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 7 of 12
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K152164 | S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound System | Sonoscape Medical Corp. | 2015-08-28 | Special | PDF ↗ |
| K152165 | S9 Portable Digital Color Doppler Ultrasound System | Sonoscape Medical Corp. | 2015-08-26 | Special | PDF ↗ |
| K152209 | FUJIFILM SonoSite X-Porte Ultrasound System | FUJIFILM Sonosite, Inc. | 2015-08-19 | Traditional | PDF ↗ |
| K151663 | RS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2015-08-12 | Traditional | PDF ↗ |
| K150861 | QBit Series Diagnostic Ultrasound System | Chison Medical Imaging Co., Ltd. | 2015-07-28 | Traditional | PDF ↗ |
| K141720 | iuStar300 Medical Ultrasound Diagnostic System | United Imaging Systems (Beijing) Co., Ltd. | 2015-07-23 | Traditional | PDF ↗ |
| K150773 | E-CUBE 15 Diagnostic Ultrasound System | Alpinion Medical Systems Co., Ltd. | 2015-07-23 | Traditional | PDF ↗ |
| K151451 | Aplio 500/400/300 Diagnostic Ultrasound System V6.0 | Toshibamedical Systems Corporation | 2015-07-09 | Traditional | PDF ↗ |
| K143476 | Digi-One | Rimed , Ltd. | 2015-06-23 | Special | PDF ↗ |
| K150002 | iNSIGHT Color Doppler Ultrasound System | Saset (Chengdu), Inc. | 2015-06-23 | Traditional | PDF ↗ |
| K151028 | LOGIQ e | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2015-06-18 | Traditional | PDF ↗ |
| K150080 | DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015-06-12 | Special | PDF ↗ |
| K150628 | VentriPoint Medical System | Ventripoint, Inc. | 2015-05-22 | Traditional | PDF ↗ |
| K151175 | ZONARE ZS3 Diagnostic Ultrasound System | Zonare Medical Systems, Inc. | 2015-05-15 | Special | PDF ↗ |
| K150533 | Terason uSmart3200T Ultrasound System | Teratech Corp. | 2015-05-09 | Traditional | PDF ↗ |
| K150045 | S30/S40 Digital Color Doppler Ultraound System | Sonoscape Company Limited | 2015-04-28 | Traditional | PDF ↗ |
| K150204 | DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound Systems | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015-04-10 | Traditional | PDF ↗ |
| K150478 | A35 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2015-03-26 | Traditional | PDF ↗ |
| K143601 | U-Lite | Sonoscanner Sarl | 2015-03-18 | Traditional | PDF ↗ |
| K150249 | ZONARE ZS3 and Z.Onepro Diagnostic Ultrasound System | Zonare Medical Systems, Inc. | 2015-03-04 | Traditional | PDF ↗ |
| K150087 | Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging System, Vivid E95 Diagnostic Ultrasound Imaging System | Ge Vingmed Ultrasound AS | 2015-03-04 | Traditional | PDF ↗ |
| K150148 | Terason uSmart3300 Ultrasound System | Teratech Corp. | 2015-02-20 | Traditional | PDF ↗ |
| K142511 | U50 Diagnostic Ultrasound System | Edan Instruments, Inc. | 2015-02-20 | Traditional | PDF ↗ |
| K142472 | Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound Systems | GE Healthcare | 2015-02-10 | Traditional | PDF ↗ |
| K150050 | ACUSON P500 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2015-02-09 | Traditional | PDF ↗ |
| K143452 | LOGIQ P9, LOGIQ P7 | GE Healthcare | 2015-01-29 | Traditional | PDF ↗ |
| K142714 | S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound System | Sonoscape Company Limited | 2015-01-29 | Traditional | PDF ↗ |
| K142815 | S22 Digital Color Doppler Ultrasound System | Sonoscape Company Limited | 2015-01-28 | Traditional | PDF ↗ |
| K143298 | Ultrasound Scanner System bk2300 | Bk Medical Aps | 2015-01-16 | Abbreviated | PDF ↗ |
| K142368 | NOBLUS DIAGNOSTIC ULTRASOUND SCANNER | Hitachi Aloka Medical, Ltd. | 2015-01-14 | Traditional | PDF ↗ |
| K142710 | S9 Portable Digital Color Doppler Ultrasound System | Sonoscape Company Limited | 2015-01-05 | Traditional | PDF ↗ |
| K143472 | TE7 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015-01-02 | Traditional | PDF ↗ |
