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 3 of 9
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K102027 | AXIS NANO OPTHALMIC BIOMETER ULTRASOUND SYSTEM | Quantel Medical S.A. | 2010-12-22 | Traditional | PDF ↗ |
| K102198 | COMPACT TOUCH STS | Quantel Medical S.A. | 2010-11-05 | Traditional | PDF ↗ |
| K102393 | VIVID S5 DIAGNOSTIC ULTRASOUND SYSTEM; VIVID S6 DIAGNOSTICULTRASOUND SYSTEM | Ge Medical System Israel , Ltd. | 2010-11-05 | Special | PDF ↗ |
| K102991 | M5 DIAGNOSTIC ULTRASOUND SYSTEM | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2010-10-22 | Traditional | PDF ↗ |
| K101149 | GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM | Ge Vingmed Ultrasound AS | 2010-10-13 | Special | PDF ↗ |
| K101337 | A6 PORTABLE ULTRASONIC DIAGNOSTIC SYSTEM | Sonoscape Company Limited | 2010-09-30 | Traditional | PDF ↗ |
| K101429 | ECO SUPERGEL | Ceracarta Spa | 2010-09-15 | Traditional | PDF ↗ |
| K093466 | HI VISION PREIRUS DOAGNOSTIC ULTRASOUND SCANNER MODEL HI VISION PREIRUS | Hitachi Medical Systems America, Inc. | 2010-06-17 | Traditional | PDF ↗ |
| K100363 | ULTRA DCI MODEL 5000 | Ultrasound Medical Devices, Inc. | 2010-05-21 | Traditional | PDF ↗ |
| K094038 | COMPACT TOUCH | Quantel S.A. | 2010-04-22 | Traditional | PDF ↗ |
| K100252 | MASTER-VU A-SCAN, MV4500 | Sonomed, Inc. | 2010-04-09 | Traditional | PDF ↗ |
| K093371 | MODEL DGH 6000 SCANMATE A | Dgh Technology, Inc. | 2010-04-05 | Traditional | PDF ↗ |
| K093485 | VESISCAN | Life-Tech, Inc. | 2010-03-16 | Traditional | PDF ↗ |
| K100079 | DIGITAL ULTRASOUND SCANNER | Shenzhen Well.D Medical Electronics Co., Ltd. | 2010-03-01 | Traditional | PDF ↗ |
| K092837 | OTI-SCAN 3000 | Opko Instrumentation, Inc. | 2009-12-23 | Special | PDF ↗ |
| K093488 | ALOKA PROSOUND ALPHA 6 DIAGNOSTIC ULTRASOUND SYSTEM | Aloka Co., Ltd. | 2009-11-20 | Traditional | PDF ↗ |
| K092619 | ETRAX NEEDLE SYSTEM, ETRAX VARIABLE ANGLE NEEDLE GUIDANCE SYSTEM, VIRTUTRAX UNIVERSAL TRACKER | Civco | 2009-11-13 | Traditional | PDF ↗ |
| K092182 | VOYAGER COMPACT IMAGING SYSTEM | Ardent Sound, Inc. | 2009-10-09 | Traditional | PDF ↗ |
| K090773 | CFI ULTRASOUND PROBE DRAPE | Contour Fabricators, Inc. | 2009-09-18 | Traditional | PDF ↗ |
| K092140 | GE VIVID I DIAGNOSTIC ULTRASOUND, GE VIVID Q DIAGNOSTIC ULTRASOUND | Ge Medical Systems Israel, Ultrasound, Ltd. | 2009-08-21 | Special | PDF ↗ |
| K083728 | INVISION SYSTEM | Inneroptic Technology, Inc. | 2009-08-12 | Traditional | PDF ↗ |
| K091518 | CUBESCAN BIOCON-500 DIAGNOSTIC ULTRASOUND SYSTEM | Mcube Technology Co., Ltd. | 2009-06-18 | Traditional | PDF ↗ |
| K091374 | GE LOGIQ I/E & VIVID E COMPACT ULTRASOUND | Ge Medical Systems China Co., Ltd. | 2009-05-26 | Traditional | PDF ↗ |
| K090505 | SPEQ ULTRASOUND SYSTEM | Signostics Pty, Ltd. | 2009-05-07 | Traditional | PDF ↗ |
| K090059 | IMAGO C21 DIAGNOSTIC ULTRASOUND SYSTEM | Saset (Chengdu), Inc. | 2009-04-30 | Traditional | PDF ↗ |
