FDA Product Code
FDA Product Code IYO — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.1560
510(k) Clearances — 895 records · page 4 of 9
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K041947 | I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND | Innovative Imaging, Inc. | 2004-08-16 | Traditional | PDF ↗ |
| K041455 | SSI-600/SSI-800 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM | Sonoscape Company Limited | 2004-06-10 | Traditional | PDF ↗ |
| K040652 | VUE 100 ULTRASOUND IMAGING SYSTEM | Mobilsonic, Inc. | 2004-05-17 | Traditional | PDF ↗ |
| K040668 | E-Z SCAN AB5500+ | Sonomed, Inc. | 2004-04-13 | Special | PDF ↗ |
| K040719 | ALOKA MODEL SSD-4000 DIAGNOSTIC ULTRASOUND SYSTEM W/OPTIONAL SONOREAL 3D SYSTEM ACCESSORY | Aloka Co., Ltd. | 2004-03-26 | Traditional | PDF ↗ |
| K040502 | SONOLINE EBISU DIAGNOSTIC ULTRASOUND SYSTEMS | Siemens Medical Solutions USA, Inc. | 2004-03-09 | Traditional | PDF ↗ |
| K033906 | PORTASCAN BLADDER SCANNER, MODEL PA00146 | Mediwatch Plc | 2003-12-24 | Traditional | PDF ↗ |
| K033604 | TRINGA ULTRASOUND IMAGING SYSTEM, MODEL 50L | Pie Medical | 2003-12-15 | Traditional | PDF ↗ |
| K033385 | DGH 55 HANDHELD PACHYMETER (PACHMATE) | Dgh Technology, Inc. | 2003-11-07 | Traditional | PDF ↗ |
| K032956 | ACCUSONIC A-SCAN MODEL, 24-4000 | Accutome, Inc. | 2003-10-10 | Traditional | PDF ↗ |
| K032875 | ALOKA MODEL SSD-5500 V6.0 ULTRASOUND SYSTEM | Aloka Co. Ltd USA | 2003-09-30 | Traditional | PDF ↗ |
| K032640 | FULL FIELD BREAST IMAGING (FFBU) DIAGNOSTIC ULTRASOUND SYSTEM | U-Systems, Inc. | 2003-09-11 | Traditional | PDF ↗ |
| K032135 | SITE-RITE IV ULTRASOUND SYSTEM | Dymax Corp | 2003-07-21 | Traditional | PDF ↗ |
| K023430 | UF BRACHYTHERAPY STAND | University of Florida | 2003-06-24 | Traditional | PDF ↗ |
| K031391 | HF MODULE WITH TRANSDUCERS | Ophthalmic Technologies, Inc. | 2003-06-20 | Special | PDF ↗ |
| K030770 | OTI SCAN WITH TRANSDUCERS | Ophthalmic Technologies, Inc. | 2003-03-27 | Special | PDF ↗ |
| K030763 | DIAGNOSTIC ULTRASOUND BLADDERMASS BVM 6500 ULTRASOUND SYSTEM | Diagnostic Ultrasound Corp. | 2003-03-26 | Traditional | PDF ↗ |
| K030610 | POD PAC-20M | Portable Ophthalmic Devices, Inc. | 2003-03-21 | Traditional | PDF ↗ |
| K024114 | A-SCAN 100 | Ophthalmic Technologies, Inc. | 2003-01-10 | Special | PDF ↗ |
| K022928 | HUDSON 2020, 2040, 2060,ULTRASOUND SCANNERS | Hudson Diagnostic Imaging, LLC | 2002-12-11 | Traditional | PDF ↗ |
| K023473 | SONOREAL 3D | Bio Medi Com | 2002-11-20 | Traditional | PDF ↗ |
| K023457 | ULTRASOUND SCANNER, TYPE 1101 | B-K Medical A/S | 2002-11-01 | Traditional | PDF ↗ |
| K021333 | ARTEMIS | Ultralink, LLC | 2002-10-08 | Traditional | PDF ↗ |
| K022153 | BLADDERSCAN BVI 6100 | Diagnostic Ultrasound Corp. | 2002-08-15 | Traditional | PDF ↗ |
