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 8 of 12
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K132059 | DIAGNOSTIC ULTRASOUND SYSTEM | Advanced Instrumentations, Inc. | 2013-10-25 | Traditional | PDF ↗ |
| K132804 | ACUSON S1000 / S2000 / S3000 | Siemens Medical Solutions USA, Inc. Ultrasound Gro | 2013-10-24 | Traditional | PDF ↗ |
| K132942 | SITE-RITE VISION II ULTRASOUND SYSTEM | C.R. Bard, Inc. | 2013-10-17 | Special | PDF ↗ |
| K130881 | ACUSON S2000 AND S3000 | Siemens Medical Solutions USA, Inc. | 2013-10-11 | Traditional | PDF ↗ |
| K132768 | S8 EXP PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM | Sonoscape Company Limited | 2013-10-04 | Special | PDF ↗ |
| K132861 | UGEO H60 DIAGNOSTIC ULTRASOUND SYSTEM | Samsung Medison Co., Ltd. | 2013-10-04 | Traditional | PDF ↗ |
| K132274 | AIXPLORER | Supersonic Imagine | 2013-09-24 | Special | PDF ↗ |
| K131937 | VOLUSON I/E | GE Healthcare | 2013-09-24 | Traditional | PDF ↗ |
| K132171 | AIXPLORER | Supersonic Imagine | 2013-09-24 | Traditional | PDF ↗ |
| K131507 | XARIO 200 DIAGNOSTIC ULTRASOUND SYSTEM | Toshibamedical Systems Corporation | 2013-08-28 | Traditional | PDF ↗ |
| K131527 | LOGIQ S8 | GE Healthcare | 2013-08-26 | Traditional | PDF ↗ |
| K132304 | EPIQ DIAGNOSTIC ULTRASOUND SYSTEM | Philips Ultrasound, Inc. | 2013-08-21 | Traditional | PDF ↗ |
| K132341 | DC-8/ DC-8 PRO/ DC-8 CV/ DC-8 EXP/ DC-8S DIAGNOSTIC ULTRASOUND SYSTEMS | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2013-08-15 | Traditional | PDF ↗ |
| K131305 | CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINCAR PROBE, PHASED PROBE | Chison Medical Imaging Co., Ltd. | 2013-08-01 | Traditional | PDF ↗ |
| K131514 | GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM | Ge Vingmed Ultrasound AS | 2013-07-12 | Special | PDF ↗ |
| K131213 | DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM | Sonoscape Company Limited | 2013-06-21 | Traditional | PDF ↗ |
| K130833 | DP-20 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM; DP-30 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2013-06-21 | Traditional | PDF ↗ |
| K131267 | VOLUSON E6/E8/E8EXPERT/E8EXPERT LIMITED EDITION/E10 | GE Healthcare | 2013-06-19 | Special | PDF ↗ |
| K130695 | Z5 DIAGNOSTIC ULTRASOUND SYSTEM | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2013-06-19 | Traditional | PDF ↗ |
| K130499 | IU22 DIAGNOSTIC ULTRASOUND SYSTEM | Philips Ultrasound, Inc. | 2013-06-18 | Traditional | PDF ↗ |
| K130801 | DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM | Sonoscape Company Limited | 2013-06-14 | Traditional | PDF ↗ |
| K130739 | ACUSON S2000 AND S3000 DIAGNOSTIC ULTRASOUND SYSTEMS | Siemens Medical Solutions USA, Inc. | 2013-06-06 | Traditional | PDF ↗ |
| K131088 | PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM | Sonoscape Company Limited | 2013-05-24 | Traditional | PDF ↗ |
| K131209 | TERASON USMART3200T ULTRASOUND SYSTEM | Teratech Corp. | 2013-05-24 | Traditional | PDF ↗ |
