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 9 of 12
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K111302 | MYLABSEVEN, MYLABALPHA | Esaote, S.p.A. | 2011-07-22 | Traditional | PDF ↗ |
| K110943 | LOGIQ E9 | GE Healthcare | 2011-07-22 | Traditional | PDF ↗ |
| K111864 | E-CUBE 9 | Alpinion Medical Systems Co., Ltd. | 2011-07-15 | Traditional | PDF ↗ |
| K111674 | ACUSON | Siemens Medical Solutions USA, Inc. | 2011-06-30 | Traditional | PDF ↗ |
| K102813 | EZONO 3000 | Life-Tech, Inc. | 2011-06-30 | Traditional | PDF ↗ |
| K111513 | CX50 DIAGNOSTIC ULTRASOUND SYSTEM | Philips Ultrasound, Inc. | 2011-06-24 | Traditional | PDF ↗ |
| K110510 | S20 DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM | Sonoscape Company Limited | 2011-05-16 | Traditional | PDF ↗ |
| K111227 | ALOKA SSD-3500 DIAGNOSTIC ULTRASOUND SYSTEM | Aloka Co., Ltd. | 2011-05-13 | Traditional | PDF ↗ |
| K110841 | DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX / LINEAR / PHASED ARRAY TRANSDUCER | Shantou Institute of Ultrasonic Instruments (Siui | 2011-04-15 | Special | PDF ↗ |
| K110482 | PROSOUND C3 / C3 CV ULTRASOUND SYSTEMS | Teratech Corp. | 2011-03-18 | Traditional | PDF ↗ |
| K103471 | UBM PLUS | Accutome, Inc. | 2011-03-14 | Traditional | PDF ↗ |
| K103649 | VOLUSON S6, VOLUSON S8 | GE Healthcare | 2011-03-09 | Traditional | PDF ↗ |
| K102642 | SONOSCAPE ULTRASOUND SYSTEM AND TRANSDUCERS MODEL SSI-8000, 2P1 PHASED ARRAY, 5P1 PHASED ARRAY MODEL 2P1, 5P1, 6V1 MICRO | Sonoscape Company Limited | 2011-03-04 | Traditional | PDF ↗ |
| K103397 | ACCUVIX XG DIAGNOSTIC ULTRASOUND SYSTEM | Medison Co., Ltd. | 2011-02-25 | Traditional | PDF ↗ |
| K110207 | ALOKA PROUSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM | Aloka Co., Ltd. | 2011-02-17 | Traditional | PDF ↗ |
| K101236 | VOLUSON E6/E8/E8 EXPERT DIAGNOSTIC ULTRASOUND SYSTEM MODEL: H48681BD/ H48681BX/ H48681BM | GE Healthcare | 2011-02-08 | Traditional | PDF ↗ |
| K110199 | DC-T6 DIAGNOSTIC ULTRASOUND SYSTEM | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2011-02-08 | Traditional | PDF ↗ |
| K101312 | NUVUE COLORMARK9TM) NEEDLE | Nuvue Therapeutics, Inc. | 2011-02-04 | Traditional | PDF ↗ |
| K103677 | M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2011-01-31 | Traditional | PDF ↗ |
| K103144 | DIGITAL COLOR DOPPLER ULTRASOUND IMAGAING SYSTEM; CONVEX / LINEAR PHASED ARRAY TRANSDUCER | Shantou Institute of Ultrasonic Instruments (Siui | 2011-01-12 | Traditional | PDF ↗ |
| K103152 | 6250 ULTRASOUND SYTEMS | Esaote, S.p.A. | 2011-01-07 | Traditional | PDF ↗ |
| K103583 | DC-7 DIAGNOSTIC ULTRASOUND SYSTEM | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2010-12-27 | Traditional | PDF ↗ |
| K102997 | SONIXTABLET ULTRASOUND SCANNER | Ultrasonix Medical Corporation | 2010-12-21 | Traditional | PDF ↗ |
| K102989 | OPUS DIAGNOSTIC ULTRASOUND SYSTEM & TRANSDUCERS | Chang Gung Medical Technology Co., Ltd. Linkou Fac | 2010-12-09 | Traditional | PDF ↗ |
| K100598 | PENRITH ELETTRA ULTRASOUND SYSTEM | Penrith Corporation | 2010-11-19 | Traditional | PDF ↗ |
