| Accuro 3S (K253452) | Rivanna Medical, Inc. | 2026-07-24 |
| ARTHUR (K260190) | ROPCA ApS | 2026-06-18 |
| EdgeFlow UW20 (K252237) | Edgecare, Inc. | 2026-04-17 |
| Accuro XV (K254021) | Rivanna Medical, Inc. | 2026-04-09 |
| QT Scanner 2000 Model A (K253898) | QT Imaging Holdings, Inc. | 2026-03-04 |
| IntraSight Plus (K253714) | Philips Image Guided Therapy Corporation | 2026-02-24 |
| Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro) (K253221) | Eieling Technology (Shenzhen) Limited | 2026-02-06 |
| Astrasono A3Pro Bladder Scanner (A3Pro) (K250331) | Astrasono Technology Co., Ltd. | 2025-09-30 |
| Deepsight NeedleVue LC1 Ultrasound System (K250381) | DeepSight Technology, Inc. | 2025-08-01 |
| B-Scan (K243227) | Accutome, Inc. Doing Business AS Keeler USA | 2025-07-11 |
| Velacur One (LI-1100) (K251728) | Sonic Incytes Medical Corp | 2025-06-26 |
| Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100) (K243880) | Wuxi Hisky Medical Technologies Co., Ltd. | 2025-06-17 |
| Accuro 3S (K243937) | Rivanna Medical, Inc. | 2025-05-23 |
| EchoGuide (Version 1) (K243479) | Sonavex, Inc. | 2025-04-23 |
| Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C) (K242496) | Eieling Technology (Shenzhen) Limited | 2024-11-19 |
| SpineUs™ System (K241029) | Verdure Imaging | 2024-10-07 |
| Velacur (K233977) | Sonic Incytes | 2024-09-04 |
| SC1 Handheld Ultrasound Imaging system (Model: SC1) (K233579) | Fcu Co., Ltd. | 2024-06-26 |
| ACUSON SC2000 Diagnostic Ultrasound System (K233613) | Siemens Medical Solutions USA, Inc. | 2024-06-12 |
| B-Ultrasound Diagnostic System (K232895) | Contec Medical Systems Co.,Ltd | 2024-05-03 |
| Pocket III (K232302) | Quantel Medical | 2024-04-26 |
| EdgeFlow UH10 (K231677) | Edgecare, Inc. | 2024-03-06 |
| BD Prevue™ II Peripheral Vascular Access System (K240146) | Bard Access Systems, Inc. | 2024-02-18 |
| Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile) (K233401) | Eieling Technology Limited | 2024-02-12 |
| Bladder Scanner (K230986) | Avantsonic Technology Co., Ltd. | 2023-12-29 |
| Endoscopic Ultrasonic Diagnostic Equipment /Disposable Sterile Endoscopic Ultrasonic Probe (USW-S1,USW140-S20MS) (K231889) | Ultrasound Biotechnology (Shanghai) Co., Ltd. | 2023-12-21 |
| iSR`obot Mona Lisa 2.0 (K232320) | Biobot Surgical Pte., Ltd. | 2023-12-21 |
| K3900 Ultrasound Imaging System (K230511) | Maui Imaging | 2023-10-25 |
| Velacur (K232459) | Sonic Incytes | 2023-09-12 |
| SiteRite™ 9 Ultrasound System (K231283) | Bard Access Systems, Inc. (C.R. Bard, Inc.) | 2023-09-11 |
| Bladder Scanner Model: BVT02 (K223448) | Xuzhou Kaixin Electronic Instrument Co., Ltd. | 2023-07-07 |
| Velacur (K223287) | Sonic Incytes | 2023-04-20 |
| Butterfly iQ/iQ+ Ultrasound System (K220068) | Butterfly Network, Inc. | 2023-03-31 |
| FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630) (K223902) | Echosens | 2023-03-02 |
| Sunkingdom Ophthalmic Ultrasound Examination Instrument SK-3000A, SK-3000B, SK-3000C, SK-2000AP, SK-2000A, SK-2000P (K222787) | Chongqing Sunkingdom Medical Instrument Co., Ltd. | 2023-01-09 |
