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 5 of 9
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K990226 | GE LOGIQ700 DIAGNOSTIC ULTRASOUND SYSTEM WITH B-FLOW | Ge Medical Systems, Inc. | 1999-02-09 | Traditional | PDF ↗ |
| K982840 | BSC SONICATH ULTRA INTRAVASCULAR ULTRASOUND IMAGING WIRE WITH DETACHABLE ADAPTER & BSC SONICATH ULTRA ULTRASOUND IMAGING | Boston Scientific Corp | 1998-11-09 | Traditional | PDF ↗ |
| K981528 | SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM | Siemens Medical Solutions USA, Inc. | 1998-10-28 | Traditional | PDF ↗ |
| K982444 | 7250 ULTRASOUND IMAGING SYSTEM | Biosound Esaote, Inc. | 1998-10-06 | Traditional | PDF ↗ |
| K982800 | ECTON LYNX ULTRASOUND SYSTEM | Ecton, Inc. | 1998-09-22 | Traditional | PDF ↗ |
| K980423 | SONOPSY LA SYSTEM | Neovision Corp. | 1998-08-07 | Traditional | PDF ↗ |
| K974457 | SCOUT 3.2/45 MHZ CORONARY IMAGING CATHETER, SCOUT 3.2/45 MHZ CORONARY IMAGING CATHETER, SCOUT IMAGING CATHETER PATIENT T | Hewlett-Packard Co. | 1998-07-14 | Traditional | PDF ↗ |
| K981293 | 7200 ULTRASOUND IMAGING SYSTEM | Biosound Esaote, Inc. | 1998-06-30 | Traditional | PDF ↗ |
| K965223 | RESOLVE OPTION FOR THE ORACLE IN VISION INTRAVASCULAR ULTRASONIC IMAGING SYSTEM | Endosonics Corp. | 1998-06-29 | Traditional | PDF ↗ |
| K974880 | PERCEPTION GPS-RST DIAGNOSTIC ULTRASOUND SYSTEM | Perception, Inc. | 1998-06-08 | Traditional | PDF ↗ |
| K981626 | SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM | Siemens Medical Solutions USA, Inc. | 1998-05-27 | Traditional | PDF ↗ |
| K980687 | SONOS 5500 ULTRASOUND IMAGING SYSTEM | Hewlett-Packard Co. | 1998-05-22 | Traditional | PDF ↗ |
| K981404 | FUKUDA DENSHI ULTRASOUND SCANNERS MODELS UF-3500 AND UF-4500 | Fukuda Denshi USA, Inc. | 1998-05-20 | Traditional | PDF ↗ |
| K981505 | COZUMEL DIAGNOSTIC ULTRASOUND SYSTEM | Sonosite,Inc. | 1998-05-08 | Traditional | PDF ↗ |
| K981510 | SONOACE 6000/ ULTRAMARK 400 | Medison America, Inc. | 1998-05-08 | Traditional | PDF ↗ |
| K980308 | ECHOTECH 3D FREESCAN | Echotech 3D Imaging Systems GmbH | 1998-05-06 | Traditional | PDF ↗ |
| K980851 | GALAXY INTRAVASCULAR ULTRASOUND SYSTEM, MODEL I5028 | Boston Scientific Corp | 1998-04-22 | Traditional | PDF ↗ |
| K980860 | HDI 1000 DIAGNOSTIC ULTRASOUND SYSTEM | Atlantis Diagnostics Intl., Inc. | 1998-04-02 | Traditional | PDF ↗ |
| K973802 | SHIMASONIC LINEAR/CONVEX DIAGNOSTIC ULTRASOUND SYSTEM | Shimadzu Medical Systems | 1998-03-04 | Traditional | PDF ↗ |
| K974522 | 3D I-SCAN | Ophthalmic Technologies, Inc. | 1998-02-25 | Traditional | PDF ↗ |
| K974432 | ULTRAGUIDE 1000 | Ultraguide , Ltd. | 1998-02-09 | Traditional | PDF ↗ |
| K973767 | HARMONIC IMAGING WITH CONTRAST | Acuson Corp. | 1997-12-23 | Traditional | PDF ↗ |
