| Venue Go (K261668) | GE Medical Systems Ultrasound and Primary care Diagnostics, LLC | 2026-08-07 |
| Alturion Series Diagnostic Ultrasound System (K262311) | Philips Ultrasound, LLC | 2026-08-04 |
| LOGIQ Focus (K261835) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2026-07-30 |
| Handheld Ultrasound Scanner (K261288) | IMGFAX CO., LTD. | 2026-07-30 |
| V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System; V7/XV7/XH7/H7/cV7/V7 ONE/XV7 ONE/H7 ONE/XH7 ONE/cV7 ONE Diagnostic Ultrasound System; V6/XV6/XH6/H6/cV6/V6 ONE/XV6 ONE/H6 ONE/XH6 ONE/cV6 ONE Diagnostic Ultrasound System; V5/XV5/XH5/H5/cV5 Diagnostic Ultrasound System; V4/XV4/XH4/H4/cV4 Diagnostic Ultrasound System; (K261412) | Samsung Medison Co., Ltd. | 2026-07-28 |
| Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic Ultrasound System (K261211) | Philips Ultrasound, LLC | 2026-07-27 |
| Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro) (K261081) | Beijing Konted Medical Technology Co.,Ltd | 2026-07-23 |
| ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/ MOZI-X1/ MOZI-X12/ DF-41E Diagnostic ultrasound system (K261272) | Esonic Technology (Wuhan) Co., Ltd. | 2026-07-23 |
| Alturion Series Diagnostic Ultrasound System (K260667) | Philips Ultrasound, LLC | 2026-06-29 |
| ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound System (K260844) | Siemens Medical Solutions USA, Inc. | 2026-06-16 |
| ES-Series (K260748) | E-Scopics | 2026-06-09 |
| EPIQ Series Diagnostic Ultrasound System (K260123) | Philips Ultrasound, LLC | 2026-05-27 |
| EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems (K260680) | Philips Ultrasound, LLC | 2026-05-27 |
| LOGIQ e (K260398) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2026-05-26 |
| SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp, SonoPort 1 Pro, SonoPort 1 Elite, SonoPort 1 Plus, SonoPort 2, SonoPort 2 Exp, SonoPort 2 Pro, SonoPort 2 Elite, SonoPort 2 Plus, SonoPort 3, SonoPort 3 Exp, SonoPort 3 Pro, SonoPort 3 Elite, SonoPort 3 Plus, SonoPort 4, SonoPort 4 Exp, SonoPort 4 Pro, SonoPort 4 Elite, SonoPort 4 Plus, SonoPort 5, SonoPort 5 Exp, SonoPort 5 Pro, SonoPort 5 Elite, SonoPort 5 Plus, SonoPort 6, SonoPort 6 Exp, SonoPort 6 (K253949) | CHISON Medical Technologies Co., Ltd. | 2026-05-22 |
| uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace, uSONIQUE Grace Elite (K253720) | Wuhan United Imaging Healthcare Co.,Ltd | 2026-05-21 |
| uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE Genesis Super, uSONIQUE Pulse, uSONIQUE Pulse Pro, uSONIQUE Pulse Elite, uSONIQUE Pulse Super, uSONIQUE Venus, uSONIQUE Venus Pro, uSONIQUE Venus Elite, uSONIQUE Venus Super (K253716) | Wuhan United Imaging Healthcare Co.,Ltd | 2026-05-15 |
| Digital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra Senior, Autra CV, e-Autra, Autra 75, Autra 85W, Autra 65, Autra 55, Autra 65i, Autra 90 Elite, Autra 85 Elite, Autra 80 Elite, Autra 75 Elite, Autra 85 CV, Autra 80W, Autra 65 Elite, Autra 55 Elite, Autra 55i, Autra 90 CV, Autra 85, Autra 80, Autra 80 CV, Autra 75 Pro, Autra 75W, Autra 70 Elite, Autra 70, Autra T) (K254028) | Sonoscape Medical Corp. | 2026-05-15 |
| Palmtop Ultrasound Diagnostic System (MT10P/MT10) (K260111) | Mytech Intelligence (Shenzhen) Co., Ltd. | 2026-05-14 |
| Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic Ultrasound System (MU9T);Diagnostic Ultrasound System (MU9 Exp);Diagnostic Ultrasound System (MU9 Pro);Diagnostic Ultrasound System (MU9 Super);Diagnostic Ultrasound System (MU9P);Diagnostic Ultrasound System (MU9A);Diagnostic Ultrasound System (MU7);Diagnostic Ultrasound System (MU7S);Diagnostic Ultrasound System (MU7T);Diagnostic Ultrasound System (MU7 Exp);Diagnostic Ultrasound System (MU7 Pro);Diagnos (K260846) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2026-05-11 |
| Healium Intelliscan LX192LC (K261132) | Healium Intelliscan Corporation | 2026-05-05 |
