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 6 of 12
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K163702 | Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1 | Toshibamedical Systems Corporation | 2017-05-30 | Traditional | PDF ↗ |
| K170303 | E5 Series Digital Color Doppler Ultrasound System | Sonoscape Medical Corp. | 2017-05-19 | Traditional | PDF ↗ |
| K170078 | Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12 Trolley, P12 Expert, P25 Trolley, and P25 Expert Trolley | Medisono, LLC | 2017-05-17 | Abbreviated | PDF ↗ |
| K163690 | 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. | 2017-04-20 | Traditional | PDF ↗ |
| K163443 | Interson USB Ultrasound System | Interson Corporation | 2017-04-13 | Traditional | PDF ↗ |
| K170445 | LOGIQ S8 | GE Healthcare | 2017-04-11 | Traditional | PDF ↗ |
| K170315 | Acuson SC2000 Diagnostic Ultrasound System | Siemens Medi Cal Solutions, Inc. | 2017-04-04 | Special | PDF ↗ |
| K170493 | HS50 / HS60 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2017-03-28 | Traditional | PDF ↗ |
| K170277 | DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2017-03-23 | Traditional | PDF ↗ |
| K163082 | 6200 Ultrasound System and 6250 Ultrasound System | Esaote, S.p.A. | 2017-03-16 | Traditional | PDF ↗ |
| K163688 | Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10 | Medisono, LLC | 2017-02-23 | Abbreviated | PDF ↗ |
| K163691 | HS70A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2017-02-22 | Traditional | PDF ↗ |
| K163596 | LOGIQ P9 and LOGIQ P7 | GE Healthcare | 2017-02-10 | Traditional | PDF ↗ |
| K162055 | Acclarix LX8 Diagnostic Ultrasound System | Edan Instruments, Inc. | 2017-01-31 | Traditional | PDF ↗ |
| K163635 | ACUSON S1000/S2000/S3000 Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc. Ultrasound Group | 2017-01-12 | Traditional | PDF ↗ |
| K163120 | EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50 Diagnostic Ultrasound System; Affiniti 70 Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2017-01-10 | Traditional | PDF ↗ |
| K163396 | ACUSON P500 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2017-01-04 | Traditional | PDF ↗ |
| K163427 | X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound System | Sonoscape Medical Corp. | 2017-01-03 | Special | PDF ↗ |
| K162845 | DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2016-12-15 | Traditional | PDF ↗ |
| K162902 | ARIETTA Prologue Diagnostic Ultrasound system and Transducers | Hitachi , Ltd. | 2016-12-15 | Traditional | PDF ↗ |
| K163138 | Clarius Ultrasound System | Clarius Mobile Health Corp. | 2016-11-30 | Abbreviated | PDF ↗ |
| K163077 | LOGIQ E9, LOGIQ E9 XDClear 2.0 | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2016-11-17 | Special | PDF ↗ |
| K162583 | ALOKA LISENDO 880 | Hitachi , Ltd. | 2016-11-17 | Traditional | PDF ↗ |
| K163020 | Xperius Ultrasound System | Philips Health Care | 2016-11-16 | Traditional | PDF ↗ |
| K161999 | Aixplorer | Supersonic Imagine | 2016-11-16 | Traditional | PDF ↗ |
| K162155 | Xario 200 Diagnostic Ultrasound System V5.0 | Toshibamedical Systems Corporation | 2016-11-01 | Traditional | PDF ↗ |
| K160442 | Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers | Neural Analytics, Inc. | 2016-10-21 | Traditional | PDF ↗ |
| K162065 | Ultrasound System SONIMAGE HS1 | Konica Minolta, Inc. | 2016-10-19 | Traditional | PDF ↗ |
| K160559 | NOBLUS Ultrasound Diagnostic System | Hitachi Medical Corporation | 2016-10-18 | Traditional | PDF ↗ |
| K161960 | bk2300 | Bk Medical Aps | 2016-10-17 | Traditional | PDF ↗ |
| K162290 | MyLabSix CrystaLine | Esaote, S.p.A. | 2016-10-14 | Traditional | PDF ↗ |
| K162549 | Lumify Ultrasound System | Philips Health Care | 2016-10-03 | Traditional | PDF ↗ |
| K162269 | Voluson E6, Voluson E8, Voluson E10 | GE Healthcare | 2016-10-03 | Special | PDF ↗ |