| K970901 | GE LOGIQ 500 DIAGNOSTIC ULTRASOUND SYSTEM | GE Medical Systems | 1997-12-22 | Traditional | PDF ↗ |
| K972192 | PERCEPTION INC. GPS-XYZ DIAGNOSTIC ULTRASOUND SYSTEM | Perception, Inc. | 1997-12-17 | Traditional | PDF ↗ |
| K971528 | ENDOSCOPICALLY DELIVERALBE ULTRASOUND POINT PORBE SYSTEM (ENDOSCOPY) | Fujinon, Inc. | 1997-12-12 | Traditional | PDF ↗ |
| K973450 | SENSOR PAD | Inventive Products, Inc. | 1997-11-14 | Traditional | PDF ↗ |
| K972973 | PERCEPTION INC. GPS-TUV DIAGNOSTIC ULTRASOUND SYSTEM | Perception, Inc. | 1997-10-15 | Traditional | PDF ↗ |
| K964617 | GE LOGIQ 700 DIAGNOSTIC ULTRASOUND SYSTEM | GE Medical Systems | 1997-10-03 | Traditional | PDF ↗ |
| K963290 | COLORFLO OPTION FOR THE ORACLE INVISION INTRAVASCULAR ULTRASONIC IMAGING SYSTEM | Endosonics Corp. | 1997-08-06 | Traditional | PDF ↗ |
| K970508 | ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM | Shimadzu Medical Systems | 1997-08-04 | Traditional | PDF ↗ |
| K961229 | HR12000 ULTRASOUND SYSTEM | International Ultrasound Corp. | 1997-05-29 | Traditional | PDF ↗ |
| K963065 | CTS-285 WITH EZU-PL21 AND EZU-PC3B TRANSDUCERS | Shantou Institute of Ultrasonic Instuments | 1997-05-29 | Traditional | PDF ↗ |
| K962142 | SONOLINE VERSA 555 DIAGNOSTIC ULTRASOUND SYSTEM | Siemens Medical Solutions USA, Inc. | 1997-05-29 | Traditional | PDF ↗ |
| K963068 | CTS-200 WITH EZU-PL21 TRANSDUCER | Shantou Institute of Ultrasonic Instuments | 1997-05-29 | Traditional | PDF ↗ |
| K962882 | SONOLINE VERSA PRO DIAGNOSTIC ULTRASOUND SYSTEM | Siemens Medical Solutions USA, Inc. | 1997-04-24 | Traditional | PDF ↗ |
| K963863 | JANUS I | 3D Ultrasound, Inc. | 1997-04-21 | Traditional | PDF ↗ |
| K970156 | IMEX FUTURALDOP PRO | Imex Medical Systems, Inc. | 1997-04-04 | Traditional | PDF ↗ |
| K961459 | LEVEL 10 HDI | Advanced Technology Laboratories, Inc. | 1997-03-26 | Traditional | PDF ↗ |
| K963706 | PHILIPS SONO DIAGNOST 800 | Hewlett-Packard Co. | 1997-03-19 | Traditional | PDF ↗ |
| K963315 | VINGMED SOUND COLOR FLOW MAPPING SYSTEM. SYSTEM FIVE | Vingmed Sound, Inc. | 1997-03-17 | Traditional | PDF ↗ |
| K961073 | ATLAS 2.0 & HITACHI 2.0 (A TRADE NAME SUBJECT TO CHANGE) | Atlantis Diagnostics Intl., Inc. | 1997-02-19 | Traditional | PDF ↗ |
| K940942 | COMBISON 530 DIAGNOSTIC ULTRASOUND SCANNER | Medison America, Inc. | 1997-02-19 | Traditional | PDF ↗ |
| K955543 | ULTRASOUND SYSTEM MODEL UF-3500 | Fukuda Denshi USA, Inc. | 1997-02-11 | Traditional | PDF ↗ |
| K962662 | VINGMED SOUND COLOR FLOW MAPPING SYSTEM | Diasonics, Inc. | 1997-01-02 | Traditional | PDF ↗ |
| K963807 | TOMTEC ECHO-SCAN | Tomtec Imaging Systems, Inc. | 1996-12-18 | Traditional | PDF ↗ |
| K963274 | V-LINK 3.2 FOR WINDOWS | Koven Technology, Inc. | 1996-10-31 | Traditional | PDF ↗ |
