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1,181 FDA 510(k) clearances · Product code

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RecordFirmDate
ACUSON Redwood Diagnostic Ultrasound System (K243299)Siemens Medical Solutions USA, Inc.2024-11-15
The 5000 Compact Series Ultrasound Systems (K242800)Philips Ultrasound, LLC2024-11-15
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 (K242231)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2024-11-08
Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L) (K241554)Telefield Medical Imaging (Shenzhen) Limited2024-10-24
HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound System (K241971)Samsung Medison Co., Ltd.2024-10-11
EPIQ Series Diagnostic Ultrasound System (K240980)Philips Ultrasound, LLC2024-10-07
Versana Premier; Versana Premier Lotus; LOGIQ F (K242005)GE Medical Systems Ultrasound and Primary Care Diagnostics2024-10-02
SuperSonic HepaVu (K242223)Supersonic Imagine2024-09-20
EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220) (K234153)Edgelife Technologies, LLC2024-09-18
TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite/Anesus TEX20 Pro/Eagus TEX20/Eagus TEX20T/Eagus TEX21/Eagus TEX21T/Eros/TE X Plus/Anesus TEX10 Pro/TEX9U/TEX9M/Eagus TEX11/Eagus TEX11T/EagusTEX10/Eagus TEX10T/Eagus TEX/Ares Diagnostic Ultrasound System (K241201)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2024-09-16
MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System (K241432)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2024-09-12
Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800, TUS-AI700) (K241582)Canon Medical Systems Corporation2024-09-12
FETOLY-HEART (K241380)Diagnoly2024-09-11
Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound Imaging System (LK128C); Ultrasound Imaging System (LK128M); Ultrasound Imaging System (LK128PA); Ultrasound Imaging System (LK128E); Ultrasound Imaging System (LU700C); Ultrasound Imaging System (LU700L); Ultrasound Imaging System (LU710L); Ultrasound Imaging System (LU710LH); Ultrasound Imaging System (LU710C); Ultrasound Imaging System (LU710M); Ultrasound Imaging System (LU710PA); Ultrasound Imaging (K241161)Leltek, Inc.2024-09-11
Vave Wireless Ultrasound System (K241051)Vave Health, Inc.2024-08-30
Kosmos (K233826)EchoNous, Inc.2024-08-29
Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro) (K241979)Beijing Konted Medical Technology Co.,Ltd2024-08-22
SonoMax Series Digital Color Doppler Ultrasound System (K233697)CHISON Medical Technologies Co., Ltd.2024-08-09
TE Air Diagnostic Ultrasound System (K240906)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2024-07-23
ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System, ACUSON Origin ICE Diagnostic Ultrasound System (K240704)Siemens Medical Solutions USA, Inc.2024-07-22
V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System (K240631)Samsung Medison Co., Ltd.2024-06-21
Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus I9, Resona I9W, Recho I9, Recho I9 Pro, Recho I9 Exp, Recho I9S, Recho I9T Diagnostic Ultrasound System (K240684)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2024-06-17
Clarius OB AI (K233955)Clarius Mobile Health Corp.2024-06-14
RS85 Diagnostic Ultrasound System (K240516)Samsung Medison Co., Ltd.2024-06-12
ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound System (K233610)Siemens Medical Solutions USA, Inc.2024-06-12
Venue (K240111)GE Medical Systems Ultrasound and Primary Care Diagnostics2024-06-10
Venue Go (K240053)GE Medical Systems Ultrasound and Primary Care Diagnostics2024-06-10
Venue Sprint (K240206)GE Medical Systems Ultrasound and Primary Care Diagnostics2024-06-10
Venue Fit (K234106)GE Medical Systems Ultrasound and Primary Care Diagnostics2024-06-10
HD80 Series Ultrasound Diagnostic System (K233841)Qingdao Hisense Medical Equipment Co., Ltd.2024-05-16
Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound Diagnostic System (CMS1700C) (K232908)Contec Medical Systems Co.,Ltd2024-05-02
Sonio Detect (K240406)Sonio2024-04-26
EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems (K240850)Philips Ultrasound, LLC2024-04-24
Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY,Resona I8 Easi, Eagus I8 Easi, Nuewa I8W, Nuewa I8, Nuewa I8 Exp, NuewaI8S, Nuewa I8T, Imagyn I8, Imagyn I8S, Imagyn I8T, Imagyn I8 Exp, Nuewa IY Diagnostic Ultrasound System (K240115)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2024-04-22
Digital Ultrasonic Diagnostic Imaging System (Model: F6) (K231930)Guangdong Youkey Medical Co., Ltd.2024-03-22
Voluson Signature 20, Voluson Signature 18 (K233692)GE Medical Systems Ultrasound and Primary Care Diagnostics2024-03-07
HD60 Series Ultrasound Diagnostic System (K233439)Qingdao Hisense Medical Equipment Co., Ltd.2024-02-21
MS55 Plus Digital Color Doppler Ultrasound System (MS55); P25 Expert Digital Color Doppler Ultrasound System (P25 Expert); P12 Plus Digital Color Doppler Ultrasound System (P12 Plus); P11 Plus Portable Digital Color Doppler Ultrasound System (P11 Plus); P9 Plus Ultrasound Diagnostic System (P9 Plus); P3 Plus Ultrasound Diagnostic System (P3 Plus) (K231659)Medisono2024-02-15
EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System (K233788)Philips Ultrasound, LLC2024-02-13
Gem Flow Now (GEM2770-FN) (K233394)Synovis Micro Companies Alliance2024-01-28
Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System (K233195)Canon Medical Systems Corporation2024-01-24
U-Lite PRO (K232285)Sonoscanner Sarl2024-01-11
Butterfly iQ3 Ultrasound System (K232808)Butterfly Network, Inc.2024-01-04
Interson USB Ultrasound System (K233734)Interson Corporation2023-12-22
HM70 EVO Diagnostic Ultrasound System (K233112)Samsung Medison Co., Ltd.2023-12-21
Pocket Ultrasound System (C10) (K231354)Beijing Konted Medical Technology Co.,Ltd2023-12-20
LOGIQ Totus (K232381)GE Medical Systems Ultrasound and Primary Care Diagnostics2023-12-07
Sonosite LX Ultrasound System (K233597)FUJIFILM Sonosite, Inc.2023-12-06
EPIQ Series Diagnostic Ultrasound System (K233545)Philips Ultrasound, LLC2023-11-30
6440 MyLabX90 (K230179)Esaote, S.p.A.2023-11-29
Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound System (K232988)Canon Medical Systems Corporation2023-11-21
ARIETTA x10 (K231941)FUJIFILM Healthcare Americas Corporation2023-11-20
LOGIQ E10s, LOGIQ Fortis (K231989)Ge Medical Systems Ultrasound and Primary Care Diagnostic,2023-11-07
LOGIQ E10 (K231966)GE Medical Systems Ultrasound and Primary Care Diagnostics2023-11-07
LOGIQ e (K232186)Ge Medical Systems Ultrasound and Primary Care Diagnostic,2023-11-03
Voluson Expert 22, Voluson Expert 20, Voluson Expert 18 (K231965)GE Medical Systems Ultrasound and Primary Care Diagnostics2023-10-30
ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System (K232145)Siemens Medical Solutions USA, Inc.2023-10-30
TE Air Diagnostic Ultrasound System (K231685)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2023-10-26
Lumify Diagnostic Ultrasound System (K232500)Philips Ultrasound2023-10-26
Aco Apache Ultrasound System (K231509)Aco Healthcare Co., Ltd.2023-10-24
Ultrasound System 1300 (K231764)Bk Medical Aps2023-10-23
Clarius Ultrasound Scanner (K232704)Clarius Mobile Health Corp.2023-10-05
V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic Ultrasound System (K231772)Samsung Medison Co., Ltd.2023-10-03
ES Series V2 (K232336)E-Scopics2023-09-26
ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound System (K232617)Siemens Medical Solutions USA, Inc.2023-09-26
Carnation series Diagnostic Ultrasound System (K230066)Shenzhen Wisonic Medical Technology Co. , Ltd.2023-09-15
Vscan Air (K231301)GE Medical Systems Ultrasound and Primary Care Diagnostics2023-08-15
Sonio Detect (K230365)Sonio2023-07-25
VINNO G86,VINNO G86E,VINNO G65,VINNO G65P,VINNO G65E,VINNO G65D,VINNO M86, VINNO M86E,VINNO G90,VINNO G90E (K230160)Vinno Technology (Suzhou) Co.,Ltd2023-06-23
Voluson SWIFT; Voluson SWIFT+ (K230346)Ge Medical Systems Ultrasound & Primary Care Diagnostic, LLC2023-06-20
