| syngo Application Software (K190780) | Siemens Medical Solution USA, Inc. | 2019-09-12 |
| uDR 592h, uDR 596i (K192293) | Shanghai United Imaging Healthcare Co., Ltd. | 2019-09-12 |
| ARTIS icono (K190768) | Siemens Medical Solutions USA, Inc. | 2019-09-12 |
| CRC PC Smart Chamber K1 (K192199) | Capintec, Inc. | 2019-09-12 |
| AI-Rad Companion (Cardiovascular) (K183268) | Siemens Medical Solutions USA, Inc. | 2019-09-10 |
| Encompass 15 Channel Head Coil, 3T (K190668) | Qfix | 2019-09-09 |
| Lumify Diagnostic Ultrasound System (K192226) | Philips Health Care | 2019-09-06 |
| EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F (K183525) | Olympus Medical Systems Corp. | 2019-09-06 |
| Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive Workflow Tools (IWT) (K191845) | Barco N.V. | 2019-09-06 |
| Aquilion ONE (TSX-306A/3) V10.0 (K192188) | Canon Medical Systems Corporation | 2019-09-06 |
| MobileRay Pulse SE Digital Imaging System (K191503) | Portavision Medical, LLC | 2019-09-04 |
| Akesis Galaxy (K190844) | Akesis, Inc. | 2019-09-04 |
| T1-CS, T1-C (K183475) | Osstem Implant Co., Ltd. | 2019-08-30 |
| D2P (K183489) | 3D Systems, Inc. | 2019-08-29 |
| Clarius Ultrasound Scanner (K192107) | Clarius Mobile Health Corp. | 2019-08-29 |
| Yushan X-Ray Flat Panel Detector (K191939) | Innocare Optoelectronics Corp. | 2019-08-29 |
| Voluson E6, Voluson E8, Voluson E10 (K192159) | GE Healthcare | 2019-08-29 |
| Efficient Care 3D Planning (K183544) | Orthosoft Inc (D/B/A Zimmer Cas) | 2019-08-23 |
| ARCO FP (K182086) | A.T.S. Applicazione Tecnologie Speciali S.R.L. | 2019-08-20 |
| SKR 4000 (K191645) | Konica Minolta, Inc. | 2019-08-16 |
| PowerDR (K191504) | Radiology Information Systems, Inc. | 2019-08-16 |
| ACUSON P200 Diagnostic Ultrasound System (K191922) | Siemens Medical Solutions USA, Inc. | 2019-08-15 |
| Cartesion Prime (K191582) | Canon Medical Systems Corporation | 2019-08-13 |
| Critical Care Suite (K183182) | Ge Medical Systems, LLC | 2019-08-12 |
| Versana Balance (K191792) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2019-08-09 |
| Versana Active (K191798) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2019-08-09 |
| DR 100s (K191884) | Agfa N.V. | 2019-08-09 |
| ARIETTA 750 (K191233) | Hitachi Healthcare Americas | 2019-08-09 |
| ILLUMISITE Platform (K191394) | Covidien, LLC | 2019-08-07 |
| exoplan 2.3 (K183458) | Exocad GmbH | 2019-08-06 |
| The AIO Solution (K191158) | Orfit Industries NV | 2019-08-06 |
| aBSI (K191262) | Exini Diagnostics AB | 2019-08-05 |
| FLUOROspeed (K191877) | Shimadzu Corporation | 2019-08-05 |
| MobileDiagnost wDR 2.2 (K191813) | Sedecal., Sa. | 2019-08-02 |
| MREplus+ Software (K183193) | Resoundant, Inc. | 2019-08-01 |
| ImagingRing System on Rails (K191267) | Medphoton GmbH | 2019-08-01 |
| Mobius3D (K191761) | Varian Medical Systems, Inc. | 2019-07-31 |
| Access CT (K191136) | Philips Healthcare (Suzhou) Co., Ltd. | 2019-07-29 |
| Sample Imaging for Senographe Pristina (K190809) | GE Healthcare | 2019-07-29 |
| BiomarC Fiducial Marker (K191797) | Carbon Medical Technologies | 2019-07-29 |
| Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition (K191777) | Ge Medical Systems, LLC | 2019-07-26 |
| AI-Rad Companion (Pulmonary) (K183271) | Siemens Medical Solutions USA, Inc. | 2019-07-26 |
| Discovery XR656 HD with VolumeRad (K191699) | Ge Hualun Medical Systems Co. , Ltd. | 2019-07-24 |
| Vantage Orian 1.5T, MRT-1550, V4.5 (K191662) | Canon Medical Systems Corporation | 2019-07-23 |
| SpaceOAR Vue Hydrogel (K182971) | Augmenix, Inc. | 2019-07-19 |
| NvisionVLE Low-profile Optical Probe (K191117) | Ninepoint Medical, Inc. | 2019-07-19 |
| syngo.via MI Workflows VB40A, Scenium (K191309) | Siemens Medical Soultions USA, Inc. | 2019-07-19 |
| Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0 (K191467) | Canon Medical Systems Corporation | 2019-07-19 |
| Huvitz Imaging System (K191615) | Huvitz Co., Ltd. | 2019-07-18 |
| Orthophos S (K191616) | Dentsply Sirona | 2019-07-16 |
| VERITON CT whole body SPECT/CT system (K190457) | Spectrum Dynamics Medical, Ltd. | 2019-07-12 |
| iNtuition-Structural Heart Module (K191585) | Terarecon,Inc. | 2019-07-12 |