| K090214 | VERATHON INC. BLADDERSCAN BVM 9500 ULTRASOUND | Verathon Incorporated | 2009-03-13 | Abbreviated | PDF ↗ |
| K083061 | ELLEX INNOVATIVE IMAGING EYE CUBED V4 | Ellex, Inc. | 2009-01-09 | Abbreviated | PDF ↗ |
| K081148 | SIEMENS ACUSON 2000 ULTRASOUND SYSTEM WITH ABVS TRANSDUCER | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2008-12-22 | Traditional | PDF ↗ |
| K082456 | VERATHON INC. BLADDERSCAN ULTRASOUND SYSTEM, MODEL BVI 9600 | Verathon Incorporated | 2008-12-01 | Abbreviated | PDF ↗ |
| K082543 | SONOCINE ADJUNCTIVE BREAST ULTRASOUND SYSTEM (ABU), MODEL 100 | Sonocine, Inc. | 2008-10-14 | Traditional | PDF ↗ |
| K082229 | S5/S5I SERIES INTRAVASCULAR IMAGING AND PRESSURE SYSTEM, COMBOMAP PRESSURE AND FLOW SYSTEM | Volcano Corporation | 2008-10-08 | Special | PDF ↗ |
| K082185 | GE LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS 5205000, 5205000-2 | Ge Medical Systems Ultrasound and Primary Care Dia | 2008-08-15 | Special | PDF ↗ |
| K080930 | MODIFICATION TO AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS | U-System, Inc. | 2008-08-07 | Traditional | PDF ↗ |
| K081873 | EMP-2100 FULL DIGITAL ULTRASOUND DIAGNOSTIC DEVICE | Shenzhen Emperor Electronic Technology Co. , Ltd. | 2008-07-16 | Traditional | PDF ↗ |
| K081781 | NUWAV | Laborie Medical Technologies, Corp. | 2008-07-09 | Traditional | PDF ↗ |
| K080223 | ZURA TEE SYSTEM | Imacor, LLC | 2008-06-24 | Traditional | PDF ↗ |
| K081121 | MODIFICATION TO ACUSON X150 ULTRASOUND SYSTEM | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2008-06-04 | Traditional | PDF ↗ |
| K081154 | ULTRASOUND SCANNER FLEX FOCUS, MODEL 1202 | B-K Medical Aps | 2008-05-23 | Special | PDF ↗ |
| K081110 | SIUI CTS-900 DIGITAL ULTRASOUND IMAGING SYSTEM | Shantou Institute of Ultrasonic Instuments | 2008-05-16 | Special | PDF ↗ |
| K080234 | TERASON ECHO T/3000 ULTRASOUND SYSTEM WITH STRESS ECHO | Teratech Corp. | 2008-02-14 | Traditional | PDF ↗ |
| K080049 | VASCUVIEW ULTRASOUND SYSTEM | Escalon Medical Corp. | 2008-01-23 | Traditional | PDF ↗ |
| K073196 | MASTER-VU | Sonomed, Inc. | 2007-12-19 | Special | PDF ↗ |
| K072676 | ACUSON X300 ULTRASOUND SYSTEM | Siemens Medical Solutions USA, Inc. | 2007-12-18 | Special | PDF ↗ |
| K072797 | GE LOGIQ I COMAPACT ULTRASOUND, GE LOGIQ E COMPACT ULTRASOUND, GE VIVID E COMPACT ULTRASOUND | General Electric Co. | 2007-10-17 | Special | PDF ↗ |
| K072517 | ILAB ULTRASOUND IMAGING SYSTEM, VERSION 1.3 | Boston Scientific Corp | 2007-09-26 | Special | PDF ↗ |
| K072210 | CHISON, MODEL 8300 | Chison Medical Imaging Co., Ltd. | 2007-08-24 | Traditional | PDF ↗ |
| K071996 | MYLAB30, MODEL 7300 | Esaote, S.p.A. | 2007-08-03 | Traditional | PDF ↗ |
| K071156 | SOUNMED SD-2000 PLUS PORTABLE ULTRASOUND SCANNER | Sounmed, Inc. | 2007-07-03 | Traditional | PDF ↗ |
| K071314 | SONOLINE G20 DIAGNOSTIC ULTRASOUND SYSTEMS | Siemens Medical Solutions USA, Inc. | 2007-05-22 | Traditional | PDF ↗ |
