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 10 of 12
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K071036 | MODIFICATION TO ACUSON X300 ULTRASOUND SYSTEM | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007-05-16 | Special | PDF ↗ |
| K070813 | ACCUVIX V10 DIAGNOSTIC ULTRASOUND SYSTEM | Medison Co., Ltd. | 2007-04-10 | Traditional | PDF ↗ |
| K070576 | ACUSON X150 ULTRASOUND SYSTEM | Siemens Medical Solutions USA, Inc. | 2007-03-26 | Special | PDF ↗ |
| K063683 | OLYMPUS XEU-M60A ENDOSCOPIC ULTRASOUND CENTER; XGF-UM180 ULTRASONIC GASTROVIDEOSCOPE | Olympus Medical Systems Corporation | 2007-02-08 | Traditional | PDF ↗ |
| K063803 | ACUSON ANTARES DIAGNOSTIC ULTRASOUND SYSTEM | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007-01-05 | Traditional | PDF ↗ |
| K063761 | ACUSON P10 DIAGNOSTIC ULTRASOUND SYSTEM | Siemens Medical Solutions USA, Inc. | 2007-01-04 | Traditional | PDF ↗ |
| K063493 | I REVIEW SOFTWARE(ACCESSORY TO) ILAB ULTRASOUND IMAGING SYSTEM) VERSION1.0 | Boston Scientific Corp | 2006-12-21 | Special | PDF ↗ |
| K063518 | HI VISION 900 DIAGNOSTIC ULTRASOUND SCANNER | Hitachi Medical Systems America, Inc. | 2006-12-21 | Special | PDF ↗ |
| K063580 | SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM | Medison Co., Ltd. | 2006-12-14 | Traditional | PDF ↗ |
| K063500 | DC-6 DIAGNOSTIC ULTRASOUND SYSTEM | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006-12-06 | Traditional | PDF ↗ |
| K063138 | MODIFICATION TO ACUSON ANTARES ULTRASOUND SYSTEM | Siemens Medical Solutions USA, Inc. | 2006-11-22 | Special | PDF ↗ |
| K061608 | MODIFICATION TO EUB-5500 DIAGNOSTIC ULTRASOUND SCANNER | Hitachi Medical Corp. | 2006-11-22 | Special | PDF ↗ |
| K060421 | SONARA; SONARA/TEK | Viasys Healthcare, Inc. | 2006-11-03 | Traditional | PDF ↗ |
| K063130 | APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-790A, VERSION 1.0 | Toshibamedical Systems Corporation | 2006-11-02 | Traditional | PDF ↗ |
| K062578 | DIGI-LITE TCD DEVICE | Rimed , Ltd. | 2006-09-18 | Special | PDF ↗ |
| K062247 | HD11 DIAGNOSTIC ULTRASOUND SYSTEM | Philips Ultrasound, Inc. | 2006-08-18 | Special | PDF ↗ |
| K061980 | SIEMENS ACUSON X500 ULTRASOUND SYSTEM | Siemens Medical Solutions USA, Inc. | 2006-08-17 | Special | PDF ↗ |
| K061831 | MEDCHANNEL HTS SYSTEM | Medchannel, LLC | 2006-08-07 | Traditional | PDF ↗ |
| K061827 | SONIX ULTRASOUND SCANNER | Ultrasonix Medical Corporation | 2006-08-04 | Traditional | PDF ↗ |
| K061643 | ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO | Shimadzu Medical Systems | 2006-07-27 | Traditional | PDF ↗ |
| K061637 | ECHOVIEW/ SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200PRO | Shimadzu Medical Systems | 2006-07-25 | Traditional | PDF ↗ |
| K061946 | ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM | Siemens Medical Solutions USA, Inc. | 2006-07-21 | Traditional | PDF ↗ |
| K061525 | GE VIVID - I | General Electric Co. | 2006-07-03 | Special | PDF ↗ |