| K102390 | SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM | Sonosite,Inc. | 2010-11-19 | Traditional | PDF ↗ |
| K102388 | VIVID I DIAGNOSTIC ULTRASOUND SYSTEM | Ge Medical System Israel , Ltd. | 2010-11-04 | Special | PDF ↗ |
| K102901 | HI VISION AVIUS DIAGNOSTIC ULTRASOUND SCANNER | Hitachi Medical Systems America, Inc. | 2010-10-27 | Special | PDF ↗ |
| K102023 | DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, MODEL APOGEE 3500, CONVEX ARRAY TRANSDUCER, MODEL C3L60C | Shantou Institute of Ultrasonic Instruments (Siui | 2010-10-19 | Traditional | PDF ↗ |
| K101874 | GE LOGIQ P6/P6 PRO | GE Healthcare | 2010-10-05 | Special | PDF ↗ |
| K102256 | GE LOGIQ I/E & VIVID E COMPACT DIAGNOSTIC ULTRASOUND | Ge Medical Systems China Co., Ltd. | 2010-10-05 | Traditional | PDF ↗ |
| K102104 | GE VIVID P3 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM | Wipro GE Healthcare Private, Ltd. | 2010-10-01 | Special | PDF ↗ |
| K102017 | SC2000 DIAGNOSTIC ULTRASOUND SYSTEM | Siemens Medical Solutions USA, Inc. | 2010-09-20 | Traditional | PDF ↗ |
| K101605 | MYLABONE ULTRASOUND SYSTEM | Esaote Europe B.V. | 2010-08-31 | Traditional | PDF ↗ |
| K101878 | GE LOGIQ P5 MODEL H44662LD | GE Healthcare | 2010-08-31 | Special | PDF ↗ |
| K102113 | GE VENUE 40 COMPACT DIAGNOSTIC ULTRASOUND | Ge Medical Systems China Co., Ltd. | 2010-08-12 | Traditional | PDF ↗ |
| K102065 | SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM | Medison Co., Ltd. | 2010-08-06 | Traditional | PDF ↗ |
| K101455 | EKO 7 DIAGNOSTIC ULTRASOUND SYSTEM | Medison Co., Ltd. | 2010-07-19 | Traditional | PDF ↗ |
| K100931 | MYLABTWICE, MODEL 6200 | Esaote, S.p.A. | 2010-06-25 | Traditional | PDF ↗ |
| K101091 | Z.ONE ULTRA ULTRASOUND SYSTEM | Zonare Medical Systems, Inc. | 2010-06-25 | Traditional | PDF ↗ |
| K100989 | ZURA TEE SYSTEM WITH CLARITEE PROBE | Imacor, Inc. | 2010-06-25 | Traditional | PDF ↗ |
| K093395 | OLYMPUS GF TYPE UC180, OLYMPUS GF TYPE UCT180 EVIS EXERA II ULATRASOUND GASTROVIDEOSCOPE | Olympus Medical Systems Corporation | 2010-06-17 | Traditional | PDF ↗ |
| K100830 | M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2010-05-05 | Traditional | PDF ↗ |
| K100186 | MYSONO U5 DIAGNOSTIC ULTRASOUND SYSTEM | Medison Co., Ltd. | 2010-03-24 | Traditional | PDF ↗ |
| K092922 | SSI-8000/S8/S6 DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM, 2P1 PHASED ARRAY DIAGNOSTIC ULTRASOUND TRANSDUCER | Sonoscape Company Limited | 2010-03-12 | Traditional | PDF ↗ |
| K092907 | DIGITAL ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY TRANSDUCER, CONVEX ARRAY TRANSDUCER, PHASED ARR | Shantou Institute of Ultrasonic Instuments | 2010-03-05 | Traditional | PDF ↗ |
| K100402 | SITE-RITE VISION ULTRASOUND SYSTEM | Bard Access Systems, Inc. | 2010-03-05 | Traditional | PDF ↗ |
| K093812 | ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM | Siemens Medical Solutions USA, Inc. | 2010-03-03 | Traditional | PDF ↗ |
| K093563 | IU22 ULTRASOUND SYSTEM AND TRANSDUCERS | Philips Ultrasound, Inc. | 2010-02-01 | Traditional | PDF ↗ |
| K093849 | ACCUVIX V10 DIAGNOSTIC ULTRASOUND SYSTEM | Medison Co., Ltd. | 2010-01-19 | Traditional | PDF ↗ |