| K020668 | ALOKA SSD-1000 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS ASU-1003, UST-9121, UST-9124 | Aloka Co., Ltd. | 2002-07-10 | Abbreviated | PDF ↗ |
| K021683 | CINESCAN S | Quantel Medical | 2002-06-21 | Special | PDF ↗ |
| K020561 | SONO-SCAN, SONO-SCAN PRO, CARDIO SCAN | Tomtec Imaging Systems GmbH | 2002-05-09 | Special | PDF ↗ |
| K020876 | ECHOSCAN, MODEL US-1800 | Nidek, Inc. | 2002-05-03 | Special | PDF ↗ |
| K020112 | 50S TRINGA ULTRASOUND IMAGING SYSTEM | Pie Medical | 2002-04-19 | Traditional | PDF ↗ |
| K020151 | UD-1000 ULTRASONIC A/B SCANNER | Tomey Corp. USA | 2002-04-10 | Traditional | PDF ↗ |
| K012803 | AL-2000 COMBINED BIOMETER AND PACHYMETER | Tomey Corp. | 2002-04-08 | Traditional | PDF ↗ |
| K013088 | ECHOTECH EASY 3D FAMILY, ECHOTECH 3D FREESCAN, ECHOTECH EASYARCHIVE, ECHOTECH QUANTICON, ECHOTECH EASYSTRESS | Echotech 3D Imaging Systems, Inc. | 2002-04-04 | Traditional | PDF ↗ |
| K020068 | SONOREAL 3D SYSTEM | Bio Medi Com | 2002-03-04 | Traditional | PDF ↗ |
| K012727 | HUMPHREY OCT3 | Carl Zeiss Ophthalmic Systems, Inc. | 2002-01-31 | Traditional | PDF ↗ |
| K014206 | LOGIQBOOK | General Electric Co. | 2002-01-16 | Special | PDF ↗ |
| K013327 | CTS-415 | Shantou Institute of Ultrasonic Instuments | 2001-12-14 | Traditional | PDF ↗ |
| K013633 | SSA-770A, APLIO ULTRASOUND SYSTEM | Toshiba America Medical Systems, In.C | 2001-11-13 | Traditional | PDF ↗ |
| K013142 | DIASUS | Dynamic Imaging , Ltd. | 2001-10-05 | Traditional | PDF ↗ |
| K012772 | CTS-485 ULTRASOUND IMAGING SYSTEM | Shantou Institute of Ultrasonic Instuments | 2001-10-01 | Traditional | PDF ↗ |
| K012084 | SONOREAL 3D | Bio Medi Com | 2001-09-26 | Traditional | PDF ↗ |
| K012887 | SA6000II DIAGNOSTIC ULTRASOUND SYSTEM | Medison America, Inc. | 2001-09-12 | Traditional | PDF ↗ |
| K012253 | SSD-1000 DIAGNOSTIC ULTRASOUND SYSTEM | Aloka Co., Ltd. | 2001-08-30 | Abbreviated | PDF ↗ |
| K012560 | GE LOGIQ A100 MP, MODEL 2272413 | General Electric Co. | 2001-08-23 | Special | PDF ↗ |
| K010950 | CYPRESS SYSTEM | Acuson Corp. | 2001-06-27 | Abbreviated | PDF ↗ |
| K011095 | MODEL I0-3DUIMS 3D ULTRASOUND MANAGEMENT SYSTEM | Iodp SA | 2001-06-13 | Traditional | PDF ↗ |
| K011417 | ULTRASOUND SCANNER, TYPE 2102 | B-K Medical A/S | 2001-06-08 | Traditional | PDF ↗ |
| K011252 | EUB-6000 DIAGNOSTIC ULTRASOUND SCANNER SP-711 SONOPROBE SYSTEM | Hitachi Medical Corp. | 2001-05-30 | Traditional | PDF ↗ |
| K003890 | VHF ULTRASONIC ARC-SCAN SYSTEM | Ultralink, LLC | 2001-05-22 | Traditional | PDF ↗ |
| K003725 | 240 PARUS ULTRASOUND IMAGING SYSTEMS, MODEL 240 PARUS | Pie Medical | 2001-03-01 | Traditional | PDF ↗ |
| K003672 | MEDGE PLATFORMS SONOCUBIC 3D ULTRASOUND SOFTWARE | Medge Platforms, Inc. | 2001-02-22 | Traditional | PDF ↗ |
