | Neurovision Imaging, LLC | 2018-11-02 |
| Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology) (K180601) | Villa Sistemi Medicali S.P.A. | 2018-11-02 |
| Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound System (K182427) | Canon Medical Systems Corporation | 2018-11-02 |
| Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1 (K182679) | Canon Medical Systems Corporation | 2018-10-31 |
| Halifax Imaging Kit (K182880) | Halifax Biomedical, Inc. | 2018-10-31 |
| AVIEW (K171199) | Coreline Soft Co., Ltd. | 2018-10-31 |
| Cios Spin (K181550) | Siemens Medical Solutions USA, Inc. | 2018-10-30 |
| MAGNETOM Aera (K182299) | Siemens Medical Solutions USA, Inc. | 2018-10-26 |
| Accipiolx (K182177) | Maxq-Al , Ltd. | 2018-10-26 |
| Implant Planning Software (K173965) | Inteware Co., Ltd. | 2018-10-26 |
| PeekMed (K182464) | Peek Health, S.A. | 2018-10-25 |
| Vivid E80, Vivid E90, Vivid E95 (K181685) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2018-10-25 |
| Hybrid3D (K181468) | Hermes Medical Solutions AB | 2018-10-25 |
| Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech (K182281) | C. R. Bard | 2018-10-24 |
| Cios Alpha (K181560) | Siemens Medical Systems USA, Inc. | 2018-10-24 |
| GC70 (K182647) | Samsung Electronics Co., Ltd. | 2018-10-24 |
| Retina Workplace (K182318) | Carl Zeiss Meditec, Inc. | 2018-10-24 |
| GU60A, GU60A-65 (K182622) | Samsung Electronics Co., Ltd. | 2018-10-23 |
| Xperius Ultrasound System (K182529) | Philips Ultrasound, Inc. | 2018-10-23 |
| JiveX (K181964) | Visus Health IT GmbH | 2018-10-23 |
| GM Implant Tubes, Length Cutting Gauge (K172533) | Varian Medical Systems, Inc. | 2018-10-22 |
| Vantage Orian 1.5T, MRT-1550, V4.5 (K182282) | Canon Medical Systems Corporation | 2018-10-19 |
| EchoS (K180516) | Echolight S.P.A | 2018-10-19 |
| 1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, 1.5T 30ch AIR AA (K182590) | GE Healthcare | 2018-10-19 |
| UroNav (Version 3.0) (K182561) | Invivo Corporation | 2018-10-19 |
| MAGNETOM Vida (K181433) | Siemens Medical Solutions USA, Inc. | 2018-10-19 |
| Vivid S60N, Vivid S70N (K182450) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2018-10-19 |
| 14HK701G-W (K182348) | Lg Electronics.Inc | 2018-10-18 |
| RadiForce RX360, RX360-AR (K182591) | Eizo Corporation | 2018-10-18 |
| Wireless Digital Flat Panel Detector (K182550) | Iray Technology Taicang , Ltd. | 2018-10-17 |
| Wireless Digital Flat Panel Detector (K182551) | Iray Technology Taicang , Ltd. | 2018-10-17 |
| Arterys MICA (K182034) | Arterys, Inc. | 2018-10-17 |
| Alphenix, INFX-8000H/B, V8.0 (K182546) | Canon Medical Systems Corporation | 2018-10-17 |
| NvisionVLE Imaging System, NvisionVLE Optical Probe (K182261) | Ninepoint Medical, Inc. | 2018-10-16 |
| RCT700 (K182614) | Ray Co., Ltd. | 2018-10-16 |
| MAGNETOM Sola (K182129) | Siemens Medical Solutions USA, Inc. | 2018-10-12 |
| 3.0T Air MP M, 3.0T Air MP L (K182504) | Ge Healthcare Coils (Usa Instruments, Inc.) | 2018-10-12 |
| uMI 550 PET/CT System (K182237) | Shanghai United Imaging Healthcare Co., Ltd. | 2018-10-12 |
| E-CUBE 8 (K181617) | Alpinion Medical Systems Co., Ltd. | 2018-10-11 |
| OnePacs System (K181460) | Onepacs, LLC | 2018-10-11 |
| Ziostation2 (K181892) | Ziosoft, Inc. | 2018-10-09 |
| MAGNETOM Sola (K181322) | Siemens Medical Solutions USA, Inc. | 2018-10-05 |
| PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels (K182533) | Pixxgen Corporation | 2018-10-04 |
| CURA 16; ScintCare CT16 (K173076) | Fmi Medical Systems, Inc. | 2018-10-04 |
| Encompass SRS Headframe ; Encompass MR SRS Headframe (K182189) | Qfix | 2018-10-04 |
| uMR 790 (K181371) | Shanghai United Imaging Healthcare Co., Ltd. | 2018-10-03 |
| uMR 780 (K181370) | Shanghai United Imaging Healthcare Co., Ltd. | 2018-10-03 |
| BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes, and Length Assessment Device (K181903) | Varian Medical Systems, Inc. | 2018-10-03 |
| Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation Therapy Therapist v4.3.1_MR3 Patch, syngo Radiation Therapy Oncologist v4.3.1_MR3 Patch (K182050) | Siemens Medical Solutions USA, Inc. | 2018-10-03 |
| 2MP Color LCD Monitor CL-R211 (K182539) | Jvckenwood Corporation | 2018-10-03 |
| Harmony (K182376) | Topcon Medical Systems, Inc. | 2018-09-28 |
| Alphenix, INFX-8000F/B, V8.0 (K182415) | Canon Medical Systems Corporation | 2018-09-28 |
| E-CUBE 12 (K181277) | Alpinion Medical Systems Co., Ltd. | 2018-09-28 |
| IBM iConnect Access (K182290) | Merge Healthcare Incorporated | 2018-09-25 |
| Synapse 3D Optional Tools (K181773) | Fujifilm Corporation | 2018-09-25 |
| AMADEO M-DR mini, AMADEO M-AX mini (K182317) | Oehm Und Rehbein GmbH | 2018-09-24 |
| iNtuition-T1 Mapping and T2/T2* Mapping (K180916) | Terarecon,Inc. | 2018-09-24 |
| VeriSuite (K181789) | Medcom GmbH | 2018-09-21 |
| InVivo Web Viewer (K181926) | Anatomage, Inc. | 2018-09-21 |
| Volpara Imaging Software (K182310) | Volpara Health Technologies Limited | 2018-09-21 |
| OpenSight (K172418) | Novarad Corporation | 2018-09-21 |
| LOGIQ P9; LOGIQ P7 (K181783) | GE Healthcare | 2018-09-20 |
| Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A (K182223) | Canon Medical Systems, USA | 2018-09-14 |
| QT Ultrasound Breast Scanner - 1 (K182213) | Qt Ultrasound, LLC | 2018-09-14 |
| DORADOnova MR3T (K173926) | Lap GmbH Laser Applikationen | 2018-09-14 |
| MX40 Mobile Digital X-ray System (K181874) | Huestis Machine Corporation | 2018-09-14 |
| Planmeca Viso (K181576) | Planmeca Oy | 2018-09-13 |
| XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0 (K181415) | Canon Medical Systems Corporation | 2018-09-10 |
| Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask (K182079) | Medtec Inc. Dba Civco Medical Solutions | 2018-09-07 |
| syngo.via View&GO (Version VA10A) (K182208) | Siemens Healthcare GmbH | 2018-09-07 |
| GLOW800 (K181537) | Leica Microsystems (Schweiz) AG | 2018-09-07 |
| CTXX85 (K182147) | Analogic Corporation | 2018-09-07 |
| Multi Modality Viewer (K182230) | Vital Images, Inc. | 2018-09-07 |
| mediCAD 4.0 (K170702) | Medicad Hectec GmbH | 2018-09-07 |
| Ultrasound System SONIMAGE HS1 (K182153) | Konica Minolta, Inc. | 2018-09-06 |
| Optima XR240amx (K182234) | Ge Medical Systems, LLC | 2018-09-06 |
| Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHD (K182138) | Eleckta Limited | 2018-09-05 |
| AmCAD-UT Detection 2.2 (K180006) | Amcad Biomed Corporation | 2018-08-31 |
| Change Healthcare Enterprise Viewer (K181185) | Change Healthcare Canada Company | 2018-08-29 |
| BenQ Diagnostic Ultrasound System (K181313) | Qisda Corporation | 2018-08-27 |
| RadiForce GX560, GX560-AR (K181609) | Eizo Corporation | 2018-08-24 |
| SmartPerfusion (K181966) | Philips Medical Systems Nederlands B.V. | 2018-08-17 |
| CBit Series Digital Color Doppler Ultrasound System (K180974) | CHISON Medical Technologies Co., Ltd. | 2018-08-17 |
| Cios Select (K181767) | Siemens Medical Solutions USA, Inc. | 2018-08-17 |
| PreXion 3D Excelsior (K181983) | Prexion Corporation | 2018-08-17 |
| OSCAR (OSCAR Prime, OSCAR Classic) (K181943) | Genoray Co., Ltd. | 2018-08-17 |
| NeuroQ 3.8 (K180077) | Syntermed | 2018-08-16 |
| IGTFusion (K180522) | Igi Technologies | 2018-08-16 |
| Artis zee/zeego & Artis Q/Q.zen (K181407) | Siemens Medical Solution USA, Inc. | 2018-08-15 |
| Mini Ridge Filter and auxiliary functions for PROBEAT-V (K181676) | Hitachi Ltd. Healthcare Hitachi Works | 2018-08-15 |
| uCT 530, uCT 550 (K181414) | Shanghai United Imaging Healthcare Co., Ltd. | 2018-08-14 |