VINNO E20, VINNO E10,VINNO E10P,VINNO E10E, VINNO X1,VINNO X1E,VINNO X1P, VINNO X2,VINNO X2E,VINNO X2P (K223917)Vinno Technology (Suzhou) Co.,Ltd2023-06-17
VINNO G50, VINNO G55, VINNO M50, VINNO E30, VINNO X5, VINNO X6, VINNO X7, VINNO M55, VINNO E35, VINNO X65, VINNO X55, VINNO X35, VINNO G55E, VINNO G55P, VINNO M55E, VINNO M55P, VINNO E35E, VINNO E35P (K223920)Vinno Technology (Suzhou) Co.,Ltd2023-06-17
M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System (K230768)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2023-06-09
EPIQ Series Diagnostic Ultrasound System (K231190)Philips Ultrasound, LLC2023-05-12
Lumify Diagnostic Ultrasound System (K223771)Philips Ultrasound2023-05-04
HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System (K230084)Samsung Medison Co., Ltd.2023-04-21
X-CUBE 50, X-CUBE 60 (K223564)Alpinion Medical Systems Co., Ltd.2023-04-17
Ultrasound System 2300 (K223830)Bk Medical Aps2023-04-11
SonoAir Series Digital Color Doppler Ultrasound System (K223570)CHISON Medical Technologies Co., Ltd.2023-03-31
Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (K223017)Canon Medical Systems Corporation2023-03-31
Vivid S60N, Vivid S70N (K223832)Ge Medical System Ultrasound and Primary Care Diagnostics2023-02-16
Versana Essential (K223407)GE Medical Systems Ultrasound and Primary Care Diagnostics2023-02-15
V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System (K223387)Samsung Medison Co., Ltd.2023-02-13
ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound System (K230207)Siemens Medical Solutions USA, Inc.2023-02-13
S90 Exp Series Digital Color Doppler Ultrasound System (K222596)Sonoscape Medical Corp.2023-02-10
Resona R9/ Resona R9 Exp/ Resona R9 Pro/ Resona R9S/ Nuewa R9/ Nuewa R9 Exp Diagnostic Ultrasound Sysem, Nuewa R9 Pro/ Nuewa R9S/ Resona 7/ Resona 7CV/Resona 7EXP/Resona 7S/ Resona 70B Diagnostic Ultrasound System, Resona 7PRO/Imagyn 7/ Resona Y/Resona R9W/Resona R7W Nuewa R9W/Nuewa R7W Diagnostic Ultrasound System (K222928)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2023-02-07
ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System (K223735)Siemens Medical Solutions USA, Inc.2023-02-06
VINNO 6PRO, VINNO 6EXP, VINNO 5PRO, VINNO 5EXP, VINNO 3, VINNO 3PRO, VINNO 3EXP (K221911)Vinno Technology (Suzhou) Co.,Ltd2022-12-21
Ultrasound System 2300 (K222441)Bk Medical Aps2022-12-07
ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging System (K220983)Imsonic Medical China, Inc.2022-11-11
Exo Iris (El2001) (K222198)Exo Imaging, Inc.2022-11-09
ViewMate Multi Ultrasound System (K222754)Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.2022-11-09
Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC MACH40 (K222191)Supersonic Imagine2022-10-28
Leltek Ultrasound Imaging System (Model: LU700 Series) (K222365)Leltek, Inc.2022-10-25
X-CUBE 70, X-CUBE 90 (K221093)Alpinion Medical Systems Co., Ltd.2022-10-14
X-CUBE 50, X-CUBE 60 (K220857)Alpinion Medical Systems Co., Ltd.2022-10-13
Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL) (K211321)Guangzhou Sonostar Technologies Co., Ltd.2022-10-13
SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SonoFinder Wireless Probe Type Ultrasound Scanner (Model: SF14L25) (K220169)Bionet Co., Ltd.2022-10-11
Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI, Consona NT, Nuewa N9, Recho N9, Consona N9 Exp, Consona N9 Elite, Resona N9, Consona N9T, Consona N8, Consona N8 Pro, Consona N8 Super, Consona OR, Consona N8S, Consona OI, Consona OT, Consona N8 Exp, Consona N8 Elite, Consona N8T, Consona N7, Consona N7 Pro, Consona N7 Super, Consona VR, Consona N7S, Consona VI, Consona VT, Consona N7 Exp, Consona N7 Elite, Consona N7T Diagnostic Ultrasound System (K221300)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2022-09-29
Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S, Consona AE, Consona AT, Consona N6 Exp Diagnostic Ultrasound System, Consona N6 Elite, Consona N6T Diagnostic Ultrasound System (K221496)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2022-09-29
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