| K061488 | CTS-5500/CTS-6600 ULTRASONIC PULSED ECHO IMAGING SYSTEM | Shantou Institute of Ultrasonic Instruments (Siui | 2006-06-30 | Special | PDF ↗ |
| K061605 | NEMIO XG, SAA-580A | Toshiba America Medical Systems, In.C | 2006-06-22 | Traditional | PDF ↗ |
| K061437 | SIGMA 5000 SERIES, IMAGIC | Kontron Medical Systems Sas | 2006-06-14 | Traditional | PDF ↗ |
| K061129 | GE LOGIQ 9, MODELS 2188900, 2375600, 2404587 AND 5150000 | General Electric Co. | 2006-06-01 | Special | PDF ↗ |
| K060827 | MYLAB30, 50, 70 AND 90 SYSTEMS ADDITION OF 3D/4D, MODELS 7300, 7350, 6150, 6100 | Esaote, S.p.A. | 2006-05-19 | Traditional | PDF ↗ |
| K061213 | SONOACE PICO DIAGNOSTIC ULTRASOUND SYSTEM | Medison Co., Ltd. | 2006-05-16 | Traditional | PDF ↗ |
| K060112 | NODECREST TRANSCRANICAL DOPPLER ULTRASOUND SYSTEM | Nodecrest, LLC | 2006-05-05 | Traditional | PDF ↗ |
| K060993 | GE LOGIQ P5 AND A5 | General Electric Co. | 2006-05-03 | Special | PDF ↗ |
| K060542 | GE VIVID 7 MODEL FC008XX, GE VIVID 7 MODEL FC009XX | General Electric Co. | 2006-03-31 | Special | PDF ↗ |
| K060087 | ACCUVIX V7 DIAGNOSTIC ULTRASOUND SYSTEM | Medison Co., Ltd. | 2006-01-24 | Traditional | PDF ↗ |
| K053648 | PIONEER TC8080, COMPANION III | Viasys Neuro Care | 2006-01-24 | Abbreviated | PDF ↗ |
| K060059 | ALOKA SD-3500 ULTRASOUND SYSTEM | Aloka Co., Ltd. | 2006-01-13 | Traditional | PDF ↗ |
| K053530 | SONOACE X4 DIAGNOSTIC ULTRASOUND SYSTEM | Medison Co., Ltd. | 2006-01-03 | Traditional | PDF ↗ |
| K053154 | MYLAB15/20 3D/4D ULTRASOUND IMAGING SYSTEM | Pie Medical | 2005-12-16 | Traditional | PDF ↗ |
| K053435 | GE VOLUSON I | General Electric Co. | 2005-12-16 | Special | PDF ↗ |
| K053258 | EUB-6500 DIAGNOSTIC ULTRASOUND SCANNER | Hitachi Medical Corp. | 2005-12-09 | Special | PDF ↗ |
| K052894 | SONOLINE G60 S ULTRASOUND SYSTEM | Siemens Medical Solutions USA, Inc. | 2005-11-23 | Special | PDF ↗ |
| K053069 | SONOSITE MICROMAXX DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES) | Sonosite,Inc. | 2005-11-16 | Traditional | PDF ↗ |
| K053084 | SIGMA 5000 SERIES IMAGIC ULTRASOUND SYSTEM | Kontron Medical Systems Sas | 2005-11-16 | Traditional | PDF ↗ |
| K052331 | ACUSON CYPRESS ULTRASOUND SYSTEM | Siemens Medical Solutions USA, Inc. | 2005-11-10 | Traditional | PDF ↗ |
| K052911 | ACCUVIX XQ DIAGNOSTIC ULTRASOUND SYSTEM | Medison Co., Ltd. | 2005-10-31 | Traditional | PDF ↗ |
| K052805 | MYLAB30, 50 AND 70 SYSTEMS UPGRADE, MODELS 7300, 7350, 6150 | Esaote, S.p.A. | 2005-10-17 | Traditional | PDF ↗ |
| K052410 | ACUSON SEQUOIA ULTRASOUND SYSTEM | Siemens Medical Solutions USA, Inc. | 2005-09-22 | Special | PDF ↗ |
| K052441 | GE LOGIQ 7 ULTRASOUND BT05 | General Electric Co. | 2005-09-21 | Special | PDF ↗ |
| K052109 | SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (C1 SERIES) | Sonosite,Inc. | 2005-08-11 | Traditional | PDF ↗ |
| K052042 | SONOSCAPE SSI-1000/SSI-5000 ULTRASOUND TRANSDUCERS | Sonoscape Company Limited | 2005-08-09 | Traditional | PDF ↗ |
