FDA Product Code
FDA Product Code IYN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.1550
510(k) Clearances — 1,186 records · page 2 of 12
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K242020 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | 2024-12-12 | Traditional | PDF ↗ |
| K243132 | 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) | Shantou Institute of Ultrasonic Instruments Co., Ltd. | 2024-12-10 | Traditional | PDF ↗ |
| K242511 | 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 | Samsung Medison Co., Ltd. | 2024-12-10 | Traditional | PDF ↗ |
| K242444 | HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2024-11-27 | Traditional | PDF ↗ |
| K242523 | ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2024-11-19 | Traditional | PDF ↗ |
| K243299 | ACUSON Redwood Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2024-11-15 | Traditional | PDF ↗ |
| K242800 | The 5000 Compact Series Ultrasound Systems | Philips Ultrasound, LLC | 2024-11-15 | Traditional | PDF ↗ |
| K242231 | 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 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2024-11-08 | Traditional | PDF ↗ |
| K241554 | Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L) | Telefield Medical Imaging (Shenzhen) Limited | 2024-10-24 | Traditional | PDF ↗ |
| K241971 | HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2024-10-11 | Traditional | PDF ↗ |
| K240980 | EPIQ Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | 2024-10-07 | Traditional | PDF ↗ |
| K242005 | Versana Premier; Versana Premier Lotus; LOGIQ F | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2024-10-02 | Traditional | PDF ↗ |
| K242223 | SuperSonic HepaVu | Supersonic Imagine | 2024-09-20 | Special | PDF ↗ |
| K234153 | EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220) | Edgelife Technologies, LLC | 2024-09-18 | Traditional | PDF ↗ |
| K241201 | 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 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2024-09-16 | Traditional | PDF ↗ |
| K241582 | Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800, TUS-AI700) | Canon Medical Systems Corporation | 2024-09-12 | Traditional | PDF ↗ |
| K241432 | MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2024-09-12 | Traditional | PDF ↗ |
| K241380 | FETOLY-HEART | Diagnoly | 2024-09-11 | Traditional | PDF ↗ |
| K241161 | 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 | Leltek, Inc. | 2024-09-11 | Special | PDF ↗ |
| K241051 | Vave Wireless Ultrasound System | Vave Health, Inc. | 2024-08-30 | Traditional | PDF ↗ |
| K233826 | Kosmos | EchoNous, Inc. | 2024-08-29 | Traditional | PDF ↗ |
| K241979 | Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro) | Beijing Konted Medical Technology Co.,Ltd | 2024-08-22 | Special | PDF ↗ |
| K233697 | SonoMax Series Digital Color Doppler Ultrasound System | CHISON Medical Technologies Co., Ltd. | 2024-08-09 | Traditional | PDF ↗ |
| K240906 | TE Air Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2024-07-23 | Traditional | PDF ↗ |
| K240704 | ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System, ACUSON Origin ICE Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2024-07-22 | Traditional | PDF ↗ |
| K240631 | V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2024-06-21 | Traditional | PDF ↗ |
| K240684 | 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 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2024-06-17 | Traditional | PDF ↗ |
| K233955 | Clarius OB AI | Clarius Mobile Health Corp. | 2024-06-14 | Traditional | PDF ↗ |
| K233610 | ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound System | Siemens Medical Solutions USA, Inc. | 2024-06-12 | Special | PDF ↗ |
| K240516 | RS85 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2024-06-12 | Traditional | PDF ↗ |
| K240206 | Venue Sprint | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2024-06-10 | Traditional | PDF ↗ |
| K240053 | Venue Go | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2024-06-10 | Traditional | PDF ↗ |
