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 5 of 12
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K181336 | HS50 / HS60 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2018-12-04 | Traditional | PDF ↗ |
| K182277 | Versana Premier | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2018-11-21 | Traditional | PDF ↗ |
| K182715 | Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound System | Shenzhen Wisonic Medical Technology Co. , Ltd. | 2018-11-20 | Traditional | PDF ↗ |
| K181985 | Voluson E6, Voluson E8, Voluson E10 | GE Healthcare | 2018-11-15 | Traditional | PDF ↗ |
| K182603 | Z6 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2018-11-14 | Traditional | PDF ↗ |
| K182857 | EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2018-11-09 | Traditional | PDF ↗ |
| K181934 | Vivid T8, Vivid T9 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2018-11-06 | Traditional | PDF ↗ |
| K182596 | Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System | Canon Medical Systems Corporation | 2018-11-02 | Traditional | PDF ↗ |
| K182427 | Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound System | Canon Medical Systems Corporation | 2018-11-02 | Traditional | PDF ↗ |
| K182679 | Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1 | Canon Medical Systems Corporation | 2018-10-31 | Traditional | PDF ↗ |
| K181685 | Vivid E80, Vivid E90, Vivid E95 | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2018-10-25 | Traditional | PDF ↗ |
| K182529 | Xperius Ultrasound System | Philips Ultrasound, Inc. | 2018-10-23 | Traditional | PDF ↗ |
| K182450 | Vivid S60N, Vivid S70N | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2018-10-19 | Traditional | PDF ↗ |
| K181617 | E-CUBE 8 | Alpinion Medical Systems Co., Ltd. | 2018-10-11 | Traditional | PDF ↗ |
| K181277 | E-CUBE 12 | Alpinion Medical Systems Co., Ltd. | 2018-09-28 | Traditional | PDF ↗ |
| K181783 | LOGIQ P9; LOGIQ P7 | GE Healthcare | 2018-09-20 | Traditional | PDF ↗ |
| K181313 | BenQ Diagnostic Ultrasound System | Qisda Corporation | 2018-08-27 | Traditional | PDF ↗ |
| K180974 | CBit Series Digital Color Doppler Ultrasound System | CHISON Medical Technologies Co., Ltd. | 2018-08-17 | Traditional | PDF ↗ |
| K180737 | Ultrasound Scanner System bk2300 | Bk Medical Aps | 2018-08-01 | Traditional | PDF ↗ |
| K180912 | TE7/TE5 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2018-07-30 | Traditional | PDF ↗ |
| K181485 | EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2018-07-27 | Traditional | PDF ↗ |
| K181376 | ARIETTA 65 | Hitachi Healthcare Americas Corporation | 2018-07-18 | Traditional | PDF ↗ |
| K173801 | Transcranial Doppler Ultrasound System | Shenzhen Delica Medical Equipment Co., Ltd. | 2018-07-11 | Special | PDF ↗ |
| K173486 | NTU-USB Ultrasound USB Box | National Taiwan University | 2018-07-11 | Traditional | PDF ↗ |
| K180995 | Vscan Extend | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2018-06-25 | Traditional | PDF ↗ |
| K181098 | ACUSON SC2000 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2018-05-31 | Traditional | PDF ↗ |
| K180572 | AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10 | Supersonic Imagine | 2018-05-29 | Traditional | PDF ↗ |
| K180862 | Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound System | Edan Instruments, Inc. | 2018-05-24 | Traditional | PDF ↗ |
| K180455 | NeuralBot | Neural Analytics, Inc. | 2018-05-22 | Traditional | PDF ↗ |
| K173810 | Ventripoint Medical System Plus (VMS+) | Ventripoint Diagnostics , Ltd. | 2018-05-14 | Traditional | PDF ↗ |
| K180799 | Clarius Ultrasound Scanner | Clarius Mobile Health Corp. | 2018-05-14 | Traditional | PDF ↗ |
| K180409 | HS40 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2018-05-11 | Traditional | PDF ↗ |
| K180461 | Navi e/Navi s/Navi X Diagnostic Ultrasound System | Shenzhen Wisonic Medical Technology Co. , Ltd. | 2018-05-09 | Traditional | PDF ↗ |