| K142474 | S12 Digital Color Doppler Ultrasound System | Sonoscape Company Limited | 2014-12-19 | Traditional | PDF ↗ |
| K143264 | H60 V2.00 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2014-12-09 | Traditional | PDF ↗ |
| K143089 | WS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2014-11-26 | Traditional | PDF ↗ |
| K142197 | ULTRASOUND SYSTEM SONIMAGE HS1, LINEAR PROBE L18-4, CONVEX PROBE C5-2 | Konica Minolta, Inc. | 2014-11-21 | Traditional | PDF ↗ |
| K142100 | AIXPLORER | Supersonic Imagine | 2014-11-20 | Traditional | PDF ↗ |
| K143027 | Xario 200, V3.0 | Toshibamedical Systems Corporation | 2014-11-20 | Traditional | PDF ↗ |
| K143046 | Xario 100, V3.0 | Toshibamedical Systems Corporation | 2014-11-19 | Traditional | PDF ↗ |
| K141462 | VARIA-NCI | Neurochaos Solutions, Inc. | 2014-11-19 | Traditional | PDF ↗ |
| K131973 | UNEXEF-38G ULTRASOUND SYSTEM | Toyota Tsusho Corporation | 2014-11-18 | Traditional | PDF ↗ |
| K142733 | E-CUBE 5 | Alpinion Medical Systems Co., Ltd. | 2014-10-28 | Traditional | PDF ↗ |
| K141459 | APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM, V5.0 | Toshibamedical Systems Corporation | 2014-10-28 | Traditional | PDF ↗ |
| K142884 | E-CUBE 12 | Alpinion Medical Systems Co., Ltd. | 2014-10-28 | Traditional | PDF ↗ |
| K142876 | ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc. | 2014-10-23 | Traditional | PDF ↗ |
| K142323 | Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound System | Ge Medical Systems Israel , Ltd. | 2014-10-10 | Traditional | PDF ↗ |
| K142160 | LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM | GE Healthcare | 2014-10-10 | Traditional | PDF ↗ |
| K142628 | Acuson SC2000 Diagnostic Ultrasound System | Siemens Medi Cal Solutions, Inc. | 2014-10-10 | Traditional | PDF ↗ |
| K142466 | UGEO PT60A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2014-10-03 | Traditional | PDF ↗ |
| K142008 | MYLABSEVEN, MYLABALPHA | Esaote, S.p.A. | 2014-09-12 | Traditional | PDF ↗ |
| K142077 | MYLABGAMMA | Esaote, S.p.A. | 2014-09-12 | Traditional | PDF ↗ |
| K142017 | X-PORTE ULTRASOUND SYSTEM | FUJIFILM Sonosite, Inc. | 2014-08-22 | Traditional | PDF ↗ |
| K141870 | BREAST VOLUME NAVIGATOR | Metritrack, LLC | 2014-08-07 | Traditional | PDF ↗ |
| K141846 | ACUSON X700 ULTRASOUND SYSTEM, ACUSON X600 ULTRASOUND SYSTEM | Siemens Medical Solutions USA, Inc. | 2014-08-07 | Traditional | PDF ↗ |
| K141768 | LOGIQ V5/LOGIQ V3 | GE Healthcare | 2014-08-04 | Traditional | PDF ↗ |
| K141675 | VOLUSON P6, VOLUSON P8 | GE Healthcare | 2014-07-25 | Special | PDF ↗ |
| K141641 | ZONARE ZS3 DIAGNOSTIC ULTRASOUND SYSTEM | Zonare Medical Systems, Inc. | 2014-07-18 | Traditional | PDF ↗ |
| K141639 | VOLUSON S6, VOLUSON S8 | GE Healthcare | 2014-07-18 | Special | PDF ↗ |
| K141486 | MYLABSIX ULTRASOUND SYSTEM | Esaote Europe B.V. | 2014-07-11 | Traditional | PDF ↗ |
| K141369 | VISIQ DIAGNOSTIC ULTRA SOUND SYSTEM | Philips Ultrasound, Inc. | 2014-07-02 | Traditional | PDF ↗ |
| K141620 | RS80A DIAGNOSTIC ULTRASOUND SYSTEM | Samsung Medison Co., Ltd. | 2014-07-02 | Traditional | PDF ↗ |
| K140443 | ARIETTA 60/ARIETTAS60/ARIETTAV60 | Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical | 2014-06-16 | Traditional | PDF ↗ |
| K141261 | LOGIQ S7 EXPERT, LOGIQ S7 PRO | GE Healthcare | 2014-06-05 | Traditional | PDF ↗ |
| K140364 | CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, PHASED AND CONVEX PROBE, PENCIL AND CONVEX PROBE | Chison Medical Imaging Co., Ltd. | 2014-06-02 | Traditional | PDF ↗ |
| K140773 | TERASON USMART3300 ULTRASOUND SYSTEM | Teratech Corp. | 2014-05-30 | Traditional | PDF ↗ |
| K141067 | VIVID T8/VIVID T8 PRO | GE Healthcare | 2014-05-23 | Traditional | PDF ↗ |