| K240111 | Venue | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2024-06-10 | Traditional | PDF ↗ |
| K234106 | Venue Fit | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2024-06-10 | Traditional | PDF ↗ |
| K233841 | HD80 Series Ultrasound Diagnostic System | Qingdao Hisense Medical Equipment Co., Ltd. | 2024-05-16 | Traditional | PDF ↗ |
| K232908 | Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound Diagnostic System (CMS1700C) | Contec Medical Systems Co.,Ltd | 2024-05-02 | Traditional | PDF ↗ |
| K240406 | Sonio Detect | Sonio | 2024-04-26 | Traditional | PDF ↗ |
| K240850 | EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems | Philips Ultrasound, LLC | 2024-04-24 | Special | PDF ↗ |
| K240115 | 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 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2024-04-22 | Traditional | PDF ↗ |
| K231930 | Digital Ultrasonic Diagnostic Imaging System (Model: F6) | Guangdong Youkey Medical Co., Ltd. | 2024-03-22 | Traditional | PDF ↗ |
| K233692 | Voluson Signature 20, Voluson Signature 18 | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2024-03-07 | Traditional | PDF ↗ |
| K233439 | HD60 Series Ultrasound Diagnostic System | Qingdao Hisense Medical Equipment Co., Ltd. | 2024-02-21 | Traditional | PDF ↗ |
| K231659 | 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) | Medisono | 2024-02-15 | Traditional | PDF ↗ |
| K233788 | EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | 2024-02-13 | Traditional | PDF ↗ |
| K233394 | Gem Flow Now (GEM2770-FN) | Synovis Micro Companies Alliance | 2024-01-28 | Traditional | PDF ↗ |
| K233195 | Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System | Canon Medical Systems Corporation | 2024-01-24 | Traditional | PDF ↗ |
| K232285 | U-Lite PRO | Sonoscanner Sarl | 2024-01-11 | Traditional | PDF ↗ |
| K232808 | Butterfly iQ3 Ultrasound System | Butterfly Network, Inc. | 2024-01-04 | Traditional | PDF ↗ |
| K233734 | Interson USB Ultrasound System | Interson Corporation | 2023-12-22 | Special | PDF ↗ |
| K233112 | HM70 EVO Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2023-12-21 | Traditional | PDF ↗ |
| K231354 | Pocket Ultrasound System (C10) | Beijing Konted Medical Technology Co.,Ltd | 2023-12-20 | Traditional | PDF ↗ |
| K232381 | LOGIQ Totus | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2023-12-07 | Traditional | PDF ↗ |
| K233597 | Sonosite LX Ultrasound System | FUJIFILM Sonosite, Inc. | 2023-12-06 | Traditional | PDF ↗ |
| K233545 | EPIQ Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | 2023-11-30 | Traditional | PDF ↗ |
| K230179 | 6440 MyLabX90 | Esaote, S.p.A. | 2023-11-29 | Traditional | PDF ↗ |
| K232988 | Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound System | Canon Medical Systems Corporation | 2023-11-21 | Traditional | PDF ↗ |
| K231941 | ARIETTA x10 | FUJIFILM Healthcare Americas Corporation | 2023-11-20 | Traditional | PDF ↗ |
| K231966 | LOGIQ E10 | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2023-11-07 | Traditional | PDF ↗ |
| K231989 | LOGIQ E10s, LOGIQ Fortis | Ge Medical Systems Ultrasound and Primary Care Diagnostic, | 2023-11-07 | Traditional | PDF ↗ |
| K232186 | LOGIQ e | Ge Medical Systems Ultrasound and Primary Care Diagnostic, | 2023-11-03 | Traditional | PDF ↗ |
| K232145 | ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2023-10-30 | Traditional | PDF ↗ |
| K231965 | Voluson Expert 22, Voluson Expert 20, Voluson Expert 18 | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2023-10-30 | Traditional | PDF ↗ |
| K231685 | TE Air Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2023-10-26 | Traditional | PDF ↗ |
| K232500 | Lumify Diagnostic Ultrasound System | Philips Ultrasound | 2023-10-26 | Traditional | PDF ↗ |
| K231509 | Aco Apache Ultrasound System | Aco Healthcare Co., Ltd. | 2023-10-24 | Traditional | PDF ↗ |
| K231764 | Ultrasound System 1300 | Bk Medical Aps | 2023-10-23 | Traditional | PDF ↗ |
| K232704 | Clarius Ultrasound Scanner | Clarius Mobile Health Corp. | 2023-10-05 | Special | PDF ↗ |