| K180599 | Venue | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2018-05-02 | Traditional | PDF ↗ |
| K173962 | Viamo c100 TUS-VC100 Diagnostic Ultrasound System | Toshibamedical Systems Corporation | 2018-04-20 | Traditional | PDF ↗ |
| K180704 | SonoSite iViz Ultrasound System | FUJIFILM Sonosite, Inc. | 2018-04-13 | Abbreviated | PDF ↗ |
| K180408 | U60 Diagnostic Ultrasound System | Edan Instruments, Inc. | 2018-04-13 | Special | PDF ↗ |
| K180535 | Voluson P6 and Voluson P8 | GE Healthcare | 2018-03-29 | Special | PDF ↗ |
| K180374 | Voluson S8/ Voluson S10/ Voluson S10 Expert | GE Healthcare | 2018-03-13 | Special | PDF ↗ |
| K173713 | HS70A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2018-03-08 | Traditional | PDF ↗ |
| K173739 | ALOKA ARIETTA 850 | Hitachi Healthcare Americas Corporation | 2018-02-28 | Traditional | PDF ↗ |
| K173569 | Ultrasound System 1300 | Bk Medical Aps | 2018-02-23 | Abbreviated | PDF ↗ |
| K173513 | WS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2018-02-20 | Traditional | PDF ↗ |
| K180067 | ACUSON X800 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2018-02-07 | Traditional | PDF ↗ |
| K173204 | RS85 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2018-02-05 | Traditional | PDF ↗ |
| K173981 | ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. Ultrasound Group | 2018-02-02 | Traditional | PDF ↗ |
| K173957 | ACUSON NX3 Diagnostic Ultrasound System; ACUSON NX3 ELITE Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2018-02-01 | Traditional | PDF ↗ |
| K180039 | ACUSON P600 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2018-02-01 | Traditional | PDF ↗ |
| K173291 | 6440 Ultrasound System | Esaote, S.p.A. | 2018-01-12 | Traditional | PDF ↗ |
| K173090 | Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4 | Toshibamedical Systems Corporation | 2018-01-11 | Traditional | PDF ↗ |
| K173021 | Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic Systems | Supersonic Imagine | 2018-01-09 | Traditional | PDF ↗ |
| K173471 | DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2018-01-08 | Traditional | PDF ↗ |
| K172860 | Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite Diagnostic Ultrasound System/Resona 6S/Resona 6PRO/Resona 6OB Diagnostic Ultrasound System /Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2018-01-02 | Traditional | PDF ↗ |
| K163712 | Clover 50/Clover60/Clover70 Diagnostic Ultrasound System | Shenzhen Wisonic Medical Technology Co. , Ltd. | 2018-01-02 | Traditional | PDF ↗ |
| K173555 | LOGIQ E10 | GE Healthcare | 2017-12-20 | Traditional | PDF ↗ |
| K172732 | E-CUBE 8 | Alpinion Medical Systems Co., Ltd. | 2017-12-14 | Traditional | PDF ↗ |
| K173369 | DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. | 2017-12-13 | Traditional | PDF ↗ |
| K172276 | Xario 200 Diagnostic Ultrasound System V6.0 | Toshibamedical Systems Corporation | 2017-12-12 | Traditional | PDF ↗ |
| K173000 | Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color Doppler Ultrasound Imaging System | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) | 2017-12-07 | Traditional | PDF ↗ |
| K172993 | P20 Series Digital Color Doppler Ultrasound System | Sonoscape Medical Corp. | 2017-12-05 | Traditional | PDF ↗ |
| K173058 | P10 Series Digital Color Doppler Ultrasound System | Sonoscape Medical Corp. | 2017-12-01 | Traditional | PDF ↗ |
| K173003 | U50 Diagnostic Ultrasound System | Edan Instruments, Inc. | 2017-11-15 | Special | PDF ↗ |
| K170859 | Dolphin/IQ and Dolphin/4D | Viasonix , Ltd. | 2017-11-14 | Traditional | PDF ↗ |
| K173265 | UltraVision 2 Diagnostic Ultrasound System | Winprobe Corporation | 2017-11-07 | Abbreviated | PDF ↗ |
| K173341 | Vivid E80, Vivid E90, Vivid E95 | GE Medical Systems | 2017-11-02 | Traditional | PDF ↗ |
| K171708 | ALOKA ARIETTA 850 | Hitachi Healthcare Americas Corporation | 2017-10-31 | Traditional | PDF ↗ |
