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 4 of 12
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K201988 | T-Lite | Sonoscanner | 2020-10-30 | Traditional | PDF ↗ |
| K201768 | Voluson E10 | GE Healthcare | 2020-10-22 | Traditional | PDF ↗ |
| K202737 | Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Xario200G and Xario100G, Diagnostic Ultrasound System | Canon Medical Systems Corporation | 2020-10-16 | Special | PDF ↗ |
| K202364 | Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1 | Canon Medical Systems Corporation | 2020-10-15 | Traditional | PDF ↗ |
| K202683 | ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System, ACUSON Freestyle Diagnostic Ultrasound System,ACUSON S1000, S2000, S3000 Diagnostic Ultrasound Systems, ACUSON P200 Diagnostic Ultrasound System, ACUSON P500 Diagnostic Ultrasound System, ACUSON NX3, NX3 Elite Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2020-10-15 | Special | PDF ↗ |
| K201828 | Voluson SWIFT, Voluson SWIFT+ | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2020-10-11 | Traditional | PDF ↗ |
| K201972 | Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1 | Canon Medical Systems Corporation | 2020-10-08 | Traditional | PDF ↗ |
| K202406 | Butterfly iQ Ultrasound System | Butterfly Network, Inc. | 2020-09-16 | Traditional | PDF ↗ |
| K200851 | Vivid T8, Vivid T9 | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2020-09-09 | Traditional | PDF ↗ |
| K200708 | Vivid iq | Ge Medical Systems Ultrasound And | 2020-09-09 | Traditional | PDF ↗ |
| K202216 | EPIQ Series Diagnostic Ultrasound Systems | Philips Ultrasound, Inc. | 2020-09-02 | Traditional | PDF ↗ |
| K202160 | Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound System, Sonosite X-Porte Ultrasound System, Sonosite Edge II Ultrasound System, Sonosite Maxx Ultrasound System | FUJIFILM Sonosite, Inc. | 2020-09-01 | Special | PDF ↗ |
| K201693 | DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80AExp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2020-08-21 | Traditional | PDF ↗ |
| K200780 | XBit Series Digital Color Doppler Ultrasound System | CHISON Medical Technologies Co., Ltd. | 2020-08-05 | Traditional | PDF ↗ |
| K201059 | S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System | Sonoscape Medical Corp. | 2020-07-30 | Traditional | PDF ↗ |
| K200643 | Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus 7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2020-07-24 | Traditional | PDF ↗ |
| K200743 | Vivid E80/ Vivid E90/ Vivid E95 | Ge Medical Systems Ultrasound And | 2020-07-23 | Traditional | PDF ↗ |
| K200497 | Vivid S60N, Vivid S70N | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2020-07-16 | Traditional | PDF ↗ |
| K200449 | X-Cube 90 | Alpinion Medical Systems Co., Ltd. | 2020-07-10 | Traditional | PDF ↗ |
| K200450 | X-Cube 70 | Alpinion Medical Systems Co., Ltd. | 2020-07-10 | Traditional | PDF ↗ |
| K201633 | Terason uSmart 3200T Plus Ultrasound System | Teratech Corporation | 2020-07-02 | Traditional | PDF ↗ |
| K200138 | Versana Premier | Ge Medical Systems Ultrasound And | 2020-07-01 | Traditional | PDF ↗ |
| K201462 | ACUSON Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2020-06-24 | Traditional | PDF ↗ |
| K200998 | Versana Active | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2020-06-11 | Traditional | PDF ↗ |
| K200979 | DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2020-05-28 | Traditional | PDF ↗ |
| K201130 | ACUSON Juniper Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2020-05-26 | Traditional | PDF ↗ |
| K192879 | Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic Ultrasound System | Edan Instruments, Inc. | 2020-05-21 | Traditional | PDF ↗ |
| K200964 | Sonosite PX Ultrasound System | FUJIFILM Sonosite, Inc. | 2020-05-08 | Traditional | PDF ↗ |
| K200699 | HS70A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2020-05-07 | Traditional | PDF ↗ |