| K153539 | RS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2016-10-03 | Traditional | PDF ↗ |
| K162187 | Xario 100 Diagnostic Ultrasound System, V5.0 | Toshibamedical Systems Corporation | 2016-09-30 | Traditional | PDF ↗ |
| K162417 | Acuson Freestyle Ultrasound System | Siemens Medi Cal Solutions, Inc. | 2016-09-28 | Traditional | PDF ↗ |
| K161843 | Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0 | Toshibamedical Systems Corporation | 2016-09-21 | Traditional | PDF ↗ |
| K161439 | E-CUBE 11 | Alpinion Medical Systems Co., Ltd. | 2016-09-21 | Traditional | PDF ↗ |
| K162172 | EBit Series Diagnostic Ultrasound System | Chison Medical Imaging Co., Ltd. | 2016-09-14 | Traditional | PDF ↗ |
| K162329 | CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System | Philips Health Care | 2016-09-14 | Traditional | PDF ↗ |
| K162288 | SonoSite iViz Ultrasound System | FUJIFILM Sonosite, Inc. | 2016-09-08 | Abbreviated | PDF ↗ |
| K162267 | Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2016-09-06 | Special | PDF ↗ |
| K162243 | ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound System | Siemens Medi Cal Solutions, Inc. | 2016-09-06 | Traditional | PDF ↗ |
| K162221 | ACUSON SC2000 Diagnostic Ultrasound System | Siemens Medical Solutions Inc. Ultrasound Group | 2016-09-06 | Special | PDF ↗ |
| K161168 | MyLabSix Ultrasound System | Esaote Europe B.V. | 2016-09-02 | Traditional | PDF ↗ |
| K161588 | Vscan Extend | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2016-08-31 | Traditional | PDF ↗ |
| K162094 | RS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2016-08-26 | Traditional | PDF ↗ |
| K162045 | SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound System | FUJIFILM Sonosite, Inc. | 2016-08-18 | Traditional | PDF ↗ |
| K161224 | LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2016-08-05 | Traditional | PDF ↗ |
| K161706 | Vivid iq | Ge Medical Systems Ultrasound and Primary Care Diagnostics L | 2016-08-05 | Traditional | PDF ↗ |
| K161787 | ACUSON NX2 Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc. | 2016-07-28 | Traditional | PDF ↗ |
| K161359 | 6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System | Esaote, S.p.A. | 2016-07-19 | Traditional | PDF ↗ |
| K161525 | TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2016-07-13 | Traditional | PDF ↗ |
| K160853 | Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging System | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) | 2016-06-27 | Traditional | PDF ↗ |
| K161119 | SonoSite iViz Ultrasound System | FUJIFILM Sonosite, Inc. | 2016-05-13 | Traditional | PDF ↗ |
| K161047 | LOGIQ P9 and LOGIQ P7 | GE Healthcare | 2016-05-05 | Special | PDF ↗ |
| K153277 | 6200 Ultrasound System and 6250 Ultrasound System | Esaote, S.p.A. | 2016-05-04 | Traditional | PDF ↗ |
| K160357 | TRINITY | Koelis | 2016-05-02 | Traditional | PDF ↗ |
| K160162 | Voluson P6, Voluson P8 | GE Healthcare | 2016-04-26 | Traditional | PDF ↗ |
| K160674 | Fujifilm Sonosite Vevo MD Imaging System | FUJIFILM Sonosite, Inc. | 2016-04-19 | Traditional | PDF ↗ |
| K160343 | SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner | Beijing East Whale Imaging Technology Co., Ltd. | 2016-04-07 | Traditional | PDF ↗ |
| K160807 | EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2016-04-06 | Traditional | PDF ↗ |
| K160734 | SonoSite SII Ultrasound System | FUJIFILM Sonosite, Inc. | 2016-04-05 | Traditional | PDF ↗ |
| K160790 | Acclarix LX8 Diagnostic Ultrasound System | Edan Instruments, Inc. | 2016-04-04 | Traditional | PDF ↗ |
| K160283 | S45 Digital Color Doppler Ultrasound System | Sonoscape Medical Corp. | 2016-04-04 | Traditional | PDF ↗ |
| K160258 | X5 Digital Color Doppler Ultrasound System | Sonoscape Medical Corp. | 2016-04-01 | Traditional | PDF ↗ |