| Lumify Diagnostic Ultrasound System (K252558) | Philips Ultrasound, LLC | 2026-05-05 |
| ES-Series (K260589) | E-Scopics | 2026-04-29 |
| 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) (K253288) | Esaote, S.p.A. | 2026-04-06 |
| Wireless Probe Type Ultrasound Scanner (K252709) | Xuzhou Yongkang Electronic Science Technology Co., Ltd. | 2026-04-02 |
| EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System (K253595) | Philips Ultrasound, LLC | 2026-03-27 |
| EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10 Diagnostic Ultrasound System; EVO XQ30 Diagnostic Ultrasound System; EVO XQ20 Diagnostic Ultrasound System; EVO XQ10 Diagnostic Ultrasound System; EVO QH30 Diagnostic Ultrasound System; EVO QH20 Diagnostic Ultrasound System; EVO QH10 Diagnostic Ultrasound System (K254099) | Samsung Medison Co., Ltd. | 2026-03-27 |
| Butterfly Gestational Age Tool (K252148) | Butterfly Network, Inc. | 2026-03-27 |
| LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 Power (K260673) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2026-03-24 |
| Sonio Detect (v3) (K252433) | Sonio | 2026-03-16 |
| Sonosite iLOOK Ultrasound System (K260595) | FUJIFILM Sonosite, Inc. | 2026-03-10 |
| Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System (K253049) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2026-02-11 |
| Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System (K253597) | Canon Medical Systems Corporation | 2026-01-20 |
| LOGIQ Totus (K253370) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2026-01-08 |
| LOGIQ Fortis (K253366) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2026-01-07 |
| HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound System (K252018) | Samsung Medison Co., Ltd. | 2026-01-05 |
| Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP) (K251268) | Edan Instruments, Inc. | 2025-12-23 |
| Lumify Diagnostic Ultrasound System (K252557) | Philips Ultrasound, LLC | 2025-12-22 |
| BioticsAI (K250959) | Bioticsai, Inc. | 2025-12-22 |
| Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11 Super/X11 Senior/X11/E11/E11 Pro/E11 Plus/E11 Elite/X11T/X11U/X11R/X11i/X11s/E11T/E11i/E11s/XR1/XR2/ XR3/ER1/ER2/ER3/X10 Exp/X10 Elite/X10 Pro/X10 Plus/X10 Super/X10 Senior/X10/X10T/X10U/ X10R/X10i/X10s/E10/E10 Pro/E10 Plus/E10T/E10i/E10s/SU11A EXP/SU11A PRO/SU11A AD/ SU11A CU/SU11B EXP/SU11B PRO/SU11B AD/SU11B CU/SU11C EXP/SU11C PRO/SU11C AD/ SU11C CU) (K252498) | Sonoscape Medical Corp. | 2025-12-05 |
| ASUS Ultrasound Imaging System (LU800 series) (K250791) | Asustek Computer, Inc. | 2025-12-04 |
| Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous 6/Fibrous 5 Diagnostic UltrasoundSystem (K251601) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025-12-03 |
| 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30) (K253310) | Esaote, S.p.A. | 2025-11-25 |
| Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 (K252328) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2025-11-24 |
| ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound System (K253487) | Siemens Medical Solutions USA, Inc. | 2025-11-17 |
| ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound System (K253457) | Siemens Medical Solutions USA, Inc. | 2025-11-13 |
| Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S, Consona EI, Consona EF, Consona N5 Elite, Consona N5 Ultra, Consona N3, Consona N3 Exp Diagnostic Ultrasound System (K251853) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025-11-07 |
| Sonosite MT Ultrasound System (K253448) | FUJIFILM Sonosite, Inc. | 2025-11-03 |
| Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System (K252074) | Canon Medical Systems Corporation | 2025-10-31 |
| LOGIQ E10s (K251963) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2025-10-29 |
| LOGIQ E10 (K251985) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2025-10-29 |
| EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System (K251651) | Philips Ultrasound, LLC | 2025-10-09 |