| K093613 | VASCUVIEW TAP ULTRASOUND SYSTEM | Escalon Medical Corp. | 2009-12-23 | Traditional | PDF ↗ |
| K093171 | VIAMO SSA-640A VERSION 1.2 | Toshiba America Medical Systems, In.C | 2009-12-04 | Traditional | PDF ↗ |
| K093531 | ACUSON MODEL X300 DIAGNOSTIC ULTRASOUND SYSTEM | Siemens Medi Cal Solutions, Inc. | 2009-12-01 | Traditional | PDF ↗ |
| K092271 | GE LOGIQ E9 BT2010 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL 5205000-3, 5205000-4 | GE Healthcare | 2009-11-17 | Traditional | PDF ↗ |
| K092948 | APLIO MX SSA-780A, VERSION 1.0 | Toshiba America Medical Systems, In.C | 2009-10-09 | Traditional | PDF ↗ |
| K092058 | SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM | Sonosite,Inc. | 2009-10-02 | Traditional | PDF ↗ |
| K091970 | AIXPLORER ULTRASOUND SYSTEM | Supersonic Imagine | 2009-08-12 | Traditional | PDF ↗ |
| K092079 | MODIFICATION TO GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND | Ge Medical Systems Israel, Ultrasound, Ltd. | 2009-08-06 | Special | PDF ↗ |
| K092179 | APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A VERSION 4.0R001 | Toshiba America Medical Systems, In.C | 2009-07-29 | Traditional | PDF ↗ |
| K092159 | ACCUVIX V20 DIAGNOSTIC ULTRASOUND SYSTEM | Medison Co., Ltd. | 2009-07-28 | Traditional | PDF ↗ |
| K091009 | MY LABS25 GOLD/MYLAB30 GOLD CARDIOVASCULAR MODEL 7340, MY LAB70/MY LAB70XVISION/MYLAB60, MODEL 6150 | Esaote, S.p.A. | 2009-05-18 | Traditional | PDF ↗ |
| K091164 | GE VENUE 40, MODEL 5324338 | Ge Medical Systems China Co., Ltd. | 2009-05-05 | Traditional | PDF ↗ |
| K090743 | YIELD MINI DOPPLER SYSTEM | Broncus Technologies, Inc. | 2009-04-03 | Traditional | PDF ↗ |
| K083114 | ACUSON P50 ULTRASOUND SYSTEM | Siemens Medical Solutions USA, Inc. | 2009-03-31 | Special | PDF ↗ |
| K090229 | DIAGNOSTIC DOPPLER ULTRASOUND SYSTEM 2-5MHZ CURVED LINEAR ARRAY, 5-10MHZ LINEAR ARRAY, 2-4MHZ PHASE ARRAY, 4-8MHZ TRANSV | Chang Gung Medical Supplies & Equipment Corp. | 2009-03-13 | Traditional | PDF ↗ |
| K090334 | ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM | Siemens Medi Cal Solutions, Inc. | 2009-02-20 | Traditional | PDF ↗ |
| K090158 | APLIO ARTIDA V2.0 SSH-880CV | Toshiba America Medical Systems, In.C | 2009-02-06 | Traditional | PDF ↗ |
| K083882 | MYLABFIVE | Esaote Europe B.V. | 2009-01-30 | Traditional | PDF ↗ |
| K083254 | ALOKA PROUSOUND 2 DIAGNOSTIC ULTRASOUND SYSTEM | Aloka Co., Ltd. | 2008-12-19 | Traditional | PDF ↗ |
| K083505 | DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008-12-12 | Traditional | PDF ↗ |
| K082142 | ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2008-11-13 | Traditional | PDF ↗ |
| K083095 | SONIXTOUCH ULTRASOUND SYSTEM | Ultrasonix Medical Corporation | 2008-10-31 | Traditional | PDF ↗ |
| K083001 | M5 DIAGNOSTIC ULTRASOUND SYSTEM | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008-10-22 | Traditional | PDF ↗ |
| K082326 | ZONARE ULTRA ULTRASOUND SYSTEM | Zonare Medical Systems, Inc. | 2008-10-08 | Traditional | PDF ↗ |
| K082656 | MODEL FF SONIC US-750 XT DIAGNOSTIC ULTRASOUND SYSTEM 3D IMAGING UNIT | Fukuda Denshi USA, Inc. | 2008-09-30 | Traditional | PDF ↗ |