| K961833 | SONOLINE ELEGRA WITH SIESCAPE FEATURE | Siemens Medical Solutions USA, Inc. | 1996-10-29 | Traditional | PDF ↗ |
| K963585 | BLADDER MANAGER PCI 5000, BLADDERSCAN BVI 5000 | Diagnostic Ultrasound Corp. | 1996-10-01 | Traditional | PDF ↗ |
| K960700 | LOGIQ A200 DIAGNOSTIC ULTRASOUND SYSTEM | GE Medical Systems | 1996-08-28 | Traditional | PDF ↗ |
| K960765 | MENTOR ADVENT A/B SYSTEM | Mentor Ophthalmics, Inc. | 1996-08-08 | Traditional | PDF ↗ |
| K961116 | FIRST BEAT/CARDIO BEAT/CALC | Medasonics, Inc. | 1996-08-08 | Traditional | PDF ↗ |
| K951976 | ECHO. AKHO | Alliance Medical, Inc. | 1996-07-26 | Traditional | PDF ↗ |
| K961029 | KILTEX PROBE COVER | Kiltex Corp. | 1996-07-25 | Traditional | PDF ↗ |
| K962308 | EUB-905 | Hitachi Medical Corp. of America | 1996-07-17 | Traditional | PDF ↗ |
| K954884 | PEDIATRIC MULTIPLANE TRANSESOPHAGEAL PROBE (PMPTE-PROBE), TN100065 | Vingmed Sound, Inc. | 1996-05-28 | Traditional | PDF ↗ |
| K955840 | BLADDERMANAGER PCI 5000 / BLADDERSCAN BVI 5000 | Diagnostic Ultrasound Corp. | 1996-05-24 | Traditional | PDF ↗ |
| K946349 | STENODOC | Specs USA, Inc. | 1996-05-24 | Traditional | PDF ↗ |
| K951449 | MODEL KM-25 | Koven Technology, Inc. | 1996-05-20 | Traditional | PDF ↗ |
| K941593 | DIAGNOSTIC ULTRASONIC TRANSDUCER | Toshiba America Medical Systems, In.C | 1996-05-17 | Traditional | PDF ↗ |
| K960622 | I-SCAN | Ophthalmic Technologies, Inc. | 1996-05-13 | Traditional | PDF ↗ |
| K950330 | DIGITAL IMAGE ACQUISITION SYSTEM | International Imaging Electronics | 1996-05-07 | Traditional | PDF ↗ |
| K951994 | OLYMPUS EU-M30 ENDOSCOPIC ULTRASOUND CENTER | Olympus America, Inc. | 1996-04-15 | Traditional | PDF ↗ |
| K953530 | DIAGNOSTIC ULTRASOUND TRANDUCERS P10A, P12A, PT10A, PA11-A | Biosound, Inc. | 1996-04-08 | Traditional | PDF ↗ |
| K950157 | SIEMENS Q64XXX | Siemens Medical Solutions USA, Inc. | 1996-04-05 | Traditional | PDF ↗ |
| K953752 | RT55 DIAGNOSTIC ULTRASOUND SYSTEM | General Electric Co. | 1996-03-15 | Traditional | PDF ↗ |
| K955942 | BLADDERSCAN BVI 5000 | Diagnostic Ultrasound Corp. | 1996-03-15 | Traditional | PDF ↗ |
| K953773 | 6.5 MHZ ENDORECTAL CONVEX ARRAY (10R) PROBE | Medison America, Inc. | 1996-03-14 | Traditional | PDF ↗ |
| K953673 | ECLIPSE PROBE COVER | Parker Laboratories, Inc. | 1996-03-14 | Traditional | PDF ↗ |
| K952540 | SONOS IMAGING SYSTEM (2000/2500 & 1000/1500) | Hewlett-Packard Co. | 1996-03-11 | Traditional | PDF ↗ |
| K950943 | ULTRA EASE | Lectec Corp. | 1996-03-07 | Traditional | PDF ↗ |
| K953634 | SHIMASONIC SDU-350 ELECTRONIC LINEAR/CONVEX DIAGNOSTIC ULTRASOUND SYSTEM | Shimadzu Medical Systems | 1996-02-13 | Traditional | PDF ↗ |
| K943315 | ULTRASOUND SCANNER 2002 | B&K Medical | 1996-02-09 | Traditional | PDF ↗ |
| K951999 | HOLOPSY SYSTEM | Neovision Corp. | 1996-01-05 | Traditional | PDF ↗ |