| Shear Wave Quantificational Ultrasound Diagnostic System (FH9000/FH7000/FH6000/FH5000/FH3000/FH1000) (K250026) | Wuxi Hisky Medical Technologies Co., Ltd. | 2025-10-01 |
| ViewMateTM Ultrasound System (K251820) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025-09-12 |
| FETOLY (K251368) | Diagnoly | 2025-09-12 |
| ViewMate™ Multi Ultrasound System (VMM-ICE-01); ViewMate™ Multi Ultrasound System (VMM-ICE-02) (K251250) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025-09-05 |
| Sonosite LX and Sonosite PX Ultrasound Systems (K251106) | FUJIFILM Sonosite, Inc. | 2025-08-29 |
| Diagnostic Ultrasound System (MX7); Diagnostic Ultrasound System (MX7T); Diagnostic Ultrasound System (Vaus7); Diagnostic Ultrasound System (Zeus); Diagnostic Ultrasound System (ME7); Diagnostic Ultrasound System (Anesus ME7); Diagnostic Ultrasound System (Anesus ME7T); Diagnostic Ultrasound System (MX7P); Diagnostic Ultrasound System (MX7W); Diagnostic Ultrasound System (MX8); Diagnostic Ultrasound System (MX8T); Diagnostic Ultrasound System (Vaus8); Diagnostic Ultrasound System (ME8) (K251192) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025-08-22 |
| ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound System (K251481) | Siemens Medical Solutions USA, Inc. | 2025-08-20 |
| Venue; Venue Go; Venue Fit; Venue Sprint (K251322) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2025-07-25 |
| EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System (K251455) | Philips Ultrasound, LLC | 2025-07-24 |
| V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System; V5 Diagnostic Ultrasound System; cV5 Diagnostic Ultrasound System; V4 Diagnostic Ultrasound System; cV4 Diagnostic Ultrasound System (K250999) | Samsung Medison Co., Ltd. | 2025-07-18 |
| Vivid Pioneer (K251169) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2025-07-10 |
| Sonosite LX Ultrasound System (K251830) | FUJIFILM Sonosite, Inc. | 2025-07-10 |
| 6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70) (K243253) | Esaote, S.p.A. | 2025-06-18 |
| EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems (K250886) | Philips Ultrasound, LLC | 2025-06-18 |
| TE Air Diagnostic Ultrasound System (K250024) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025-05-30 |
| Voluson™ Performance 16; Voluson™ Performance 18 (K250543) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2025-05-29 |
| DEEPECHO (K242594) | Deepecho | 2025-05-23 |
| EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System (K243793) | Philips Ultrasound, LLC | 2025-05-21 |
| Diagnostic Ultrasound System (Recho R9W); Diagnostic Ultrasound System (Recho R9); Diagnostic Ultrasound System (Recho R9 Pro); Diagnostic Ultrasound System (Recho R9 Exp); Diagnostic Ultrasound System (Recho R9S); Diagnostic Ultrasound System (Recho R9T); Diagnostic Ultrasound System (Crius R9 CV); Diagnostic Ultrasound System (Anesus R9 CV); Diagnostic Ultrasound System (Recho R9 Super); Diagnostic Ultrasound System (Recho R9 Lumi); Diagnostic Ultrasound System (Recho R CV); Diagnost (K250020) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025-05-19 |
| 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) (K241671) | Esaote, S.p.A. | 2025-05-16 |
| Diagnostic Ultrasound System (MX6); Diagnostic Ultrasound System (MX6S); Diagnostic Ultrasound System (MX6T); Diagnostic Ultrasound System (MX6 Exp); Diagnostic Ultrasound System (MX6 Pro); Diagnostic Ultrasound System (MX6 Super); Diagnostic Ultrasound System (MXG); Diagnostic Ultrasound System (Emerus MX6); Diagnostic Ultrasound System (Emerus MX6 Exp); Diagnostic Ultrasound System (Anesus MX6); Diagnostic Ultrasound System (Anesus MX6 Exp); Diagnostic Ultrasound System (Crius MX6); (K250110) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025-05-16 |
| Lumify Diagnostic Ultrasound System (K242519) | Philips Ultrasound | 2025-05-15 |
| Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5 (K242808) | Canon Medical Systems Corporation | 2025-05-13 |
| EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems (K251110) | Philips Ultrasound, LLC | 2025-05-09 |
| Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series); Ultrasound Imaging System (LX Series) (K243226) | Leltek, Inc. | 2025-05-08 |
| Lumify Diagnostic Ultrasound System (K242670) | Philips Ultrasound | 2025-05-08 |
| Vscan Air (K250087) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2025-05-01 |
| Flash Ultrasound System 5100 Point of Care (K250030) | Philips Ultrasound, LLC | 2025-04-28 |
| Kosmos (K242321) | EchoNous, Inc. | 2025-04-25 |
| eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R, eHertz S) (K250228) | Esonic Technology (Wuhan) Co., Ltd. | 2025-04-23 |
| EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System (K250177) | Philips Ultrasound, LLC | 2025-04-10 |
| Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound System (K243298) | Carbon (Shenzhen) Medical Device Co., Ltd. | 2025-04-03 |
| Digital Color Doppler Ultrasound Imaging System (Apogee C1); Digital Color Doppler Ultrasound Imaging System (Apogee C2); Digital Color Doppler Ultrasound Imaging System (Apogee C3); Digital Color Doppler Ultrasound Imaging System (Apogee C5); Digital Color Doppler Ultrasound Imaging System (Apogee K1); Digital Color Doppler Ultrasound Imaging System (Apogee K2); Digital Color Doppler Ultrasound Imaging System (Apogee K3); Digital Color Doppler Ultrasound Imaging System (Apogee K5); Di (K243178) | Shantou Institute of Ultrasonic Instruments Co., Ltd. | 2025-03-31 |
| Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8, Acclarix AX75, Acclarix AX78, Acclarix AX8 Exp, Acclarix AX8 Super), Acclarix AX9 Series Diagnostic Ultrasound Szystem (Model: Acclarix AX9 Basic, Acclarix AX9, Acclarix AX9 Exp, Acclarix AX9 Super, Acclarix AX85, Acclarix AX88) (K250214) | Edan Instruments, Inc. | 2025-02-20 |
| NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUSONO Handheld Ultrasound Scanner (NUSONO-L75); NUSONO Handheld Ultrasound Scanner (NUSONO-P25) (K242681) | Nurodata, Inc. | 2025-02-20 |
| V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System (K243702) | Samsung Medison Co., Ltd. | 2025-02-12 |
| Vivid iq (K243620) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2025-02-11 |
| Vivid T9/Vivid T8 (K243628) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2025-02-11 |
| EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System (K243794) | Philips Ultrasound, LLC | 2025-02-06 |
| Digital Color Doppler Ultrasound System (P60 Series) (K241949) | Sonoscape Medical Corp. | 2025-01-17 |
| EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME3 (OLYMPUS EU-ME3) (K243502) | Olympus Medical Systems Corporation | 2025-01-17 |
| Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 (K242168) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2024-12-20 |
| ULTIMUS Series Ultrasound Diagnostic System (K240676) | Vinno Technology (Suzhou) Co.,Ltd | 2024-12-16 |
| EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System (K242020) | Philips Ultrasound, LLC | 2024-12-12 |
| Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler Ultrasound Imaging System (Readius P8); Digital Color Doppler Ultrasound Imaging System (Readius V6); Digital Color Doppler Ultrasound Imaging System (Readius C6) (K243132) | Shantou Institute of Ultrasonic Instruments Co., Ltd. | 2024-12-10 |
| V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic Ultrasound System, XH5 Diagnostic Ultrasound System, V4 Diagnostic Ultrasound System, H4 Diagnostic Ultrasound System, XV4 Diagnostic Ultrasound System, XH4 Diagnostic Ultrasound System (K242511) | Samsung Medison Co., Ltd. | 2024-12-10 |
| HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System (K242444) | Samsung Medison Co., Ltd. | 2024-11-27 |
| ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound System (K242523) | Siemens Medical Solutions USA, Inc. | 2024-11-19 |