| K081386 | MODEL 6150 (MYLAB70) AND MODEL 6100 (MYLAB90) | Esaote, S.p.A. | 2008-09-25 | Traditional | PDF ↗ |
| K082374 | VIVID I AND VIVID Q | Ge Medical Systems Israel, Ultrasound, Ltd. | 2008-09-02 | Traditional | PDF ↗ |
| K082098 | SONOSITE MAXX SERIES ULTRASOUND SYSTEM | Sonosite,Inc. | 2008-08-25 | Traditional | PDF ↗ |
| K082119 | APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A VERSION 3.0 | Toshiba America Medical Systems, In.C | 2008-08-12 | Traditional | PDF ↗ |
| K080935 | SONIX MDP ULTRASOUND SCANNER | Ultrasonix Medical Corporation | 2008-08-06 | Traditional | PDF ↗ |
| K081921 | GE VIVID E9 ULTRASOUND | General Electric Co. | 2008-08-06 | Special | PDF ↗ |
| K081794 | MODEL 7340 ULTRASOUND SYSTEM | Esaote, S.p.A. | 2008-07-10 | Traditional | PDF ↗ |
| K081676 | SONOACE X6 DIAGNOSTIC ULTRASOUND SYSTEM | Medison Co., Ltd. | 2008-07-02 | Traditional | PDF ↗ |
| K081661 | HD15 DIAGNOSTIC ULTRASOUND SYSTEM | Philips Ultrasound, Inc. | 2008-06-24 | Traditional | PDF ↗ |
| K081065 | APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A, VERSION 2.2 | Toshiba America Medical Systems, In.C | 2008-06-06 | Traditional | PDF ↗ |
| K081320 | DC-3, DC-3T DIAGNOSTIC ULTRASOUND SYSTEM | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008-05-27 | Traditional | PDF ↗ |
| K080760 | ACUSON X300 ULTRASOUND SYSTEM | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2008-04-25 | Special | PDF ↗ |
| K080800 | ACCUVIX V20 DIAGNOSTIC ULTRASOUND SYSTEM | Medison Co., Ltd. | 2008-04-07 | Traditional | PDF ↗ |
| K080548 | HD7 DIAGNOSTIC ULTRASOUND SYSTEM | Phillips Medical Systems | 2008-03-27 | Traditional | PDF ↗ |
| K080640 | M5 DIAGNOSTIC ULTRASOUND SYSTEM | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008-03-21 | Traditional | PDF ↗ |
| K073709 | MODIFICATION TO VIEWMATE SYSTEM | Ep Medsystems | 2008-03-11 | Special | PDF ↗ |
| K080176 | ALOKA PROSOUND 6 DIAGNOSTIC ULTRASOUND SYSTEM | Aloka Co., Ltd. | 2008-02-29 | Traditional | PDF ↗ |
| K080160 | APLIO ARTIDA, MODEL SSH-880CV DIAGNOSTIC ULTRASOUND SYSTEM | Toshiba America Medical Systems, In.C | 2008-02-08 | Traditional | PDF ↗ |
| K073408 | GE LOGIQ BT08 DIAGNOSTIC ULTRASOUND SYSTEM | Ge Medical Systems Ultrasound and Primary Care Dia | 2007-12-19 | Special | PDF ↗ |
| K073297 | GE LOGIQ P6 | General Electric Co. | 2007-12-18 | Special | PDF ↗ |
| K072365 | SEQUOIA PLUS DIAGNOSTIC ULTRASOUND SYSTEM | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007-10-17 | Traditional | PDF ↗ |
| K072090 | SIEMENS DIAGNOSTIC ULTRASOUND SYSTEMS | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007-09-14 | Special | PDF ↗ |
| K072075 | MODIFICATION TO GE LOGIQ A3 | General Electric Co. | 2007-08-29 | Special | PDF ↗ |
| K071985 | GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND | General Electric Co. | 2007-08-17 | Special | PDF ↗ |
| K072000 | APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-790A VERSION 2.0 | Toshiba America Medical Systems, In.C | 2007-07-30 | Traditional | PDF ↗ |
Product code IYN · Class II · Radiology. Data: openFDA.