| K201012 | EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2020-05-01 | Special | PDF ↗ |
| K200585 | Acuson SC2000 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2020-04-22 | Traditional | PDF ↗ |
| K200158 | LOGIQ E10 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2020-04-17 | Traditional | PDF ↗ |
| K200707 | ACUSON Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2020-04-15 | Traditional | PDF ↗ |
| K200644 | ACUSON Freestyle Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2020-04-10 | Special | PDF ↗ |
| K200001 | MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus ME7T Diagnostic Ultrasound System, MX8/ MX8T/ Vaus8/ ME8 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2020-04-09 | Traditional | PDF ↗ |
| K200411 | Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2020-04-08 | Traditional | PDF ↗ |
| K200339 | HS40 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2020-04-07 | Traditional | PDF ↗ |
| K200251 | Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2020-04-02 | Traditional | PDF ↗ |
| K200119 | LOGIQ E10s | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2020-04-01 | Traditional | PDF ↗ |
| K193518 | KOSMOS | EchoNous, Inc. | 2020-03-26 | Traditional | PDF ↗ |
| K192388 | SonoVision Ultrasound Imaging System | Tissue Differentiation Intelligence, LLC | 2020-03-12 | Abbreviated | PDF ↗ |
| K200304 | EPIQ Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2020-03-06 | Traditional | PDF ↗ |
| K191235 | Leltek Ultrasound Imaging System | Leltek, Inc. | 2020-02-12 | Traditional | PDF ↗ |
| K191347 | Paragon XHD Diagnostic Ultrasound System | Shenzhen Wisonic Medical Technology Co. , Ltd. | 2020-02-07 | Traditional | PDF ↗ |
| K193257 | ACUSON Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2020-01-31 | Traditional | PDF ↗ |
| K193510 | Terason uSmart3200T Ultrasound System | Teratech Corporation | 2020-01-28 | Traditional | PDF ↗ |
| K190120 | VINNO 8, VINNO 6, VINNO 5 | Vinno Technology (Suzhou) Co.,Ltd | 2020-01-23 | Traditional | PDF ↗ |
| K192903 | RS85 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2020-01-06 | Traditional | PDF ↗ |
| K192410 | ZS3 and z.one pro Ultrasound Systems | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2019-12-19 | Traditional | PDF ↗ |
| K192152 | DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2019-12-13 | Traditional | PDF ↗ |
| K192505 | HS50/HS60 Diagnostics Ultrasound System | Samsung Medison Co., Ltd. | 2019-12-12 | Traditional | PDF ↗ |
| K192319 | HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2019-12-10 | Traditional | PDF ↗ |
| K192157 | 6450 Ultrasound system | Esaote, S.p.A. | 2019-11-22 | Traditional | PDF ↗ |
| K191007 | Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems | Supersonic Imagine | 2019-10-25 | Traditional | PDF ↗ |
| K192835 | ACUSON NX3 Diagnostic Ultrasound System / ACUSON NX3 Elite Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2019-10-22 | Traditional | PDF ↗ |
| K192303 | ExactVu High Resolution Micro-Ultrasound System | Exact Imaging, Inc. | 2019-10-01 | Traditional | PDF ↗ |
| K192030 | RS80 EVO Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2019-09-19 | Traditional | PDF ↗ |
| K192254 | InnoSight Diagnostic Ultrasound System | Qisda Corporation | 2019-09-18 | Traditional | PDF ↗ |
| K191663 | Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0 | Canon Medical Systems Corporation | 2019-09-18 | Traditional | PDF ↗ |
| K192226 | Lumify Diagnostic Ultrasound System | Philips Health Care | 2019-09-06 | Traditional | PDF ↗ |
| K192107 | Clarius Ultrasound Scanner | Clarius Mobile Health Corp. | 2019-08-29 | Abbreviated | PDF ↗ |
| K192159 | Voluson E6, Voluson E8, Voluson E10 | GE Healthcare | 2019-08-29 | Traditional | PDF ↗ |
| K191922 | ACUSON P200 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2019-08-15 | Traditional | PDF ↗ |
| K191233 | ARIETTA 750 | Hitachi Healthcare Americas | 2019-08-09 | Traditional | PDF ↗ |
