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 11 of 12
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K031066 | VIEWMATE ULTRASOUND IMAGING SYSTEM | Ep Medsystems | 2003-10-17 | Traditional | PDF ↗ |
| K033196 | SONOLINE ANTARES WITH CLARIFY VE | Siemens Medical Solutions USA, Inc. | 2003-10-16 | Traditional | PDF ↗ |
| K032620 | GE VOLUSON 730 PRO/EXPERT BT03 ULTRASOUND SYSTEM | General Electric Co. | 2003-10-10 | Special | PDF ↗ |
| K032503 | EUB-5500 DIAGNOSTIC ULTRASOUND SCANNER | Hitachi Medical Systems America, Inc. | 2003-08-22 | Special | PDF ↗ |
| K032329 | SA 9900 PLUS DIAGNOSTIC ULTRASOUND SYSTEM | Medison America, Inc. | 2003-08-06 | Traditional | PDF ↗ |
| K032281 | SSA-770A - VERSION 4, APLIO DIAGNOSTIC ULTRASOUND SYSTEM | Toshiba America Medical Systems, In.C | 2003-08-06 | Traditional | PDF ↗ |
| K032182 | GE LOGIQ 7, MODEL 2354858 | General Electric Co. | 2003-07-25 | Special | PDF ↗ |
| K032114 | SEQUOIA 8.0 DIAGNOSTIC ULTRASOUND SYSTEM | Siemens Medical Solutions USA, Inc. | 2003-07-21 | Traditional | PDF ↗ |
| K032111 | ACUSON CV70 CARDIOVASCULAR SYSTEM | Siemens Medical Solutions USA, Inc. | 2003-07-18 | Traditional | PDF ↗ |
| K031663 | GE VIVID 7, MODEL FC0003XX | General Electric Co. | 2003-06-09 | Special | PDF ↗ |
| K031552 | MYCOLOR 202 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS | Medison America, Inc. | 2003-05-30 | Traditional | PDF ↗ |
| K020754 | NICOLET PIONEER TC8080 | Nicolet Biomedical | 2003-04-21 | Abbreviated | PDF ↗ |
| K030934 | GE LOGIQ 9 MODEL 2375600 | Ge Medical Systems, Inc. | 2003-04-17 | Special | PDF ↗ |
| K030949 | TITAN HIGH RESOLUTION ULTRASOUND SYSTEM | Sonosite,Inc. | 2003-04-07 | Traditional | PDF ↗ |
| K030455 | BORIS PLATFORM DIAGNOSTIC ULTRASOUND SYSTEM | Philips Ultrasound, Inc. | 2003-03-13 | Traditional | PDF ↗ |
| K023255 | TECHNOS MP, MODEL AU6 | Biosound Esaote, Inc. | 2003-02-11 | Traditional | PDF ↗ |
| K030191 | TERASON MODEL 2000/BAS PORTABLE ULTRASOUND SYSTEM | Teratech Corp. | 2003-01-29 | Traditional | PDF ↗ |
| K023512 | PICUS ULTRASOUND IMAGING SYSTEMS | Pie Medical | 2003-01-24 | Traditional | PDF ↗ |
| K024236 | ULTRASOUND SCANNER, TYPE 2400 | B-K Medical A/S | 2003-01-17 | Special | PDF ↗ |
| K022517 | USI-2000 ULTRASOUND SYSTEM WITH AUTOMATED SCANNING ACCESSORY | U-Systems, Inc. | 2002-12-24 | Traditional | PDF ↗ |
| K023996 | ALOKA SSD-3500 ULTRASOUND SYSTEM | Aloka Co., Ltd. | 2002-12-18 | Traditional | PDF ↗ |
| K023957 | SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (C2 SERIES) | Sonosite,Inc. | 2002-12-12 | Traditional | PDF ↗ |
| K023720 | SONOLINE ANTARES ULTRASOUND SYSTEM | Siemens Medical Solutions USA, Inc. | 2002-11-20 | Traditional | PDF ↗ |
| K022858 | SUPERNOVA DIAGNOSTIC ULTRASOUND SCANNING SYSTEM | Novasonics, Inc. | 2002-09-06 | Traditional | PDF ↗ |
| K022567 | SEQUOIA SIGNATURE II DIAGNOSTIC ULTRASOUND SYSTEM | Acuson Corp. | 2002-08-13 | Traditional | PDF ↗ |