| K071204 | SITE-RITE 6 ULTRASOUND SYSTEM, MODEL SITE-RITE 6 | C.R. Bard, Inc. | 2007-05-18 | Special | PDF ↗ |
| K071217 | BLADDERSCAN BVI 9400 ULTRASOUND | Verathon Incorporated | 2007-05-17 | Traditional | PDF ↗ |
| K071134 | SONOSITE MAXX SERIES DIAGNOSTIC ULTRASOUND SYSTEM | Sonosite,Inc. | 2007-05-08 | Traditional | PDF ↗ |
| K070982 | CTS-7700 DIGITAL ULTRASOUND IMAGING SYSTEM | Shantou Institute of Ultrasonic Instuments | 2007-05-02 | Traditional | PDF ↗ |
| K070943 | B-SCAN PLUS | Accutome Ultrasound, Inc. | 2007-04-19 | Traditional | PDF ↗ |
| K070907 | INTERSON USB ULTRASOUND PROBE SYSTEM | Regulatory Management Services | 2007-04-17 | Traditional | PDF ↗ |
| K070884 | POD B-SCAN | Starfish Product Engineering, Inc. | 2007-04-11 | Traditional | PDF ↗ |
| K070526 | DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2007-03-23 | Special | PDF ↗ |
| K070477 | ORISON EMBRACE SYSTEM | Orison Corporation | 2007-03-09 | Traditional | PDF ↗ |
| K070077 | ULTRASOUND SCANNER PROFOCUS, MODEL 2202 | B-K Medical Aps | 2007-03-05 | Traditional | PDF ↗ |
| K063472 | ULTRASONIC BIOMETER/ PACHYMETER FOR OPHTHALMOLOGY, MODEL ODM 2100, 2200 | Meda , Ltd. | 2007-01-31 | Traditional | PDF ↗ |
| K063433 | ULTRASONIC BIOMETER/PACHYMETER FOR OPTHALMOLOGY ODM 2100 AND ODM 2200 | Meda , Ltd. | 2007-01-29 | Traditional | PDF ↗ |
| K062571 | LONGPORT EPISCAN, MODEL-I-200 | Longport, Inc. | 2006-11-21 | Traditional | PDF ↗ |
| K063085 | MODIFICATION TO ACUSON SEQUOIA ULTRASOUND SYSTEM | Siemens Medical Solutions USA, Inc. | 2006-11-14 | Special | PDF ↗ |
| K061215 | VOLCANO S51 FAMILY OF IMAGING SYSTEMS | Volcano Corporation | 2006-08-10 | Special | PDF ↗ |
| K061755 | MYLAB15/20 NEW INDICATIONS ULTRASOUND SYSTEM | Esaote Europe B.V. | 2006-08-07 | Traditional | PDF ↗ |
| K061641 | ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SARANO | Shimadzu Medical Systems | 2006-07-14 | Traditional | PDF ↗ |
| K061682 | GE VOLUSON E8 ULTRASOUND SYSTEM | General Electric Co. | 2006-07-12 | Special | PDF ↗ |
| K060483 | VOLCANO ANGIO-IVUS MAPPING (AIM) SYSTEM | Volcano Corporation | 2006-06-23 | Traditional | PDF ↗ |
| K061083 | CTS-7700 | Shantou Institute of Ultrasonic Instuments | 2006-06-06 | Traditional | PDF ↗ |
| K061189 | DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006-06-01 | Special | PDF ↗ |
| K060949 | DP-6600 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006-05-04 | Special | PDF ↗ |
| K053306 | IVIEW | Ondemandsoft | 2006-04-19 | Traditional | PDF ↗ |
| K060626 | VUMAX | Sonomed, Inc. | 2006-04-11 | Special | PDF ↗ |
| K060800 | SEEKER/SPARK ULTRASOUND SYSTEM | Ardent Sound, Inc. | 2006-04-07 | Traditional | PDF ↗ |
| K053346 | MODIFICATION TO: DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL DP-9900 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2005-12-09 | Special | PDF ↗ |
| K053325 | MEDIWATCH MULTISCAN ULTRASOUND SYSTEM/SCANNER, MODEL M0002 (SCANNER ONLY); MULTISCAN ULTRASOUND SYSTEM, MODEL M0001 | Mediwatch, Ltd. | 2005-12-07 | Abbreviated | PDF ↗ |