| K160277 | LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6 | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2016-03-25 | Traditional | PDF ↗ |
| K160406 | FUJIFILM FC1 Ultrasound System | FUJIFILM Sonosite, Inc. | 2016-03-16 | Traditional | PDF ↗ |
| K160078 | Vivid T8 | Ge Medical Systems Ultrasound and Primary Care Diagnotics, L | 2016-03-10 | Traditional | PDF ↗ |
| K160381 | TE7 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2016-03-09 | Special | PDF ↗ |
| K160182 | LOGIQ S7 Expert | GE Healthcare | 2016-02-26 | Special | PDF ↗ |
| K153424 | E-CUBE i7 | Alpinion Medical Systems Co., Ltd. | 2016-02-26 | Traditional | PDF ↗ |
| K160184 | Voluson S6, Voluson S8, Voluson S10 | GE Healthcare | 2016-02-25 | Traditional | PDF ↗ |
| K153529 | WS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2016-02-02 | Traditional | PDF ↗ |
| K153421 | HI VISION ASCENDUS, HV ASCENDUS, ASCENDUS | Hitachi Aloka Medical America, Inc. | 2016-01-21 | Traditional | PDF ↗ |
| K153626 | SonoSite Edge II Ultrasound System | FUJIFILM Sonosite, Inc. | 2016-01-20 | Traditional | PDF ↗ |
| K152854 | S50 Digital Color Doppler Ultrasound System | Sonoscape Medical Corp. | 2016-01-13 | Traditional | PDF ↗ |
| K153037 | LOGIQ V1/ LOGIQ V2 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2016-01-04 | Traditional | PDF ↗ |
| K153085 | Q Series Diagnostic Ultrasound System | Chison Medical Imaging Co., Ltd. | 2015-12-21 | Traditional | PDF ↗ |
| K153408 | HM70A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2015-12-21 | Traditional | PDF ↗ |
| K153480 | ClearVue850 Diagnostic Ultrasound System | Philips Health Care | 2015-12-16 | Traditional | PDF ↗ |
| K152467 | Touch Ultrasound | Carestream Health, Inc. | 2015-12-09 | Abbreviated | PDF ↗ |
| K152758 | Venue 50 | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2015-11-18 | Traditional | PDF ↗ |
| K152983 | FUJIFILM SonoSite iViz Ultrasound System | FUJIFILM Sonosite, Inc. | 2015-11-12 | Traditional | PDF ↗ |
| K152567 | Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound System | GE Healthcare | 2015-11-06 | Special | PDF ↗ |
| K152962 | HS70A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2015-11-02 | Traditional | PDF ↗ |
| K152899 | Philips Lumify Diagnostic Ultrasound System | Philips Healthcare, Inc. | 2015-10-30 | Traditional | PDF ↗ |
| K152543 | M9/M9CV/M9T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015-10-29 | Traditional | PDF ↗ |
| K152763 | Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015-10-21 | Traditional | PDF ↗ |
| K152577 | ULTRASOUND SYSTEM SONIMAGE HS 1 | Konica Minolta, Inc. | 2015-10-08 | Special | PDF ↗ |
| K152369 | ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond System | Siemens Medical Solutions USA, Inc. Ultrasound Group | 2015-10-06 | Traditional | PDF ↗ |
| K151910 | Ultrasound Scanner System BK2300 | Bk Medical Aps | 2015-10-05 | Abbreviated | PDF ↗ |
| K152545 | DC-60/DC-60S/DC-60 EXP/DC-55 Diagnostic Ultrasound Systems | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015-10-02 | Traditional | PDF ↗ |
| K152195 | LOGIQ S8 | GE Healthcare | 2015-09-29 | Traditional | PDF ↗ |
| K152469 | ACUSON NX3 Elite / NX3 Diagnostic Ultrasound System | Siemens Medical Solutions, Inc., Ultrasound Division | 2015-09-21 | Traditional | PDF ↗ |
| K152052 | Ultrasound Scanner System bk2300 | Bk Medical Aps | 2015-09-16 | Special | PDF ↗ |
| K152309 | LOGIQ E9, LOGIQ E9 XDClear 2.0 | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2015-09-14 | Special | PDF ↗ |
| K152396 | S12 Digital Color Doppler Ultrasound System | Sonoscape Medical Corp. | 2015-09-03 | Special | PDF ↗ |
| K152250 | SpeqRT | Signostics Limited | 2015-09-03 | Traditional | PDF ↗ |
| K142982 | OPUS 5100 Diagnostic Doppler Ultrasound System | Chang Gung Medical Technology Co., Ltd. | 2015-09-03 | Traditional | PDF ↗ |
Product code IYN · Class II · Radiology. Data: openFDA.