| K022400 | SSA-700A, APLIO DIAGNOSTIC ULTRASOUND SYSTEM | Toshiba America Medical Systems, In.C | 2002-08-06 | Traditional | PDF ↗ |
| K022303 | PHILIPS M2424 DIAGNOSTIC ULTRASOUND SYSTEM &PHILIPS 21315 DIAGNOSTIC ULTRASOUND TRANSDUCER | Philips Ultrasound, Inc. | 2002-07-30 | Traditional | PDF ↗ |
| K021497 | CYPRESS ULTRASOUND SYSTEM | Acuson Corp. | 2002-07-09 | Special | PDF ↗ |
| K021984 | PUNCTSURE ULTRASOUND VASCULAR IMAGING SYSTEM; PUNCTURESURE VASCULAR IMAGING PROCEDURE KIT | Inceptio Medical Technologies, LC | 2002-07-02 | Abbreviated | PDF ↗ |
| K020630 | ULTRASONIX ERGOSONIX 500 ULTRASOUND SCANNER | Ultrasonix Medical Corporation | 2002-06-13 | Traditional | PDF ↗ |
| K013902 | U-SYSTEMS DIAGNOSTIC ULTRASOUND SYSTEM USI-2000 | U-Systems, Inc. | 2002-06-05 | Traditional | PDF ↗ |
| K021628 | SONOSITE HAND-CARIED UNTRASOUND SYSTEM (POWERSERIES) | Sonosite,Inc. | 2002-05-31 | Traditional | PDF ↗ |
| K014168 | AU6 (TECHNOS/TECHNOS MP) ULTRASOUND IMAGING SYSTEM (ADDITION OF 3D IMAGING MODE AND MUSCULOSKELETAL INDICATION) | Biosound Esaote, Inc. | 2002-04-25 | Traditional | PDF ↗ |
| K013848 | U-SYSTEMS DIAGNOSTIC ULTRASOUND SYSTEM U-2000 | U-Systems, Inc. | 2002-04-08 | Traditional | PDF ↗ |
| K020789 | GE VIVID 3 EXPERT; GE VIVID 3 PRO | General Electric Co. | 2002-04-04 | Traditional | PDF ↗ |
| K020353 | OMNIA X/XS ULTRASOUND SYSTEM | Siemens Medical Systems, Inc. | 2002-02-13 | Traditional | PDF ↗ |
| K013722 | MODIFICATION TO: EUB-8500 DIAGNOSTIC ULTRASOUND SCANNER | Hitachi Medical Corp. | 2002-02-11 | Special | PDF ↗ |
| K020263 | LOGIQ 3 | General Electric Co. | 2002-02-06 | Special | PDF ↗ |
| K014097 | GE LOGIQ 5 | GE Medical Systems | 2002-01-10 | Special | PDF ↗ |
| K014191 | M2540 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL M2540 | Philips Medical Systems | 2002-01-07 | Traditional | PDF ↗ |
| K014116 | HAND-CARRIED ULTRASOUND SYSTEM | Sonosite,Inc. | 2001-12-20 | Traditional | PDF ↗ |
| K013627 | SONOACE SA-8000 DIAGNOSTIC ULTRASOUND SYSTEM | Medison America, Inc. | 2001-11-16 | Traditional | PDF ↗ |
| K012867 | SONOACE 9900 DIAGNOSTIC ULTRASOUND SYSTEM | Medison America, Inc. | 2001-09-12 | Traditional | PDF ↗ |
| K012080 | SSD-5000 DIAGNOSTIC ULTRASOUND SYSTEM | Aloka Co., Ltd. | 2001-08-29 | Abbreviated | PDF ↗ |
| K012239 | MODIFICATIONS TO EUB-525 DIAGNOSTIC ULTRASOUND SCANNER; EUB-2000 DIAGNOSTIC ULTRASOUND SCANNER; SP-711 SONOPROBE SYSTEM | Hitachi Medical Corp. | 2001-08-10 | Traditional | PDF ↗ |
| K012369 | BASIC, MODELS BASIC 1, BASIC 2, AND BASIC 3 | Atys Medical | 2001-08-10 | Traditional | PDF ↗ |
| K012191 | TERATECH MODEL 2000 HANDHELD ULTRASOUND SYSTEM WITH DOPPLER AND HARMONIC IMAGING MODES | Teratech Corp. | 2001-07-26 | Traditional | PDF ↗ |
| K011457 | ALOKA SSD-5500 WITH KI AND A-SMA | Aloka Co., Ltd. | 2001-05-23 | Traditional | PDF ↗ |
| K011188 | GE LOGIQ 9, MODEL 2188900-X | GE Medical Systems | 2001-05-18 | Special | PDF ↗ |
| K011315 | SSD 5500 WITH OLYMPUS GF TYPE UC140P-AL5 | Aloka Co., Ltd. | 2001-05-15 | Traditional | PDF ↗ |