| QT Scanner 2000 Model A (K220933) | Qt Imaging, Inc. | 2022-08-31 |
| Bladder Scanner, Model Name:M5 (K213488) | Suzhou Peaksonic Medical Technology Co., Ltd. | 2022-07-01 |
| NAVIRFA Scope (K211529) | Navifus Corporation | 2022-05-05 |
| ATUSA™ Automated 3D Breast Ultrasound System (K213620) | Isono Health, Inc. | 2022-04-22 |
| EchoSK and EchoSGyn modules for EchoS Family devices (K212851) | Echolight S.P.A | 2022-03-16 |
| iSR’obot Mona Lisa 2.0 (K213411) | Biobot Surgical Pte., Ltd. | 2021-12-22 |
| Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro IVUS + NIRS Imaging Catheter ,TVC-C195-42, Peripheral 014 Imaging Catheter, TVC-E195-42 (K213303) | Infraredx, Inc. | 2021-12-07 |
| MD-320W Ultrasound Biomicroscope (K213070) | MEDA Co., Ltd. | 2021-11-18 |
| Axialis Ophthalmic Ultrasound System (K213254) | Quantel Medical | 2021-11-15 |
| Acuson SC2000 Diagnostic Ultrasound System (K211726) | Siemens Medical Solutions USA, Inc. | 2021-11-05 |
| FibroScan 230 (K212035) | Echosens | 2021-07-30 |
| SC1 Handheld Ultrasound Imaging System (Model: SC1) (K210468) | Fcu Co., Ltd. | 2021-07-23 |
| iSR'obot Mona Lisa 1.0 (K203659) | Biobot Surgical Pte., Ltd. | 2021-07-08 |
| BD Prevue II Peripheral Vascular Vascular Access System (K211193) | Bard Access Systems, Inc. (C.R. Bard, Inc.) | 2021-06-25 |
| THD Procto Software System (K211623) | Thd Spa | 2021-06-24 |
| Palm Bladder Scanner - PBSV7.1 (K210591) | Mianyang Meike Electronic Equipment Co., Ltd. | 2021-06-09 |
| Breast Volume Navigator (BVN) Model G-2000 (K211098) | Metritrack, Inc. | 2021-05-26 |
| FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630) (K203273) | Echosens | 2021-03-25 |
| Bladder Scanner (Model: M3, M3-HD, M4, M4-HD) (K201316) | Suzhou Peaksonic Medical Technology Co., Ltd. | 2021-02-26 |
| IntraSight Mobile (K203719) | Volcano Corporation | 2021-01-19 |
| AcuSee AS-P1000 System (K202119) | Weipeng (Suzhou) Medical Devices Co., Ltd. | 2020-10-07 |
| CUBEScan BioCon-1100 (K201995) | Mcube Technology Co., Ltd. | 2020-08-19 |
| Liver Incytes, Model 1005 (K201597) | Sonic Incytes | 2020-07-31 |
| FibroScan® 630 (K200655) | Echosens | 2020-07-16 |
| Auto 3D Bladder Volume Tool (K200980) | Butterfly Network, Inc. | 2020-06-11 |
| CUBEScan BioCon-900S (K200749) | Mcube Technology Co., Ltd. | 2020-05-19 |
| CUBEScan BioCon-1100 (K200548) | Mcube Technology Co., Ltd. | 2020-03-27 |
| Shear Wave Quantificational Ultrasound Diagnostic System (K200136) | Wuxi Hisky Medical Technologies Co., Ltd. | 2020-03-17 |
| SonicEye Dual-Array Ultrasound System (K192253) | Sonivate Medical, Inc. | 2020-02-25 |
| THD Procto Software System (K193512) | Thd Spa | 2020-01-26 |
| VistaScan USB Ultrasound Imaging System (K192170) | Emagine Solutions Technology, LLC | 2020-01-23 |
| Diagnostic Ultrasound System (K192791) | Edan Instruments, Inc. | 2019-11-27 |
| Dolphin Medical Imaging USB Ultrasound System (K192573) | Dolphin Medical Imaging, LLC | 2019-11-19 |