| K952551 | JANUS I | 3D Ultrasound, Inc. | 1995-12-11 | Traditional | PDF ↗ |
| K955094 | EXAMINATION PAD | Inventive Products, Inc. | 1995-11-09 | Traditional | PDF ↗ |
| K942243 | IMEX 8000 PERSONAL CASCULAR LAB | Imex Medical Systems, Inc. | 1995-11-03 | Traditional | PDF ↗ |
| K945795 | EUB-555A+ | Hitachi Medical Corp. of America | 1995-10-27 | Traditional | PDF ↗ |
| K953468 | SONOGEL | Sonotech, Inc. | 1995-10-17 | Traditional | PDF ↗ |
| K946179 | SIEMENS SONOLINE 4XX | Siemens Medical Solutions USA, Inc. | 1995-10-03 | Traditional | PDF ↗ |
| K950276 | MICROSOUND 6.6F DIAGNOSTIC IMAGING CATHETER MODEL 50302, INTRAVASCULAR ULTRASOUND IMAGING SYSTEM | Endosonics Corp. | 1995-09-22 | Traditional | PDF ↗ |
| K936024 | ULTRASOUND SCANNER 2001 | B & K Medical A/S | 1995-08-22 | Traditional | PDF ↗ |
| K941322 | ECHO-SCAN | Tomographic Tech | 1995-07-27 | Traditional | PDF ↗ |
| K951925 | DICOMIT | Dicomit Imaging Systems Corp. | 1995-07-12 | Traditional | PDF ↗ |
| K944597 | GRAHAM-FIELD ULTRASOUND SCANNING GEL | Chester Labs, Inc. | 1995-06-21 | Traditional | PDF ↗ |
| K926363 | MULTI-DOP S | Dantec Medical, Inc. | 1995-06-19 | Traditional | PDF ↗ |
| K931801 | MULTI-DOP X | Dantec Medical, Inc. | 1995-06-14 | Traditional | PDF ↗ |
| K944485 | 4000 AU ULTRASOUND IMAGING SYSTEM | Biosound, Inc. | 1995-05-24 | Traditional | PDF ↗ |
| K944004 | VISIONS 2.9F ULTRASONIC IMAGING CATHETER (MODEL 84300) | Endosonics Corp. | 1995-05-04 | Traditional | PDF ↗ |
| K943303 | PVK-357AT | Toshiba America Medical Systems, In.C | 1995-02-03 | Traditional | PDF ↗ |
| K943113 | SSD-2000 DIAGNOSTIC ULTRASOUND SYSTEM | Aloka Co., Ltd. | 1995-02-01 | Traditional | PDF ↗ |
| K934139 | TOMTEC ECHO-VIEW | Tomtec Tomographic Technologies GmbH | 1995-01-25 | Traditional | PDF ↗ |
| K923273 | AI 5200 DIAGNOSTIC ULTRASOUND SYSTEM | Acoustic Imaging Technologies Corp. | 1994-12-27 | Traditional | PDF ↗ |
| K925582 | MEDISON 4800 | Medison America, Inc. | 1994-12-27 | Traditional | PDF ↗ |
| K944523 | HUMPHREY OCT (OPTICAL COHERENCE TOMOGRAPHY) SCANNER | Humphrey, Inc. | 1994-12-15 | Traditional | PDF ↗ |
| K931021 | SHIMASONIC SDU-400 ELECTRONIC LINEAR/CONVEX D.U.S. | Shimadzu Medical Systems | 1994-11-14 | Traditional | PDF ↗ |
| K940151 | ULTRASOUND PROBE DRAPE | Hydro-Med Products, Inc. | 1994-11-14 | Traditional | PDF ↗ |
| K930964 | ACUSON MODEL #29001 (DIAGNOSTIC ULTRASOUND DEVICE) | Acuson Corp. | 1994-10-26 | Traditional | PDF ↗ |
| K925999 | SWEMED NEEDLE GUIDE | Swemed Lab Intl. | 1994-10-03 | Traditional | PDF ↗ |
| K943634 | HP 77010CF | Hewlett-Packard Co. | 1994-09-30 | Traditional | PDF ↗ |
| K931909 | CLEAR IMAGE STERILE DIAGNOSTIC ULTRSOUND GEL | Sonomed Technology, Inc. | 1994-09-29 | Traditional | PDF ↗ |
Product code IYO · Class II · Radiology. Data: openFDA.