| K011224 | HDI 5000 ULTRASOUND SYSTEM WITH ASSISTED BORDER DETECTION (ABD), XRES IMAGING, AND PANORAMIC MEASUREMENT CAPABILITY | Advanced Technology Laboratories, Inc. | 2001-05-04 | Traditional | PDF ↗ |
| K003986 | ULTRASOUND SCANNER TYPE 2102 | B-K Medical A/S | 2001-04-03 | Traditional | PDF ↗ |
| K010649 | EXHALE DOPPLER SYSTEM | Broncus Technologies, Inc. | 2001-03-20 | Traditional | PDF ↗ |
| K010631 | NEMIO | Toshiba America Medical Systems, In.C | 2001-03-15 | Traditional | PDF ↗ |
| K010405 | 7230 ULTRASOUND IMAGING SYSTEM WITH TEI | Biosound Esaote, Inc. | 2001-03-13 | Traditional | PDF ↗ |
| K010329 | LOGIQ 500 | General Electric Co. | 2001-03-01 | Special | PDF ↗ |
| K010374 | SONOSITE HAND-CARRIED ULTRASOUND SYSTEM | Sonosite,Inc. | 2001-02-21 | Traditional | PDF ↗ |
| K003515 | ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200 | Shimadzu Medical Systems | 2001-02-12 | Traditional | PDF ↗ |
| K003514 | ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200 | Shimadzu Medical Systems | 2001-02-12 | Traditional | PDF ↗ |
| K003931 | VIVID 7 WITH SONOPAC, MODEL FB0008XX | Ge Medical Systems, Inc. | 2001-01-18 | Special | PDF ↗ |
| K003479 | U-SYSTEMS ULTRASOUND SYSTEM USI-2000 | U-Systems, Inc. | 2001-01-18 | Traditional | PDF ↗ |
| K003739 | ALOKA SSD-4000 | Aloka Co., Ltd. | 2000-12-27 | Abbreviated | PDF ↗ |
| K003525 | VOLUSON 730 DIAGNOSTIC ULTRASOUND SYSTEM | Medison America, Inc. | 2000-11-22 | Traditional | PDF ↗ |
| K003399 | SONOSITE HAND-CARRIED ULTRASOUND SYSTEM | Sonosite,Inc. | 2000-11-16 | Traditional | PDF ↗ |
| K002880 | 300LC ULTRASOUND IMAGING SYSTEMS, MODEL 300LC | Pie Medical | 2000-10-26 | Traditional | PDF ↗ |
| K003125 | SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM | Siemens Medical Solutions USA, Inc. | 2000-10-20 | Traditional | PDF ↗ |
| K002470 | M2424A SONOS 5500/4500 DIAGNOSTIC ULTRASOUND SYSTEM, VERSION B.2. 21330A TRANSDUCER | Agilent Technologies, Inc. | 2000-09-08 | Traditional | PDF ↗ |
| K002533 | TCD 100M, PWD13 TRANSDUCER | Spencer Technologies | 2000-08-30 | Traditional | PDF ↗ |
| K002491 | COMBISON 301 PW ULTRASOUND SYSTEM AND TRANSDUCERS | Medison Co., Ltd. | 2000-08-25 | Traditional | PDF ↗ |
| K002397 | M2430 DIAGNOSTIC ULTRASOUND SYSTEM WITH THE 21420 TRANSDUCER | Agilent Technologies, Inc. | 2000-08-17 | Traditional | PDF ↗ |
| K002239 | SIGMA 110/330 DIAGNOSTIC ULTRASOUND SYSTEM | Kontron Medical Systems Sas | 2000-08-08 | Traditional | PDF ↗ |
| K001400 | ELEGRA MILLENNIUM ENHANCED DIAGNOSTIC ULTRASOUND SYSTEM | Siemens Medical Solutions USA, Inc. | 2000-08-01 | Traditional | PDF ↗ |
| K002185 | SONOACE SA 9900 DIAGNOSTIC ULTRASOUND SYSTEM | Medison America, Inc. | 2000-08-01 | Traditional | PDF ↗ |
| K990517 | EXPLORER CVS TRANSCRANIAL DOPPLER | Diagnostic Medical Systems | 2000-08-01 | Traditional | PDF ↗ |
| K002003 | HDI 5000 ULTRASOUND SYSTEM WITH EXTENDED FIELD OF VIEW IMAGING | Atl Ultrasound, Inc. | 2000-07-13 | Traditional | PDF ↗ |