| K130803 | UGEO H70C DIAGNOSTIC ULTRASOUND SYSTEM | Samsung Medison Co., Ltd. | 2013-04-12 | Traditional | PDF ↗ |
| K130119 | PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM | Sonoscape Company Limited | 2013-04-12 | Traditional | PDF ↗ |
| K122537 | PROUSOUND ALPHA 7 VER. 6.0 DIAGNOSTIC ULTRASOUND SYSTEM MODEL: PROSOUND ALPHA 7 VER. 6.0 | Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical | 2013-04-12 | Traditional | PDF ↗ |
| K130308 | NOBLUS ULTRASOUND DIAGNOSTIC SYSTEM | Hitachi Aloka Medical, Ltd. | 2013-04-05 | Special | PDF ↗ |
| K130659 | SPEQRT ULTRASOUND SYSTEM | Signostics Pty, Ltd. | 2013-04-03 | Traditional | PDF ↗ |
| K130173 | SONOSITE MAXX SERIES ULTRASOUND SYSTEM | FUJIFILM Sonosite, Inc. | 2013-03-25 | Traditional | PDF ↗ |
| K130754 | ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM | Siemens Medi Cal Solutions, Inc. | 2013-03-25 | Traditional | PDF ↗ |
| K130619 | ACUSON S1000 DIAGNOSTIC ULTRASOUND SYSTEM | Siemens Medical Solutions USA, Inc. | 2013-03-21 | Traditional | PDF ↗ |
| K130058 | ENDOSCOPIC ULTRASOUND CENTER EU-Y0008 | Olympus Medical Systems Corp. | 2013-02-22 | Traditional | PDF ↗ |
| K122710 | TRANSCRANIAL DOPPLER WITH ROBOTIC PROBE HEADBAND | Shenzhen Delicate Electronics Co., Ltd. | 2013-02-15 | Special | PDF ↗ |
| K123254 | ULTRASOUND SCANNER FLEX FOCUS | B-K Medical Aps | 2013-02-13 | Traditional | PDF ↗ |
| K123249 | DIAGNOSTIC ULTRASOUND SYSTEM | Edan Instruments, Inc. | 2013-02-08 | Traditional | PDF ↗ |
| K123992 | APLIO 500/400/300 V3.0 | Toshibamedical Systems Corporation | 2013-02-06 | Special | PDF ↗ |
| K123610 | E-CUBE 15 | Alpinion Medical Systems Co., Ltd. | 2013-02-01 | Traditional | PDF ↗ |
| K123828 | PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM | Hitachi Aloka Medical, Ltd. | 2013-01-18 | Traditional | PDF ↗ |
| K123611 | E-CUBE 7 | Alpinion Medical Systems Co., Ltd. | 2012-12-21 | Traditional | PDF ↗ |
| K123754 | CX50 3.0 DIAGNOSTIC ULTRASOUND SYSTEM | Philips Ultrasound, Inc. | 2012-12-21 | Traditional | PDF ↗ |
| K123564 | LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM | GE Healthcare | 2012-12-18 | Special | PDF ↗ |
| K123565 | PRESTO 1000 SYSTEM | Physiosonics, Inc. | 2012-12-13 | Traditional | PDF ↗ |
| K123503 | DC-N3/DC-NS3 DIAGNOSTIC ULTRASOUND SYSTEM | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2012-12-13 | Traditional | PDF ↗ |
| K123622 | ACUSON | Siemens Medical Solutions USA, Inc. | 2012-12-05 | Traditional | PDF ↗ |
| K123001 | ACUSON X700 DIAGNSTIC ULTRASOUND SYSTEM | Siemens Medical Solutions USA, Inc. | 2012-10-26 | Traditional | PDF ↗ |
| K121564 | ENDOSCOPIC ULTRASOUND CENTER EU-Y0006 | Olympus Medical Systems Corp. | 2012-10-16 | Traditional | PDF ↗ |
| K122009 | AIDA VI.8 DIAGNOSTIC ULTRASOUND GM-72P00A, L13-5V1 TRANSDUCER | Panasonic Healthcare Co., Ltd. | 2012-10-03 | Traditional | PDF ↗ |
| K122114 | LOGIQ S7 EXPERT, LOGIQ S7 PRO | GE Healthcare | 2012-10-03 | Traditional | PDF ↗ |
| K122825 | ACUSON | Siemens Medical Solutions USA, Inc. | 2012-09-28 | Traditional | PDF ↗ |