| K191792 | Versana Balance | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2019-08-09 | Traditional | PDF ↗ |
| K191798 | Versana Active | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2019-08-09 | Traditional | PDF ↗ |
| K191467 | Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0 | Canon Medical Systems Corporation | 2019-07-19 | Traditional | PDF ↗ |
| K183041 | Full Digital Colour Doppler Ultrasonic Diagnostic System | Wuhan Zoncare Bio-medical Electronics Co., Ltd. | 2019-07-10 | Traditional | PDF ↗ |
| K190228 | Transcranial Doppler Ultrasound System | Shenzhen Delica Medical Equipment Co., Ltd. | 2019-06-13 | Traditional | PDF ↗ |
| K191115 | RS85 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2019-06-12 | Special | PDF ↗ |
| K191055 | HS40 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2019-06-12 | Traditional | PDF ↗ |
| K191072 | 7410 Ultrasound System (MyLabSigma) | Esaote, S.p.A. | 2019-06-10 | Special | PDF ↗ |
| K190444 | HERA I10 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2019-05-22 | Traditional | PDF ↗ |
| K191023 | Dolphin/IQ, Dolphin/4D and Dolphin/MAX | Viasonix , Ltd. | 2019-05-16 | Special | PDF ↗ |
| K190995 | ExactVu High Resolution Micro-Ultrasound System | Exact Imaging, Inc. | 2019-05-10 | Special | PDF ↗ |
| K190989 | 6400 Ultrasound System (MyLabX6, MyLabX7) | Esaote, S.p.A. | 2019-05-10 | Special | PDF ↗ |
| K183660 | DP-10/DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2019-04-09 | Traditional | PDF ↗ |
| K182175 | TCD-X | Atys | 2019-04-05 | Traditional | PDF ↗ |
| K183377 | DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2019-04-04 | Traditional | PDF ↗ |
| K190248 | ARIETTA 50 | Hitachi Healthcare Americas | 2019-04-02 | Traditional | PDF ↗ |
| K190447 | 7400 Ultrasound Systems | Navigant Consulting - on Behalf of Esaote S.P.A. | 2019-04-01 | Special | PDF ↗ |
| K183575 | ACUSON S3000, S2000 Diagnostic Ultrasound System | Siemens Healthineers | 2019-03-20 | Traditional | PDF ↗ |
| K190476 | FUJIFILM Sonosite Vevo MD Imaging System | FUJIFILM Sonosite, Inc. | 2019-03-15 | Traditional | PDF ↗ |
| K190206 | DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2019-03-08 | Traditional | PDF ↗ |
| K182628 | Imagio Ultrasound Imaging System | Seno Medical Instruments, Inc. | 2019-03-05 | Traditional | PDF ↗ |
| K182932 | RS85 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2019-02-15 | Traditional | PDF ↗ |
| K183235 | SonoSite SII Ultrasound System | FUJIFILM Sonosite, Inc. | 2019-02-07 | Abbreviated | PDF ↗ |
| K182648 | X5 Series Digital Color Doppler Ultrasound System | Sonoscape Medical Corp. | 2019-01-29 | Traditional | PDF ↗ |
| K183456 | Aloka Arietta 850 | Hitachi Healthcare Americas | 2019-01-28 | Traditional | PDF ↗ |
| K183362 | Venue GO | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2019-01-28 | Traditional | PDF ↗ |
| K182594 | E-CUBE i7 | Alpinion Medical Systems Co., Ltd. | 2019-01-24 | Traditional | PDF ↗ |
| K182894 | HM70A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2019-01-22 | Traditional | PDF ↗ |
| K182636 | DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2019-01-10 | Traditional | PDF ↗ |
| K181637 | DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2019-01-09 | Traditional | PDF ↗ |
| K182632 | HS30 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2019-01-08 | Traditional | PDF ↗ |
| K182845 | minisono | Alpinion Medical Systems Co., Ltd. | 2018-12-27 | Traditional | PDF ↗ |
| K182165 | Color Doppler Ultrasound System; Model: mEye1 and mEye2 | Shenzhen Well.D Medical Electronics Co., Ltd. | 2018-12-20 | Traditional | PDF ↗ |
| K182595 | HERA W10 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2018-12-18 | Traditional | PDF ↗ |
| K181727 | Vivid iq | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2018-12-06 | Traditional | PDF ↗ |
| K183191 | 6420 Ultrasound System | Esaote, S.p.A. | 2018-12-04 | Special | PDF ↗ |
Product code IYN · Class II · Radiology. Data: openFDA.