| QT Scanner 2000 Model A (K190646) | Qt Ultrasound, LLC | 2019-10-18 |
| Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000 (K190314) | Mednovel Technology, Ltd. | 2019-10-09 |
| Vave Personal Ultrasound System (K191541) | Vave Health, Inc. | 2019-07-10 |
| LIGHTMED Ultrasound System (K183173) | Lightmed USA, Inc. | 2019-07-01 |
| Palm Bladder Scanner - PBSV5.1 (K191307) | Mianyang Meike Electronic Equipment Co., Ltd. | 2019-06-05 |
| Bladder Scanner (Models: M2, M2-W, M1, M1-W) (K190769) | Suzhou Lischka Medtech Co., Ltd. | 2019-05-22 |
| MD-6000P Bladder Scanner (K182460) | MEDA Co., Ltd. | 2019-05-06 |
| Eye Prime (K190786) | Ellex Medical Pty, Ltd. | 2019-04-11 |
| Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound System (K190186) | Edan Instruments, Inc. | 2019-03-28 |
| ABSOLU (K183414) | Quantel Medical | 2019-03-20 |
| EchoSure Diagnostic Ultrasound System (K190039) | Sonavex, Inc. | 2019-03-08 |
| Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech (K182281) | C. R. Bard | 2018-10-24 |
| QT Ultrasound Breast Scanner - 1 (K182213) | Qt Ultrasound, LLC | 2018-09-14 |
| Ultrasound System SONIMAGE HS1 (K182153) | Konica Minolta, Inc. | 2018-09-06 |
| Uscan (K181574) | EchoNous, Inc. | 2018-07-10 |
| FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) (K181547) | Echosens | 2018-07-09 |
| Shear Wave Quantificational Ultrasound Diagnostic System (K173595) | Wuxi Hisky Medical Technologies Co., Ltd. | 2018-06-22 |
| ExactVu High Resolution Micro-Ultrasound System (K180636) | Exact Imaging, Inc. | 2018-04-30 |
| LIGHTSonic BUBM (K170761) | Lightmed USA, Inc. | 2018-04-13 |
| s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound Imaging and Pressure Systems, CORE Precision Guided Therapy System, CORE Mobile Precision Guided Therapy System (K173860) | Volcano Corporation | 2018-04-11 |
| SoftVue (K172256) | Delphinus Medical Technologies | 2018-03-02 |
| COMPACT TOUCH Ophthalmic Ultrasound System (K180265) | Quantel Medical | 2018-03-02 |
| Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe) (K172750) | Guangzhou Sonostar Technologies Co., Ltd. | 2018-02-28 |
| Ultrasound System SONIMAGE MX1 (K180084) | Konica Minolta, Inc. | 2018-02-08 |
| Bladder Scanner (model: PadScan DS3, PadScan Z3, PadScan Z5) (K171528) | Avantsonic Technology Co., Ltd. | 2018-01-24 |
| InnoSight Diagnostic Ultrasound System (K172056) | Qisda Corporation | 2017-12-13 |
| Lilium a-200E (K170046) | Lilium Otsuka Co., Ltd. | 2017-12-07 |
| DUS-6000 Digital Ultrasonic Diagnostic Imaging System (K172931) | Advanced Instrumentations, Inc. | 2017-12-01 |
| CMS600P2 B-Ultrasound Diagnostic System (K170856) | Contec Medical Systems Co.,Ltd | 2017-11-17 |
| FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) (K173034) | Echosens | 2017-11-14 |
| Biim Diagnostic Ultrasound System (K173138) | Biim Ultrasound AS | 2017-10-27 |
| CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2 Installation Kit (K172455) | Volcano Corporation | 2017-10-25 |