| K122341 | PROSOUND F37 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL: PROSOUND F37 | Hitachi Aloka Medical, Ltd. | 2012-09-26 | Traditional | PDF ↗ |
| K122327 | VOLUSON E6/E8/E8EXPERT/E10 | GE Healthcare | 2012-09-21 | Traditional | PDF ↗ |
| K121729 | E-CUBE 7 | Alpinion Medical Systems Co., Ltd. | 2012-09-20 | Traditional | PDF ↗ |
| K122491 | VIAMO SSA-640A V4.0 | Toshibamedical Systems Corporation | 2012-09-13 | Traditional | PDF ↗ |
| K122387 | VOLUSON P6, VOLUSON P8 | GE Healthcare | 2012-09-11 | Traditional | PDF ↗ |
| K121983 | DIAGNOSTIC DOPPLER ULTRASOUND SYSTEM CURVED LINEAR ARRAY 2-5 MHZ TRANSDUCER LINEAR ARRAY 5-11 MHZ TRANSDUCER PHASE ARRA | Benq Medical Technology Corpation | 2012-09-07 | Traditional | PDF ↗ |
| K122583 | UGEO G60 DIAGNOSTIC ULTRASOUND SYSTEM | Samsung Medison Co., Ltd. | 2012-09-05 | Traditional | PDF ↗ |
| K112255 | AIXPLORER | Supersonic Imagine | 2012-08-28 | Traditional | PDF ↗ |
| K121329 | AIXPLORER | Supersonic Imagine | 2012-08-24 | Traditional | PDF ↗ |
| K121063 | VIVID S5 DIAGNOSTIC ULTRASOUND SYSTEM, VIVID S6 DIAGNOSTIC ULTRASOUND SYSTEM | Ge Medical System Israel , Ltd. | 2012-08-21 | Traditional | PDF ↗ |
| K121867 | SONOTOUCH SERIES DIAGNOSTIC ULTRASOUND SYSTEMS | Chison Medical Imaging Co., Ltd. | 2012-08-02 | Traditional | PDF ↗ |
| K121937 | E-CUBE INNO | Alpinion Medical Systems Co., Ltd. | 2012-07-26 | Traditional | PDF ↗ |
| K122010 | Z6 DIAGNOSTIC ULTRASOUND SYSTEM | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2012-07-20 | Traditional | PDF ↗ |
| K121646 | ACUSON X150 DIAGNOSTIC ULTRASOUND SYSTEM SONOVISTA X150 DIAGNOSTIC ULTRASOUND SYSTEM | Siemens Medical Solutions USA, Inc. Ultrasound Gro | 2012-06-22 | Special | PDF ↗ |
| K121577 | APLIO ARTIDA DIAGNOSTIC ULTRASOUND SYSTEM | Toshiba Medical Systems Corporation, Japan | 2012-06-22 | Special | PDF ↗ |
| K121699 | ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM SONOVISTA X300 DIAGNOSTIC ULTRASOUND SYSTEM | Siemens Medical Solutions USA, Inc. | 2012-06-22 | Special | PDF ↗ |
| K113613 | DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM | Shantou Institute of Ultrasonic Instuments | 2012-06-15 | Traditional | PDF ↗ |
| K120801 | CHISON DIAGNOSTIC ULTRASOUND SYSTEM | Chison Medical Imaging Co., Ltd. | 2012-06-14 | Traditional | PDF ↗ |
| K121384 | MYLABSOGNO | Esaote, S.p.A. | 2012-05-23 | Special | PDF ↗ |
| K121138 | ACUSON S3000 DIAGNOSTIC ULTRASOUND SYSTEM | Siemens Medical Solution | 2012-05-17 | Traditional | PDF ↗ |
| K120741 | VOLUSON S6, VOLUSON S8 | GE Healthcare | 2012-04-27 | Traditional | PDF ↗ |
| K120699 | DC-T6 DIAGNOSTIC ULTRASOUND SYSTEM | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2012-04-19 | Traditional | PDF ↗ |
| K121010 | M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2012-04-19 | Traditional | PDF ↗ |
| K120234 | EZONO 3000 | Life-Tech, Inc. | 2012-04-19 | Traditional | PDF ↗ |
| K120703 | ZONARE ZS3 DIAGNOSTIC UNLTRASOUND SYSTEM | Zonare Medical Systems, Inc. | 2012-04-13 | Traditional | PDF ↗ |