| K052348 | IN VISION GOLD WITH SPIN VISION, MODEL 891 SV | Volcano Corporation | 2005-12-02 | Traditional | PDF ↗ |
| K052355 | AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS | U-Systems, Inc. | 2005-09-14 | Special | PDF ↗ |
| K051920 | VOLCANO S5 IMAGING SYSTEM, MODEL 804200-001 | Volcano Corporation | 2005-08-19 | Special | PDF ↗ |
| K052113 | DP-6600 ULTRASONIC DIAGNOSTIC IMAGING SYSTEM | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2005-08-09 | Traditional | PDF ↗ |
| K051851 | AVISO OPHTHALMIC ULTRASOUND SYSTEM | Quantel Medical | 2005-08-03 | Special | PDF ↗ |
| K051500 | FAMIO DIAGNOSTIC ULTRASOUND SYSTEMS, MODEL SSA-530A | Toshiba America Medical Systems, In.C | 2005-06-17 | Traditional | PDF ↗ |
| K051304 | ISCIENCE SURGICAL OPHTHALMIC IMAGING SYSTEM | Science Surgical Corporation | 2005-06-03 | Traditional | PDF ↗ |
| K050980 | ULTRASONIC BIO-MICROSCOPE, MODEL P60 | Paradigm Medical Industries, Inc. | 2005-05-26 | Traditional | PDF ↗ |
| K050552 | PACHPEN PACHYMETER, MODEL 24-5100 | Accutome, Inc. | 2005-03-28 | Traditional | PDF ↗ |
| K050551 | VOYAGER PERSONAL IMAGING DEVICE | Ardent Sound, Inc. | 2005-03-22 | Traditional | PDF ↗ |
| K043189 | SONALIS, MODEL 2000 | 3g Ultrasound, Inc. | 2005-02-09 | Abbreviated | PDF ↗ |
| K050167 | CHISON 600M WITH C60 CONVEX PROBE, L700 LINEAR PROBE | Chison Medical Imaging Co., Ltd. | 2005-02-08 | Traditional | PDF ↗ |
| K043563 | DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2005-01-11 | Traditional | PDF ↗ |
| K042620 | SONATA 3-D IMAGING ACCESSORY, MODEL 3DS | Tetrad Corp. | 2004-12-23 | Traditional | PDF ↗ |
| K043287 | PALMSCAN AP2000; PALMSCAN A2000; PALMSCAN P2000 | Micromedical Devices, Inc. | 2004-12-10 | Traditional | PDF ↗ |
| K043275 | OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CENTER | Olympus Medical Systems Corporation | 2004-12-09 | Traditional | PDF ↗ |
| K043078 | NEMIO DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-550A | Toshiba America Medical Systems, In.C | 2004-11-17 | Traditional | PDF ↗ |
| K042250 | SENSATOUCH | Aluna Management Co., Ltd. | 2004-11-12 | Traditional | PDF ↗ |
| K042188 | VOLCANO THERAPEUTICS, INC. VOLCANO IVUS SYSTEM | Volcano Therapeutics, Inc. | 2004-11-10 | Traditional | PDF ↗ |
| K042752 | ACCUPACH V | Accutome Ultrasound, Inc. | 2004-11-10 | Traditional | PDF ↗ |
| K042831 | ATP (AUTO NON-CONTACT TONOMETER/PACHYMETER) | Reichert, Inc. | 2004-10-28 | Traditional | PDF ↗ |
| K042833 | SONOLINE G20 DIAGNOSTIC ULTRASOUND SYSTEMS | Siemens Medical Solutions USA, Inc. | 2004-10-27 | Traditional | PDF ↗ |
| K042540 | PHILIPS IU22 ULTRASOUND SYSTEM | Philips Ultrasound, Inc. | 2004-10-04 | Traditional | PDF ↗ |
| K041639 | TARGETSCN TRANSRECTAL ULTRASOUND SYSTEM | Envisioneering, LLC | 2004-09-02 | Traditional | PDF ↗ |
Product code IYO · Class II · Radiology. Data: openFDA.