| K231772 | V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2023-10-03 | Traditional | PDF ↗ |
| K232336 | ES Series V2 | E-Scopics | 2023-09-26 | Special | PDF ↗ |
| K232617 | ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2023-09-26 | Traditional | PDF ↗ |
| K230066 | Carnation series Diagnostic Ultrasound System | Shenzhen Wisonic Medical Technology Co. , Ltd. | 2023-09-15 | Traditional | PDF ↗ |
| K231301 | Vscan Air | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2023-08-15 | Traditional | PDF ↗ |
| K230365 | Sonio Detect | Sonio | 2023-07-25 | Traditional | PDF ↗ |
| K230160 | VINNO G86,VINNO G86E,VINNO G65,VINNO G65P,VINNO G65E,VINNO G65D,VINNO M86, VINNO M86E,VINNO G90,VINNO G90E | Vinno Technology (Suzhou) Co.,Ltd | 2023-06-23 | Traditional | PDF ↗ |
| K230346 | Voluson SWIFT; Voluson SWIFT+ | Ge Medical Systems Ultrasound & Primary Care Diagnostic, LLC | 2023-06-20 | Traditional | PDF ↗ |
| K223920 | 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 | Vinno Technology (Suzhou) Co.,Ltd | 2023-06-17 | Traditional | PDF ↗ |
| K223917 | VINNO E20, VINNO E10,VINNO E10P,VINNO E10E, VINNO X1,VINNO X1E,VINNO X1P, VINNO X2,VINNO X2E,VINNO X2P | Vinno Technology (Suzhou) Co.,Ltd | 2023-06-17 | Traditional | PDF ↗ |
| K230768 | M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2023-06-09 | Traditional | PDF ↗ |
| K231190 | EPIQ Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | 2023-05-12 | Traditional | PDF ↗ |
| K223771 | Lumify Diagnostic Ultrasound System | Philips Ultrasound | 2023-05-04 | Traditional | PDF ↗ |
| K230084 | HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2023-04-21 | Traditional | PDF ↗ |
| K223564 | X-CUBE 50, X-CUBE 60 | Alpinion Medical Systems Co., Ltd. | 2023-04-17 | Traditional | PDF ↗ |
| K223830 | Ultrasound System 2300 | Bk Medical Aps | 2023-04-11 | Traditional | PDF ↗ |
| K223570 | SonoAir Series Digital Color Doppler Ultrasound System | CHISON Medical Technologies Co., Ltd. | 2023-03-31 | Traditional | PDF ↗ |
| K223017 | Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 | Canon Medical Systems Corporation | 2023-03-31 | Traditional | PDF ↗ |
| K223832 | Vivid S60N, Vivid S70N | Ge Medical System Ultrasound and Primary Care Diagnostics | 2023-02-16 | Traditional | PDF ↗ |
| K223407 | Versana Essential | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2023-02-15 | Traditional | PDF ↗ |
| K230207 | ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2023-02-13 | Traditional | PDF ↗ |
| K223387 | V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2023-02-13 | Traditional | PDF ↗ |
| K222596 | S90 Exp Series Digital Color Doppler Ultrasound System | Sonoscape Medical Corp. | 2023-02-10 | Traditional | PDF ↗ |
| K222928 | 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 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2023-02-07 | Traditional | PDF ↗ |
| K223735 | ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2023-02-06 | Special | PDF ↗ |
| K221911 | VINNO 6PRO, VINNO 6EXP, VINNO 5PRO, VINNO 5EXP, VINNO 3, VINNO 3PRO, VINNO 3EXP | Vinno Technology (Suzhou) Co.,Ltd | 2022-12-21 | Special | PDF ↗ |
| K222441 | Ultrasound System 2300 | Bk Medical Aps | 2022-12-07 | Traditional | PDF ↗ |
| K220983 | ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging System | Imsonic Medical China, Inc. | 2022-11-11 | Traditional | PDF ↗ |
| K222754 | ViewMate Multi Ultrasound System | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. | 2022-11-09 | Traditional | PDF ↗ |
| K222198 | Exo Iris (El2001) | Exo Imaging, Inc. | 2022-11-09 | Traditional | PDF ↗ |
| K222191 | Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC MACH40 | Supersonic Imagine | 2022-10-28 | Traditional | PDF ↗ |
| K222365 | Leltek Ultrasound Imaging System (Model: LU700 Series) | Leltek, Inc. | 2022-10-25 | Traditional | PDF ↗ |
| K221093 | X-CUBE 70, X-CUBE 90 | Alpinion Medical Systems Co., Ltd. | 2022-10-14 | Traditional | PDF ↗ |
Product code IYN · Class II · Radiology. Data: openFDA.