| K120060 | E-CUBE 9 | Alpinion Medical Systems Co., Ltd. | 2012-03-16 | Traditional | PDF ↗ |
| K120321 | CLEARVUE 350/550 DIAGNOSTIC ULTRASOUND SYSTEM | Philips Health Care | 2012-02-17 | Traditional | PDF ↗ |
| K113612 | AIDA V1.5 DIAGNOSTIC ULTRASOUND SYSTEM GM-72P00A | Panasonic Healthcare Co., Ltd. | 2012-02-10 | Traditional | PDF ↗ |
| K112953 | TERASON T3000 ULTRASOUND SYSTEMS WITH UPDATED NEEDLE GUIDANCE GRAPHICS | Teratech Corp. | 2012-02-03 | Traditional | PDF ↗ |
| K113359 | CHISON DIAGNOSTIC ULTRASOUND SYSTEM,CONVEX PROBE,LINEAR PROBE,TRANSVAGINAL MICRO-CONVEX PROBE | Chison Medical Imaging Co., Ltd. | 2012-02-03 | Traditional | PDF ↗ |
| K113184 | LOGICSCAN 64 LOGICSCAN 128 | Telemed | 2012-01-26 | Traditional | PDF ↗ |
| K113663 | SONIXTABLET ULTRASOUND SCANNER | Ultrasonix Medical Corporation | 2012-01-25 | Traditional | PDF ↗ |
| K113381 | MYSONO U6 DIAGNOSTIC ULTRASOUND SYSTEM | Samsung Medison Co., Ltd. | 2011-12-29 | Traditional | PDF ↗ |
| K113690 | GE LOGIQ I, LOGIQ E AND VIVID E | GE Healthcare | 2011-12-29 | Special | PDF ↗ |
| K112997 | HD-IVUS ULTRASOUND IMAGING SYSTEM | Silicon Vally Medical Instruments, Inc. | 2011-12-17 | Traditional | PDF ↗ |
| K100919 | PRO FOCUS 2202, PRO FOCUS 2202 UV MODEL: TYPE 2202 | B-K Medical Aps | 2011-12-16 | Traditional | PDF ↗ |
| K113647 | DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S DIAGNOSTIC ULTRASOUND SYSTEM | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2011-12-16 | Traditional | PDF ↗ |
| K113179 | ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2011-12-07 | Traditional | PDF ↗ |
| K112602 | S6 DIAGNOSTIC ULTRASOUND SYSTEM | Sonoscape Company Limited | 2011-11-07 | Traditional | PDF ↗ |
| K112646 | SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM | Samsung Medison Co., Ltd. | 2011-10-12 | Traditional | PDF ↗ |
| K110870 | APLIO DIAGNOSTIC ULTRASOUND SYSTEM; APLIO DIAGNOSTIC ULTRASOUND SYSTEM; APLIO DIAGNOSTIC ULTRASOUND SYSTEM | Toshiba America Medical Systems, In.C | 2011-10-04 | Traditional | PDF ↗ |
| K112371 | LOGIQ P3 | GE Healthcare | 2011-09-27 | Traditional | PDF ↗ |
| K110673 | HI VISION ASCENDUS DIAGNOSTIC ULTRASOUND SCANNER | Hitachi Medical Systems America, Inc. | 2011-09-27 | Traditional | PDF ↗ |
| K112726 | SONIX ULTRASOUND SCANNER | Ultrasonix Medical Corporation | 2011-09-27 | Traditional | PDF ↗ |
| K112122 | VENUE 40 | GE Healthcare | 2011-09-23 | Traditional | PDF ↗ |
| K112596 | ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2011-09-16 | Traditional | PDF ↗ |
| K112451 | S8 DIAGNOSTIC ULTRASOUND SYSTEM | Sonoscape Company Limited | 2011-09-16 | Special | PDF ↗ |
| K112213 | VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM | GE Healthcare | 2011-09-01 | Traditional | PDF ↗ |
| K112339 | ACCUVIX A30 DIAGNOSTIC ULTRASOUND SYSTEM | Samsung Medison Co., Ltd. | 2011-08-29 | Traditional | PDF ↗ |
| K111582 | LOGIQ S8 | GE Healthcare | 2011-07-26 | Traditional | PDF ↗ |
Product code IYN · Class II · Radiology. Data: openFDA.