| K003936 | PANORAMIC SCAN, PANORAMIC VIEW, WIDAS, WIDE AREA SCANNING | Tomtec Imaging Systems GmbH | 2001-02-14 | Traditional | PDF ↗ |
| K003041 | ULTRASOUND SCANNER TYPE 2101 | B-K Medical A/S | 2001-02-07 | Traditional | PDF ↗ |
| K003292 | 260 CORVUS | Pie Medical | 2001-01-05 | Traditional | PDF ↗ |
| K003141 | UBM PLUS, MODEL P45 | Paradigm Medical Industries, Inc. | 2000-12-05 | Special | PDF ↗ |
| K002807 | 3D ORGAN ASSESSMENT W/ MAGNETIC POSITION SENSING | Acuson Corp. | 2000-12-01 | Traditional | PDF ↗ |
| K002357 | 100 S AND 100 LC AND 485 ANSER ULTRASOUND IMAGING SYSTEMS | Pie Medical | 2000-11-09 | Traditional | PDF ↗ |
| K003121 | MYSONO 201 DIAGNOSTIC ULTRASOUND AND TRANSDUCERS | Medison America, Inc. | 2000-10-20 | Traditional | PDF ↗ |
| K002085 | ULTRASOUND SCANNER, TYPE 1101 | B & K Medical A/S | 2000-08-01 | Special | PDF ↗ |
| K993674 | POCKET ULTRASONIC PACHYMETER | Quantel Medical | 2000-07-13 | Traditional | PDF ↗ |
| K000960 | BARZELL-WHITMORE MAROON BELLS, INC. COLO-RECTAL MOVER, MODEL 3900 | Barzell-Whitmore Maroon Bells, Inc. | 2000-05-26 | Traditional | PDF ↗ |
| K000681 | AU5, AU6 | Biosound Esaote, Inc. | 2000-05-03 | Traditional | PDF ↗ |
| K000320 | SONOS AIRES 600 (SA-600) | Kpi Ultrasound, LLC | 2000-05-02 | Traditional | PDF ↗ |
| K000516 | GE LOGIQ 700 | Ge Medical Systems, Inc. | 2000-04-19 | Special | PDF ↗ |
| K000571 | GE LOGIQ 700 | GE Medical Systems | 2000-04-18 | Special | PDF ↗ |
| K000695 | GE DOLPHIN DIAGNOSTIC ULTRASOUND SYSTEM, ULTRASONIC PULSED DOPPLER IMAGING SYSTEM | Ge Medical Systems, Inc. | 2000-03-16 | Traditional | PDF ↗ |
| K994385 | BABY FACE | Sonora Medical Systems | 2000-03-16 | Traditional | PDF ↗ |
| K000554 | POCKET ULTRASONIC OPHTHALMIC PACHYMETER, BIOMETRY TRANSDUCER FOR POCKET | Quantel Medical | 2000-03-14 | Special | PDF ↗ |
| K000567 | ULTRASOUND SCANNER TYPE 2102 | B & K Medical A/S | 2000-03-09 | Special | PDF ↗ |
| K993978 | PR3 ULTRASOUND SYSTEM | Carolina Medical, Inc. | 2000-02-10 | Traditional | PDF ↗ |
| K000030 | SONOACE 600 DIAGNOSTIC ULTRASOUND SYSTEM | Medison America, Inc. | 2000-01-19 | Traditional | PDF ↗ |
| K992505 | TERATECH, MODEL 2000 IMAGING IMAGING | Teratech Corp. | 1999-11-10 | Traditional | PDF ↗ |
| K993624 | SITE-RITE 3 ULTRASOUND SYSTEM | Dymax Corp | 1999-11-10 | Traditional | PDF ↗ |
| K993398 | ECHO VIEW, EASY VIEW, OMNI VIEW | Tomtec Imaging Systems GmbH | 1999-11-05 | Special | PDF ↗ |
| K993364 | GE LOGIQ 700 WITH CODED EXCITATION MODIFICATION | Ge Medical Systems, Inc. | 1999-11-05 | Special | PDF ↗ |
| K993394 | ECHO SCAN, EASY SCAN | Tomtec Imaging Systems GmbH | 1999-11-05 | Special | PDF ↗ |
| K993365 | GE LOGIQ 700 WITH HARMONIC IMAGING MODIFICATION | Ge Medical Systems, Inc. | 1999-11-05 | Special | PDF ↗ |
