K260111
Mytech Intelligence (Shenzhen) Co., Ltd.
Palmtop Ultrasound Diagnostic System (MT10P/MT10)
II
2026-05-14
K252653
Acist Medical Systems, Inc.
ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer Cable
II
2026-05-13
K260846
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
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
II
2026-05-11
K252558
Philips Ultrasound, LLC
Lumify Diagnostic Ultrasound System
II
2026-05-05
K254099
Samsung Medison Co., Ltd.
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
II
2026-03-27
K253595
Philips Ultrasound, LLC
EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System
II
2026-03-27
K253049
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
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
II
2026-02-11
K252909
Ningbo Runyes Medical Instrument Co., Ltd.
Diagnostic X-Ray Equipment Model POCT22
II
2026-02-03
K253597
Canon Medical Systems Corporation
Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System
II
2026-01-20
K252794
Imricor Medical Systems, Inc.
Vision-MR Diagnostic Catheter
II
2026-01-08
K252018
Samsung Medison Co., Ltd.
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
II
2026-01-05
K251268
Edan Instruments, Inc.
Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)
II
2025-12-23
K252557
Philips Ultrasound, LLC
Lumify Diagnostic Ultrasound System
II
2025-12-22
K251601
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
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
II
2025-12-03
K252405
Surgical Instrument Service and Savings, Inc.
Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheter
II
2025-11-26
K253487
Siemens Medical Solutions USA, Inc.
ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound System
II
2025-11-17
K253457
Siemens Medical Solutions USA, Inc.
ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound System
II
2025-11-13
K251853
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
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
II
2025-11-07
K252074
Canon Medical Systems Corporation
Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System
II
2025-10-31
K251651
Philips Ultrasound, LLC
EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
II
2025-10-09
K250026
Wuxi Hisky Medical Technologies Co., Ltd.
Shear Wave Quantificational Ultrasound Diagnostic System (FH9000/FH7000/FH6000/FH5000/FH3000/FH1000)
II
2025-10-01
K251192
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
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)
II
2025-08-22
K251481
Siemens Medical Solutions USA, Inc.
ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound System
II
2025-08-20
K251455
Philips Ultrasound, LLC
EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
II
2025-07-24
K250913
Jiangsu Tingsn Technology Co., Ltd.
TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System
II
2025-07-19
K250999
Samsung Medison Co., Ltd.
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
II
2025-07-18
K250772
Surgical Instrument Service and Savings, Inc.
Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheter
II
2025-07-11
K243274
Centers for Disease Control and Prevention
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A SubTyping Kit (VER 4); Influenza B Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4)
II
2025-07-11
K250310
Boston Scientific Corporation
VIKING Fixed Curve Diagnostic Catheter
II
2025-06-27
K250886
Philips Ultrasound, LLC
EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems
II
2025-06-18
K243880
Wuxi Hisky Medical Technologies Co., Ltd.
Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100)
II
2025-06-17
K250545
Surgical Instrument Service and Savings, Inc.
Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG)
II
2025-06-05
K250024
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
TE Air Diagnostic Ultrasound System
II
2025-05-30
K243793
Philips Ultrasound, LLC
EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
II
2025-05-21
K243411
Nanjing Perlove Medical Equipment Co., Ltd.
Diagnostic X-ray System
II
2025-05-19
K250020
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
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
II
2025-05-19
K250110
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
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);
II
2025-05-16
K242519
Philips Ultrasound
Lumify Diagnostic Ultrasound System
II
2025-05-15
K242808
Canon Medical Systems Corporation
Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5
II
2025-05-13
K251110
Philips Ultrasound, LLC
EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems
II
2025-05-09
K242670
Philips Ultrasound
Lumify Diagnostic Ultrasound System
II
2025-05-08
K250228
Esonic Technology (Wuhan) Co., Ltd.
eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R, eHertz S)
II
2025-04-23
K250177
Philips Ultrasound, LLC
EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
II
2025-04-10
K243298
Carbon (Shenzhen) Medical Device Co., Ltd.
Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound System
II
2025-04-03
K243931
Centers for Disease Control and Prevention
CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A Subtyping Kit (VER 4); Influenza B Lineage Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4)
II
2025-03-14
K250214
Edan Instruments, Inc.
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)
II
2025-02-20
K243702
Samsung Medison Co., Ltd.
V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System
II
2025-02-12
K243794
Philips Ultrasound, LLC
EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
II
2025-02-06
K242019
DRGEM Corporation
GXR-Series Diagnostic X-Ray System
II
2025-01-07
K240676
Vinno Technology (Suzhou) Co.,Ltd
ULTIMUS Series Ultrasound Diagnostic System
II
2024-12-16
K242020
Philips Ultrasound, LLC
EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
II
2024-12-12
K242511
Samsung Medison Co., Ltd.
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
II
2024-12-10
K242225
Surgical Instrument Service and Savings, Inc.
Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter
II
2024-11-29
K242444
Samsung Medison Co., Ltd.
HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System
II
2024-11-27
K242523
Siemens Medical Solutions USA, Inc.
ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound System
II
2024-11-19
K242496
Eieling Technology (Shenzhen) Limited
Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C)
II
2024-11-19
K243299
Siemens Medical Solutions USA, Inc.
ACUSON Redwood Diagnostic Ultrasound System
II
2024-11-15
K242231
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
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
II
2024-11-08
K240366
Boston Scientific Corporation
EPXT Unidirectional Steerable Diagnostic Catheter; Dynamic Tip Unidirectional Steerable Diagnostic Catheter; Dynamic XT Unidirectional Steerable Diagnostic Catheter
II
2024-11-01
K242809
Medical Graphics Corporation
Ascent Cardiorespiratory Diagnostic Software
II
2024-10-17
K241971
Samsung Medison Co., Ltd.
HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound System
II
2024-10-11
K240980
Philips Ultrasound, LLC
EPIQ Series Diagnostic Ultrasound System
II
2024-10-07
K241201
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
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
II
2024-09-16
K241432
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System
II
2024-09-12
K241582
Canon Medical Systems Corporation
Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800, TUS-AI700)
II
2024-09-12
K233433
Medtronic
Sphere-9Dx Diagnostic Catheter (AFR-00009)
II
2024-08-07
K240906
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
TE Air Diagnostic Ultrasound System
II
2024-07-23
K240704
Siemens Medical Solutions USA, Inc.
ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System, ACUSON Origin ICE Diagnostic Ultrasound System
II
2024-07-22
K234091
Genalyte, Inc.
Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0
II
2024-07-22
K233453
Life Technologies Corporation
Applied Biosystems TaqPath COVID-19 Diagnostic PCR Kit
II
2024-07-10
K231015
Innovative Health, LLC
Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters
II
2024-07-01
K240631
Samsung Medison Co., Ltd.
V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System
II
2024-06-21
K240684
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
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
II
2024-06-17
K233613
Siemens Medical Solutions USA, Inc.
ACUSON SC2000 Diagnostic Ultrasound System
II
2024-06-12
K240516
Samsung Medison Co., Ltd.
RS85 Diagnostic Ultrasound System
II
2024-06-12
K233825
Innovative Health
Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter
II
2024-06-07
K241110
Centers for Disease Control and Prevention
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4)
II
2024-05-21
K233841
Qingdao Hisense Medical Equipment Co., Ltd.
HD80 Series Ultrasound Diagnostic System
II
2024-05-16
K232895
Contec Medical Systems Co.,Ltd
B-Ultrasound Diagnostic System
II
2024-05-03
K232908
Contec Medical Systems Co.,Ltd
Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound Diagnostic System (CMS1700C)
II
2024-05-02
K240850
Philips Ultrasound, LLC
EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems
II
2024-04-24
K240115
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
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
II
2024-04-22
K231930
Guangdong Youkey Medical Co., Ltd.
Digital Ultrasonic Diagnostic Imaging System (Model: F6)
II
2024-03-22
K233439
Qingdao Hisense Medical Equipment Co., Ltd.
HD60 Series Ultrasound Diagnostic System
II
2024-02-21
K231659
Medisono
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)
II
2024-02-15
K233788
Philips Ultrasound, LLC
EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System
II
2024-02-13
K233401
Eieling Technology Limited
Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile)
II
2024-02-12
K233195
Canon Medical Systems Corporation
Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System
II
2024-01-24
K233226
Radical Imaging, LLC
FlexView Diagnostic (v1.1.20)
II
2024-01-17
K233112
Samsung Medison Co., Ltd.
HM70 EVO Diagnostic Ultrasound System
II
2023-12-21
K231889
Ultrasound Biotechnology (Shanghai) Co., Ltd.
Endoscopic Ultrasonic Diagnostic Equipment /Disposable Sterile Endoscopic Ultrasonic Probe (USW-S1,USW140-S20MS)
II
2023-12-21
K233397
Medtronic, Inc.
Cosine-10TM Diagnostic Catheter
II
2023-12-02
K233545
Philips Ultrasound, LLC
EPIQ Series Diagnostic Ultrasound System
II
2023-11-30
K232988
Canon Medical Systems Corporation
Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound System
II
2023-11-21
K232145
Siemens Medical Solutions USA, Inc.
ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System
II
2023-10-30
K233207
Boston Scientific Corporation
Polaris X Unidirectional Steerable Diagnostic Catheter
II
2023-10-27
K231761
Skanray Technologies Limited
PodSKAN HF Diagnostic X-ray System
II
2023-10-27
K231685
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
TE Air Diagnostic Ultrasound System
II
2023-10-26
K232500
Philips Ultrasound
Lumify Diagnostic Ultrasound System
II
2023-10-26