| K051739 | POCKET TRANSCRANIAL AND VASCULAR DOPPLER SPECTRUM ANALYZER, MODEL 500P; PW DOPPLER ULTRAOUND PROBE, MODEL 2MPB. | Multigon Industries, Inc. | 2005-07-28 | Traditional | PDF ↗ |
| K051837 | MYLAB 90 ULTRASOUND IMAGING SYSTEM, MODEL 6100 | Esaote, S.p.A. | 2005-07-20 | Traditional | PDF ↗ |
| K051449 | GE VIVID 7 WITH OR WITHOUT SUFFIX | GE Medical Systems | 2005-06-16 | Special | PDF ↗ |
| K051334 | TERASON ULTRASOUND SYSTEM WITH CONTINUOUS WAVE SOPPLER | Teratech Corp. | 2005-06-03 | Traditional | PDF ↗ |
| K051308 | MYLAB 70 ULTRASOUND IMAGING SYSTEM | Esaote, S.p.A. | 2005-06-01 | Traditional | PDF ↗ |
| K051139 | ACUSON SEQUOIA DIAGNOSTIC ULTRASOUND SYSTEM | Siemens Medical Solutions USA, Inc. | 2005-05-13 | Traditional | PDF ↗ |
| K051085 | DOPPLER-BOX | Compumedics Germany Gmgh | 2005-05-05 | Traditional | PDF ↗ |
| K050510 | ECHOVIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100 | Shimadzu Medical Systems | 2005-04-01 | Traditional | PDF ↗ |
| K050326 | 7350 ULTRASOUND IMAGING SYSTEM, MODEL 7350 | Esaote, S.p.A. | 2005-02-28 | Traditional | PDF ↗ |
| K050380 | XARIO DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-660A | Toshiba America Medical Systems, In.C | 2005-02-23 | Traditional | PDF ↗ |
| K050363 | FUKUDA DENSHI MODEL UF-850XTD | Fukuda Denshi USA, Inc. | 2005-02-17 | Special | PDF ↗ |
| K050240 | MODIFICATION TO ACUSON CV70 CARDIOVASCULAR SYSTEM | Siemens Medical Solutions USA, Inc. | 2005-02-15 | Traditional | PDF ↗ |
| K043139 | USCOM 1A | Uscom, Ltd. | 2005-02-15 | Traditional | PDF ↗ |
| K050126 | GE LOGIQ TWIN | General Electric Co. | 2005-02-02 | Special | PDF ↗ |
| K050099 | SIGMA 5000 SERIES IMAGIC ULTRASOUND SYSTEM | Kontron Medical Systems Sas | 2005-01-28 | Abbreviated | PDF ↗ |
| K043588 | MYLAB 15 / MYLAB 20, MODEL 2700 | Pie Medical | 2005-01-25 | Traditional | PDF ↗ |
| K043554 | ULTRASOUND SCANNER MINI FOCUS, MODEL 1402 | B-K Medical A/S | 2005-01-14 | Special | PDF ↗ |
| K050034 | SONOLINE ANTARES DIAGNOSTIC ULTRASOUND SYSTEM | Siemens Medical Solutions USA, Inc. | 2005-01-13 | Traditional | PDF ↗ |
| K043524 | ULTRASOUND SCANNER PRO FOCUS, MODEL 2202 | B-K Medical A/S | 2005-01-13 | Special | PDF ↗ |
| K043559 | SONOSITE HIGH-RESOLUTION DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES) | Sonosite,Inc. | 2005-01-12 | Traditional | PDF ↗ |
| K043535 | HD11 DIAGNOSTIC ULTRASOUND SYSTEM | Philips Ultrasound, Inc. | 2005-01-06 | Traditional | PDF ↗ |
| K043452 | TITAN HIGH RESOLUTION ULTRASOUND SYSTEM AND SONOSITE ULTRASOUND SYSTEM | Sonosite,Inc. | 2004-12-21 | Traditional | PDF ↗ |
| K043455 | SA8000 SE DIAGNOSTIC ULTRASOUND SYSTEM | Medison Co., Ltd. | 2004-12-21 | Traditional | PDF ↗ |
| K043196 | ALOKA SSD-ALPHA 10 ULTRASOUND SYSTEM | Aloka Co., Ltd. | 2004-11-30 | Traditional | PDF ↗ |
| K043016 | SONOLINE ORCHID DIAGNOSTIC ULTRASOUND SYSTEM | Siemens Medical Solutions USA, Inc. | 2004-11-16 | Traditional | PDF ↗ |
| K042770 | MODIFICATION TO ACUSON CV70 CARDIOVASCULAR SYSTEM | Siemens Medical Solutions USA, Inc. | 2004-10-20 | Traditional | PDF ↗ |