| K140729 | APLIO ARTIDA, V3.2 | Toshiba America Medical Systems, In.C | 2014-05-23 | Traditional | PDF ↗ |
| K140693 | VSCAN WITH DUAL PROBE | Ge Medical Sysyems Ultrasound & Primary Care Diagn | 2014-05-16 | Traditional | PDF ↗ |
| K141010 | M9 DIAGNOSTIC ULTRASOUND SYSTEM, M9T DIAGNOSTIC ULTRASOUND SYSTEM, M9CV DIAGNOSTIC ULTRASOUND SYSTEM | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2014-05-14 | Traditional | PDF ↗ |
| K140959 | ACUSON S1000, S2000, S3000 DIAGNOSTIC ULTRASOUND SYSTEMS | Siemens Medical Solutions USA, Inc. | 2014-04-30 | Traditional | PDF ↗ |
| K140834 | TERASON USMART3400 ULTRASOUND SYSTEM | Teratech Corp. | 2014-04-25 | Traditional | PDF ↗ |
| K140677 | MYLABSSOGNO | Esaote, S.p.A. | 2014-04-25 | Traditional | PDF ↗ |
| K133761 | APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM V4.0 | Toshibamedical Systems Corporation | 2014-04-22 | Traditional | PDF ↗ |
| K140639 | PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM | Hitachi Aloka Medical, Ltd. | 2014-04-16 | Traditional | PDF ↗ |
| K133905 | 6200 / 6250 ULTRASOUND SYSTEM | Esaote, S.p.A. | 2014-04-15 | Traditional | PDF ↗ |
| K134016 | ARIETTA 70/ARIETTA S70/ARIETTA V70 DIAGNOSTIC ULTRASOUND SCANNER | Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical | 2014-03-28 | Traditional | PDF ↗ |
| K140524 | TERASON USMART3200 AND BENQ UP200ULTRASOUND SYSTEM | Teratech Corp. | 2014-03-21 | Traditional | PDF ↗ |
| K140153 | VENTRIPOINT MEDICAL SYSTEM | Ventripoint, Inc. | 2014-03-06 | Traditional | PDF ↗ |
| K140254 | EZONO 4000 | Ezono AG | 2014-02-26 | Traditional | PDF ↗ |
| K132690 | UP600 DIAGNOSTIC DOPPLER ULTRASOUND SYSTEM | Qisda Corporation | 2014-02-25 | Traditional | PDF ↗ |
| K140030 | DC-N3/DC-N3S DIAGNOSTIC ULTRASOUND SYSTEM | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2014-02-19 | Traditional | PDF ↗ |
| K133533 | LOGIQ E | GE Healthcare | 2014-02-12 | Traditional | PDF ↗ |
| K133034 | LOGIQ F SERIES | GE Healthcare | 2014-01-31 | Traditional | PDF ↗ |
| K133277 | XARIO 100 | Toshibamedical Systems Corporation | 2014-01-17 | Traditional | PDF ↗ |
| K133833 | NUVIS DIAGNOSTIC ULTRASOUND SYSTEM | Philips Ultrasound, Inc. | 2014-01-17 | Traditional | PDF ↗ |
| K132335 | ULTRASOUND SCANNER FLEX FOCUS 1202 | B-K Medical Aps | 2014-01-10 | Traditional | PDF ↗ |
| K132677 | ULTRASOUND SCANNER FLEX FOCUS 1202 | B-K Medical Aps | 2014-01-07 | Traditional | PDF ↗ |
| K132685 | ULTRASOUND SCANNER PRO FOCUS 2202 | B-K Medical Aps | 2014-01-06 | Traditional | PDF ↗ |
| K133505 | SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM | Samsung Medison Co., Ltd. | 2013-12-27 | Traditional | PDF ↗ |
| K131164 | ACUSON | Siemens Medical Solutions USA, Inc. | 2013-12-24 | Traditional | PDF ↗ |
| K133431 | VENUE 50 | GE Healthcare | 2013-12-24 | Traditional | PDF ↗ |
| K133454 | SONOSITE EDGE ULTRASOUND SYSTEM | FUJIFILM Sonosite, Inc. | 2013-12-16 | Traditional | PDF ↗ |
| K132466 | MYLABSEVEN 6400, MYLABALPHA 7400 | Esaote, S.p.A. | 2013-12-04 | Traditional | PDF ↗ |
| K132687 | E-CUBE 7 | Alpinion Medical Systems Co., Ltd. | 2013-11-27 | Traditional | PDF ↗ |
| K132231 | MYLABSEVEN, MYLABALPHA | Esaote, S.p.A. | 2013-11-27 | Traditional | PDF ↗ |
| K133329 | UGEO WS80A DIAGNOSTIC ULTRASOUND SYSTEM | Samsung Medison Co., Ltd. | 2013-11-27 | Traditional | PDF ↗ |
| K132779 | DC-N2/DC-N2S DIAGNOSTIC ULTRASOUND SYSTEM | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2013-11-19 | Traditional | PDF ↗ |
| K132527 | DIGITAL COLOR DOPPLER ULTASOUND SYSTEM | Sonoscape Company Limited | 2013-11-14 | Traditional | PDF ↗ |
| K132913 | VOLUSON E6 / E8 / E8EXPERT / E8EXPERT LIMITED EDITION / E10 | GE Healthcare | 2013-11-08 | Special | PDF ↗ |
| K133134 | X-PORTE ULTRASOUND SYSTEM | FUJIFILM Sonosite, Inc. | 2013-11-04 | Traditional | PDF ↗ |
Product code IYN · Class II · Radiology. Data: openFDA.