| K993517 | COMBISON 530D/VOLUSON 530D, TISSUE HARMONIC IMAGING (THI) OPTION | Medison America, Inc. | 1999-11-02 | Traditional | PDF ↗ |
| K992580 | FETAL ASSESSMENT CAP | Acuson Corp. | 1999-10-18 | Traditional | PDF ↗ |
| K990401 | FUKUDA DENSHI FF SONIC UF-5800 GENERAL PURPOSE ULTRASOUND SCANNING SYSTEM WITH DOPPLER | Fukuda Denshi USA, Inc. | 1999-10-15 | Traditional | PDF ↗ |
| K992378 | DIAGNOSTIC ULTRASOUND, MODEL 1.0 | Volumetrics Medical Imaging, Inc. | 1999-09-29 | Traditional | PDF ↗ |
| K993069 | GE DIASONICS GATEWAY AND GATEWAY FX | General Electric Co. | 1999-09-22 | Special | PDF ↗ |
| K992761 | SONOACE 5500 DIAGNOSTIC ULTRASOUND SYSTEM | Medison America, Inc. | 1999-09-01 | Traditional | PDF ↗ |
| K992470 | ULTRAMARK 400C/SONOACE 6000 ULTRASOUND SYSTEM | Advanced Technology Laboratories, Inc. | 1999-08-23 | Traditional | PDF ↗ |
| K992046 | SONOLINE 7XX DIAGNOSTIC ULTRASOUND SYSTEM | Siemens Medical Solutions USA, Inc. | 1999-08-13 | Traditional | PDF ↗ |
| K991937 | ULTRASOUND SCANNER, MODEL TYPE 2101 | B & K Medical A/S | 1999-07-30 | Special | PDF ↗ |
| K991469 | AWARE PAD | Aac Consulting Group, Inc. | 1999-07-20 | Traditional | PDF ↗ |
| K992208 | GE LOGIQ 200 MD DIAGNOSTIC ULTRASOUND SYSTEM | Ge Medical Systems, Inc. | 1999-07-12 | Traditional | PDF ↗ |
| K990198 | AMIB7 | Alliance Medical, Inc. | 1999-06-29 | Traditional | PDF ↗ |
| K990238 | LONGPORT MODEL LDS -1 | Longport, Inc. | 1999-06-23 | Traditional | PDF ↗ |
| K991671 | HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM | Advanced Technology Laboratories, Inc. | 1999-06-18 | Traditional | PDF ↗ |
| K991842 | SYSTEM FIVE/ECHOPAC WITH STRAIN RATE IMAGING | Ge Vingmed Ultrasound | 1999-06-11 | Traditional | PDF ↗ |
| K991611 | GE LOGIQ 500 | General Electric Co. | 1999-06-09 | Special | PDF ↗ |
| K991710 | SSA-370A/POWERVISION 6000 | Toshiba America Medical Systems, In.C | 1999-06-03 | Traditional | PDF ↗ |
| K990560 | LIFE IMAGING SYSTEMS, MODEL L3DI | Life Imaging Systems, Inc. | 1999-05-20 | Traditional | PDF ↗ |
| K984161 | CTS-310(B) | Shantou Institute of Ultrasonic Instuments | 1999-05-05 | Traditional | PDF ↗ |
| K990248 | DICOM IMAGE MANAGER, MODEL 3-D VISUALIZATION OPTION | Dicomit Imaging Systems Corp. | 1999-04-16 | Traditional | PDF ↗ |
| K983879 | ALOKA SSD-900 DIAGNOSTIC ULTRASOUND SYSTEM | Aloka Co., Ltd. | 1999-03-22 | Traditional | PDF ↗ |
| K983945 | CORTEX DERMASCAN C ULTRASONIC SYSTEM | Cortex Technology Aps | 1999-03-17 | Traditional | PDF ↗ |
| K984382 | ACCU GUIDE | Tayman Medical, Inc. | 1999-03-05 | Traditional | PDF ↗ |
| K990490 | SSA-320A JUST VISION 200/ SSA-325A JUST VISION | Toshiba America Medical Systems, In.C | 1999-03-02 | Traditional | PDF ↗ |
Product code IYO · Class II · Radiology. Data: openFDA.