| K171926 | C5 Diagnostic Ultrasound System | Guangzhou Sonostar Technologies Co., Ltd. | 2017-10-27 | Traditional | PDF ↗ |
| K172970 | M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2017-10-25 | Traditional | PDF ↗ |
| K171579 | M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2017-10-18 | Traditional | PDF ↗ |
| K170085 | SONON Ultrasound Imaging System, Model: 300L | Healcerion Co., Ltd. | 2017-10-12 | Traditional | PDF ↗ |
| K172059 | LinkQuest Diagnostic Ultrasound System model SQ860 | Linkquest, Inc. | 2017-10-05 | Traditional | PDF ↗ |
| K172607 | Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System | Philips Health Care | 2017-10-04 | Traditional | PDF ↗ |
| K172380 | U2 Diagnostic Ultrasound System | Edan Instruments, Inc. | 2017-09-29 | Traditional | PDF ↗ |
| K172342 | Voluson E6, Voluson E8, Voluson E10 | GE Healthcare | 2017-09-29 | Traditional | PDF ↗ |
| K171891 | ZS3 Ultrasound System, z.one pro Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2017-09-21 | Traditional | PDF ↗ |
| K172082 | S60 Series Digital Color Doppler Ultrasound System | Sonoscape Medical Corp. | 2017-09-21 | Traditional | PDF ↗ |
| K172385 | Clarius Ultrasound System | Clarius Mobile Health Corp. | 2017-09-14 | Abbreviated | PDF ↗ |
| K171233 | Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. | 2017-09-12 | Traditional | PDF ↗ |
| K163510 | Poseidon Ultrasound System | Butterfly Network, Inc. | 2017-09-06 | Traditional | PDF ↗ |
| K172055 | DUS-7000 Digital Color Doppler Ultrasound System | Advanced Instrumentations, Inc. | 2017-08-31 | Abbreviated | PDF ↗ |
| K171048 | RS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2017-08-24 | Traditional | PDF ↗ |
| K171900 | Acclarix AX4 Diagnostic Ultrasound System | Edan Instruments, Inc. | 2017-08-18 | Traditional | PDF ↗ |
| K172162 | ACUSON S3000 S2000 S1000 Diagnostic Ultrasound Systems | Siemens Healthcare | 2017-08-16 | Traditional | PDF ↗ |
| K172374 | ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2017-08-15 | Traditional | PDF ↗ |
| K163121 | SmartUs EXT-1M/3M | Telemed | 2017-08-10 | Traditional | PDF ↗ |
| K171070 | WS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2017-08-09 | Traditional | PDF ↗ |
| K172129 | HS40 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2017-08-08 | Traditional | PDF ↗ |
| K171164 | U-Lite EXP | Sonoscanner | 2017-08-03 | Traditional | PDF ↗ |
| K170999 | P50 Series Digital Color Doppler Ultrasound System | Sonoscape Medical Corp. | 2017-07-12 | Traditional | PDF ↗ |
| K171000 | P60 Series Digital Color Doppler Ultrasound System | Sonoscape Medical Corp. | 2017-07-11 | Traditional | PDF ↗ |
| K171105 | AIXPLORER® & AIXPLORER® Ultimate Ultrasound Systems | Supersonic Imagine | 2017-07-11 | Traditional | PDF ↗ |
| K171034 | M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic Ultrasound System, M8 Elite Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2017-07-10 | Traditional | PDF ↗ |
| K170870 | Site~Rite Halcyon Diagnostic Ultrasound System | Chison Medical Imaging Co., Ltd. | 2017-07-06 | Traditional | PDF ↗ |
| K170714 | Venue | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2017-06-21 | Traditional | PDF ↗ |
| K170878 | Vivid S60N, Vivid S70N | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2017-06-14 | Traditional | PDF ↗ |
| K170823 | Vivid E80, Vivid E90, Vivid E95 | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2017-06-12 | Traditional | PDF ↗ |
| K171437 | SonoSite X-Porte Ultrasound System | FUJIFILM Sonosite, Inc. | 2017-06-12 | Traditional | PDF ↗ |
| K170374 | SonoBook Series Diagnostic Ultrasound System | Chison Medical Imaging Co., Ltd. | 2017-06-06 | Traditional | PDF ↗ |
| K170521 | TRINITY/3D PROSTATE SUITE | Koelis | 2017-05-30 | Traditional | PDF ↗ |
| K163505 | ARIETTA PRECISION | Hitachi , Ltd. | 2017-05-30 | Traditional | PDF ↗ |
Product code IYN · Class II · Radiology. Data: openFDA.