| K042369 | SONOSCAPE ULTRASOUND SYSTEM SSI-1000/SSI-5000 | Sonoscape Company Limited | 2004-10-20 | Traditional | PDF ↗ |
| K042326 | ERGOSONIX ULTRASOUND SCANNER, MODULO ULTRASOUND SCANNER | Ultrasonix Medical Corporation | 2004-09-16 | Traditional | PDF ↗ |
| K042055 | CYPRESS ULTRASOUND SYSTEM | Siemens Medical Solutions USA, Inc. | 2004-08-16 | Special | PDF ↗ |
| K042044 | ACUSON CV70 CARDIOVASCULAR SYSTEM | Siemens Medical Solutions USA, Inc. | 2004-08-13 | Special | PDF ↗ |
| K041915 | HEMO-DOP | Dwl Elektronische Systeme GmbH | 2004-08-04 | Traditional | PDF ↗ |
| K041916 | ALOKA SSD-ALPHA 5 ULTRASOUND SYSTEM | Aloka Co. Ltd USA | 2004-07-30 | Traditional | PDF ↗ |
| K041813 | GE LOGIQ 7 ULTRASOUND BT04 | Ge Medical Systems Ultrasound and Primary Care Dia | 2004-07-23 | Special | PDF ↗ |
| K041675 | PICUS, PARUS, FALCO AND AQUILA ULTRASOUND SYSTEMS | Pie Medical | 2004-07-23 | Traditional | PDF ↗ |
| K041688 | GE VOLUSON 730 PRO/EXPERT UNTRASOUND BT04 | General Electric Co. | 2004-07-08 | Special | PDF ↗ |
| K041552 | GE VIVID 7 BT04 | General Electric Co. | 2004-07-02 | Special | PDF ↗ |
| K040926 | ULTRASOUND SCANNER, HUDSON MODELS 8000 AND 9000 | Hudson Diagnostic Imaging, LLC | 2004-06-10 | Traditional | PDF ↗ |
| K041499 | SSA-770A, APLIO VERSION 5.5 | Toshibamedical Systems Corporation | 2004-06-10 | Traditional | PDF ↗ |
| K041319 | SEQUOIA DIAGNOSTIC ULTRASOUND SYSTEM | Siemens Medical Solutions USA, Inc. | 2004-06-07 | Special | PDF ↗ |
| K040596 | ULTRASOUND IMAGING SYSTEM, MODEL 7300 | Esaote, S.p.A. | 2004-03-31 | Traditional | PDF ↗ |
| K040409 | LARSEN & TOUBRO LIMITED SENORITA COLOR DOPPLER ULTRASOUND SYSTEM | Larsen & Toubro Limited | 2004-02-27 | Traditional | PDF ↗ |
| K040251 | GE LOGIQ 9 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL 2404587 | Ge Med. Systems Ultrasound & Prim. Care Diag.,Llc | 2004-02-20 | Special | PDF ↗ |
| K040060 | SONOLINE G50 AND G60 S DIAGNOSTIC ULTRASOUND SYSTEMS | Siemens Medical Solutions USA, Inc. | 2004-01-28 | Traditional | PDF ↗ |
| K034003 | HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM | Philips Ultrasound, Inc. | 2004-01-08 | Traditional | PDF ↗ |
| K033367 | TITAN ULTRASOUND SYSTEM, SONOSITE ILOOK 25 ULTRASOUND SYSTEM, 180PLUS ULTRASOUND SYSTEM, MODEL L03073, L02245, L02464 | Sonosite,Inc. | 2003-11-05 | Traditional | PDF ↗ |
| K033209 | FUKUDA DENSHI MODEL FF SONIC UF-750XT | Fukuda Denshi USA, Inc. | 2003-10-31 | Traditional | PDF ↗ |
| K032656 | GE LOGIQ 9 ULTRASOUND BT03/IQ, MODEL 2375600-X | Ge Med. Systems Ultrasound & Prim. Care Diag.,Llc | 2003-10-30 | Special | PDF ↗ |
| K033311 | ALOKA SSD-5000 V5.0 ULTRASOUND SYSTEM | Aloka Co., Ltd. | 2003-10-29 | Traditional | PDF ↗ |
| K033139 | GE MARLIN ULTRASOUND | General Electric Co. | 2003-10-23 | Special | PDF ↗ |
| K032477 | GE LOGIQ BOOK | General Electric Co. | 2003-10-22 | Traditional | PDF ↗ |
| K032974 | GE LOGIQ 5 PRO OR EXPERT | General Electric Co. | 2003-10-21 | Special | PDF ↗ |
Product code IYN · Class II · Radiology. Data: openFDA.