| K993939 | NICOLET EME LEGEND TC22 | Nicolet Biomedical | 2000-06-29 | Traditional | PDF ↗ |
| K001711 | M2410B IMAGEPOINT HX MULTISPECIALTY SYSTEM, VERSION B.1 | Agilent Technologies, Inc. | 2000-06-20 | Traditional | PDF ↗ |
| K000931 | AU5 ULTRASOUND IMAGING SYSTEM | Biosound Esaote, Inc. | 2000-06-08 | Traditional | PDF ↗ |
| K001267 | GE SYSTEM FIVE | Ge Medical Systems, Inc. | 2000-05-12 | Special | PDF ↗ |
| K000415 | OIS-2500 DIAGNOSTIC ULTRASOUND SYSTEM | Optimal Imaging Systems, Inc. | 2000-04-11 | Traditional | PDF ↗ |
| K994026 | EUB-6000 ULTRASOUND DIAGNOSTIC SCANNER | Hitachi Medical Corp. of America | 2000-03-29 | Traditional | PDF ↗ |
| K994369 | 7250 (MEGAS) | Biosound Esaote, Inc. | 2000-02-24 | Traditional | PDF ↗ |
| K000034 | OIS-STAND ALONE DIAGNOSTIC ULTRASOUND SYSTEM | Optimal Imaging Systems, Inc. | 2000-02-24 | Traditional | PDF ↗ |
| K994096 | SONOHEART HAND-CARRIED ECHOCARDIOGRAPHY SYSTEM | Sonosite,Inc. | 1999-12-20 | Traditional | PDF ↗ |
| K984203 | SIUI APOGEE 800PLUS ULTRASOUND IMAGING SYSTEM | Shantou Institute of Ultrasonic Instuments | 1999-11-01 | Traditional | PDF ↗ |
| K992663 | ALOKA SSD-5500 DIAGNOSTIC ULTRASOUND SYSTEM | Aloka Co., Ltd. | 1999-08-24 | Traditional | PDF ↗ |
| K991805 | ASPEN ULTRASOUND WITH FREESTYLE IMAGING OPTION | Acuson Corp. | 1999-08-02 | Traditional | PDF ↗ |
| K991872 | LYNX ULTRASOUND SYSTEM | Ecton, Inc. | 1999-06-16 | Traditional | PDF ↗ |
| K991858 | SSA-390A/POWER VISION 8000 | Toshiba America Medical Systems, In.C | 1999-06-16 | Traditional | PDF ↗ |
| K990360 | AU6 | Biosound Esaote, Inc. | 1999-04-30 | Traditional | PDF ↗ |
| K990970 | SONOACE 6000C DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS, ALSO CALLED ULTRASOUND SYSTEM AND TRANSDUCERS | Medison America, Inc. | 1999-04-07 | Traditional | PDF ↗ |
| K990806 | C1 ULTRASOUND SYSTEM | Sonosite,Inc. | 1999-03-26 | Traditional | PDF ↗ |
| K990339 | SONOS 5500 IMAGING SYSTEM M2424A VERSION B.O | Hewlett-Packard Co. | 1999-02-18 | Traditional | PDF ↗ |
| K984307 | MODIFICATION OF: RHEO DOPPLEX II | Huntleigh Healthcare, Inc. | 1999-01-12 | Traditional | PDF ↗ |
| K974813 | COMBISON 530D WITH POWER DOPPLER MODE | Medison America, Inc. | 1998-09-29 | Traditional | PDF ↗ |
| K981834 | PERCEPTION INC, GPS-6TBMD DIAGNOSTIC ULTRASOUND SYSTEM | Perception, Inc. | 1998-09-29 | Traditional | PDF ↗ |
| K980468 | AU5 ULTRASOUND IMAGING SYSTEM | Biosound Esaote, Inc. | 1998-08-26 | Traditional | PDF ↗ |
| K974269 | SA8800 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS, | Medison America, Inc. | 1998-08-21 | Traditional | PDF ↗ |
| K974588 | INTRA-VIEW BILATERAL TRANSCRANIAL DOPPLER DEVICE, SMART-LITE PORTABLE BILATERAL TRANSCRANIAL DOPPLER DEVICE, COMPACT MOD | Rimed , Ltd. | 1998-08-07 | Traditional | PDF ↗ |
| K982498 | DIAGNOSTIC ULTRASOUND SYSTEM | Volumetrics Medical Imaging, Inc. | 1998-08-07 | Traditional | PDF ↗ |
Product code IYN · Class II · Radiology. Data: openFDA.