| MAGNETOM Aera and MAGNETOM Skyra with Software syngo MR E11E with Ischemic Heart Disease (IHD) Workflow (K191050) | Siemens Medical Solutions USA, Inc. | 2019-07-12 |
| Unifi Workspace v1.0.0 (K190694) | Hologic, Inc. | 2019-07-11 |
| Full Digital Colour Doppler Ultrasonic Diagnostic System (K183041) | Wuhan Zoncare Bio-medical Electronics Co., Ltd. | 2019-07-10 |
| DeepCT (K182875) | Deep01 Limited | 2019-07-10 |
| Identify (K190137) | Varian Medical Systems, Inc. | 2019-07-10 |
| Vave Personal Ultrasound System (K191541) | Vave Health, Inc. | 2019-07-10 |
| nView system 1 (K190064) | Nview Medical, Inc. | 2019-07-08 |
| BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment Device (K191580) | Varian Medical Systems, Inc. | 2019-07-08 |
| RayCare 2.3 (K191384) | RaySearch Laboratories AB (PUBL) | 2019-07-08 |
| syngo.MR Applications (K182904) | Siemens Medical Solutions USA, Inc. | 2019-07-05 |
| Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE (K182901) | Canon Medical Systems Corporation | 2019-07-05 |
| CMDR 2CW (Multiple models) (K191451) | Minxray, Inc. | 2019-07-03 |
| Koios DS for Breast (K190442) | Koios Medical, Inc. | 2019-07-03 |
| syngo.CT Dual Energy (K191468) | Siemens Medical Solutions USA, Inc. | 2019-07-03 |
| Biopsy Positioner (K191495) | Fujifilm Corporation | 2019-07-03 |
| 5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500 (K191137) | Jvckenwood Corporation | 2019-07-02 |
| MRopen 0.5 T (K190524) | Asg Superconductors S.P.A. | 2019-07-01 |
| LIGHTMED Ultrasound System (K183173) | Lightmed USA, Inc. | 2019-07-01 |
| Z-Robot Patient Positioning System (K182683) | Chinan Biomedical Technology, Inc. | 2019-06-27 |
| SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Edge Plus, SOMATOM Definition AS/AS+, SOMATOM Confidence (K190578) | Siemens Medical Solutions USA, Inc. | 2019-06-27 |
| LiverMultiScan (LMSv3) (K190017) | Perspectum Diagnostics, Ltd. | 2019-06-27 |
| Vantage Titan 3T, MRT-3010, V2.5 (K191128) | Canon Medical Systems Corporation | 2019-06-26 |
| R2GATE (K190096) | Megagen Implant Co., Ltd. | 2019-06-26 |
| uWS-CT (K183170) | Shanghai United Imaging Healthcare Co., Ltd. | 2019-06-24 |
| OrthoScan TAU Mini C-Arm (K183220) | Orthoscan, Inc. | 2019-06-21 |
| Kubtec Mozart (Xpert42) (K183624) | Kub Technologies, Inc. | 2019-06-20 |
| Multix Fusion Max (K191418) | Siemens Medical Solutions USA, Inc. | 2019-06-19 |
| RayStation (K190387) | RaySearch Laboratories AB (PUBL) | 2019-06-19 |
| QLAB Advanced Quantification Software 13 (K190913) | Philips Health Care | 2019-06-18 |
| Transcranial Doppler Ultrasound System (K190228) | Shenzhen Delica Medical Equipment Co., Ltd. | 2019-06-13 |
| HealthICH (K190424) | Zebra Medical Vision, Ltd. | 2019-06-13 |
| ClariCT.AI (K183460) | Claripi, Inc. | 2019-06-13 |
| SyMRI (K191036) | Syntheticmr AB | 2019-06-13 |
| Aquilion ONE (TSX-305A/6) V8.9 with AiCE (K183046) | Canon Medical Systems Corporation | 2019-06-12 |
| RS85 Diagnostic Ultrasound System (K191115) | Samsung Medison Co., Ltd. | 2019-06-12 |
| HS40 Diagnostic Ultrasound System (K191055) | Samsung Medison Co., Ltd. | 2019-06-12 |
| Insight Essentials DRF Digital Imaging System (K191310) | Imaging Engineering, LLC | 2019-06-10 |
| 7410 Ultrasound System (MyLabSigma) (K191072) | Esaote, S.p.A. | 2019-06-10 |
| Low Dose Lung Screening Option (K190505) | Canon Medical Systems Corporation | 2019-06-05 |
| Palm Bladder Scanner - PBSV5.1 (K191307) | Mianyang Meike Electronic Equipment Co., Ltd. | 2019-06-05 |
| Materialise Mimics Enlight (K190874) | Materialise NV | 2019-06-05 |
| Achieva 1.5T, 3.0T and Intera 1.5T MR Systems (K190461) | Philips Medical Systems Nederland B.V. | 2019-06-04 |
| BriefCase (K190896) | Aidoc Medical , Ltd. | 2019-05-31 |
| MAGNETOM Avanto Fit (K190757) | Siemens Medical Solution USA, Inc. | 2019-05-31 |
| ASHK100G (K191188) | Lg Electronics | 2019-05-30 |
| Qangio XA 3D (K182611) | Medis Medical Imaging Systems BV | 2019-05-30 |
| uMR 780, uMR 790 (K191157) | Shanghai United Imaging Healthcare Co., Ltd. | 2019-05-29 |
| Brain Perfusion (BP) application (K182716) | Philips Medical Systems Nederland B.V. | 2019-05-29 |