System, Imaging, Pulsed Echo, Ultrasonic
Regulation 892.1560
11510(k)s in 12 months (898 all time)
9recalls in 12 months (83 all time)
80recalls that name a 510(k)
Top companies in IYO
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 17, 1999 | K983945 | CORTEX DERMASCAN C ULTRASONIC SYSTEM Cortex Technology Aps, DK | IYO |
| Mar 5, 1999 | K984382 | ACCU GUIDE Tayman Medical, Inc. | IYO |
| Mar 2, 1999 | K990490 | SSA-320A JUST VISION 200/ SSA-325A JUST VISION Toshiba America Medical Systems, In.C | IYO |
| Feb 9, 1999 | K990226 | GE LOGIQ700 DIAGNOSTIC ULTRASOUND SYSTEM WITH B-FLOW Ge Medical Systems, Inc. | IYO |
| Nov 9, 1998 | K982840 | BSC SONICATH ULTRA INTRAVASCULAR ULTRASOUND IMAGING WIRE WITH DETACHABLE ADAPTER & BSC SONICATH ULTRA ULTRASOUND IMAGING Boston Scientific Corp | IYO |
| Oct 28, 1998 | K981528 | SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM Siemens Medical Solutions USA, Inc. | IYO |
| Oct 6, 1998 | K982444 | 7250 ULTRASOUND IMAGING SYSTEM Biosound Esaote, Inc. | IYO |
| Sep 22, 1998 | K982800 | ECTON LYNX ULTRASOUND SYSTEM Ecton, Inc. | IYO |
| Aug 7, 1998 | K980423 | SONOPSY LA SYSTEM Neovision Corp. | IYO |
| Jul 14, 1998 | 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. | IYO |
| Jun 30, 1998 | K981293 | 7200 ULTRASOUND IMAGING SYSTEM Biosound Esaote, Inc. | IYO |
| Jun 29, 1998 | K965223 | RESOLVE OPTION FOR THE ORACLE IN VISION INTRAVASCULAR ULTRASONIC IMAGING SYSTEM Endosonics Corp. | IYO |
| Jun 8, 1998 | K974880 | PERCEPTION GPS-RST DIAGNOSTIC ULTRASOUND SYSTEM Perception, Inc. | IYO |
| May 27, 1998 | K981626 | SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM Siemens Medical Solutions USA, Inc. | IYO |
| May 22, 1998 | K980687 | SONOS 5500 ULTRASOUND IMAGING SYSTEM Hewlett-Packard Co. | IYO |
| May 20, 1998 | K981404 | FUKUDA DENSHI ULTRASOUND SCANNERS MODELS UF-3500 AND UF-4500 Fukuda Denshi USA, Inc. | IYO |
| May 8, 1998 | K981510 | SONOACE 6000/ ULTRAMARK 400 Medison America, Inc. | IYO |
| May 8, 1998 | K981505 | COZUMEL DIAGNOSTIC ULTRASOUND SYSTEM Sonosite,Inc. | IYO |
| May 6, 1998 | K980308 | ECHOTECH 3D FREESCAN Echotech 3D Imaging Systems GmbH | IYO |
| Apr 22, 1998 | K980851 | GALAXY INTRAVASCULAR ULTRASOUND SYSTEM, MODEL I5028 Boston Scientific Corp | IYO |
| Apr 2, 1998 | K980860 | HDI 1000 DIAGNOSTIC ULTRASOUND SYSTEM Atlantis Diagnostics Intl., Inc. | IYO |
| Mar 4, 1998 | K973802 | SHIMASONIC LINEAR/CONVEX DIAGNOSTIC ULTRASOUND SYSTEM Shimadzu Medical Systems | IYO |
| Feb 25, 1998 | K974522 | 3D I-SCAN Ophthalmic Technologies, Inc. | IYO |
| Feb 9, 1998 | K974432 | ULTRAGUIDE 1000 Ultraguide , Ltd. | IYO |
| Dec 23, 1997 | K973767 | HARMONIC IMAGING WITH CONTRAST Acuson Corp. | IYO |
| Dec 22, 1997 | K970901 | GE LOGIQ 500 DIAGNOSTIC ULTRASOUND SYSTEM GE Medical Systems | IYO |
| Dec 17, 1997 | K972192 | PERCEPTION INC. GPS-XYZ DIAGNOSTIC ULTRASOUND SYSTEM Perception, Inc. | IYO |
| Dec 12, 1997 | K971528 | ENDOSCOPICALLY DELIVERALBE ULTRASOUND POINT PORBE SYSTEM (ENDOSCOPY) Fujinon, Inc. | IYO |
| Nov 14, 1997 | K973450 | SENSOR PAD Inventive Products, Inc. | IYO |
| Oct 15, 1997 | K972973 | PERCEPTION INC. GPS-TUV DIAGNOSTIC ULTRASOUND SYSTEM Perception, Inc. | IYO |
| Oct 3, 1997 | K964617 | GE LOGIQ 700 DIAGNOSTIC ULTRASOUND SYSTEM GE Medical Systems | IYO |
| Aug 6, 1997 | K963290 | COLORFLO OPTION FOR THE ORACLE INVISION INTRAVASCULAR ULTRASONIC IMAGING SYSTEM Endosonics Corp. | IYO |
| Aug 4, 1997 | K970508 | ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM Shimadzu Medical Systems | IYO |
| May 29, 1997 | K963068 | CTS-200 WITH EZU-PL21 TRANSDUCER Shantou Institute of Ultrasonic Instuments | IYO |
| May 29, 1997 | K963065 | CTS-285 WITH EZU-PL21 AND EZU-PC3B TRANSDUCERS Shantou Institute of Ultrasonic Instuments | IYO |
| May 29, 1997 | K962142 | SONOLINE VERSA 555 DIAGNOSTIC ULTRASOUND SYSTEM Siemens Medical Solutions USA, Inc. | IYO |
| May 29, 1997 | K961229 | HR12000 ULTRASOUND SYSTEM International Ultrasound Corp. | IYO |
| Apr 24, 1997 | K962882 | SONOLINE VERSA PRO DIAGNOSTIC ULTRASOUND SYSTEM Siemens Medical Solutions USA, Inc. | IYO |
| Apr 21, 1997 | K963863 | JANUS I 3D Ultrasound, Inc. | IYO |
| Apr 4, 1997 | K970156 | IMEX FUTURALDOP PRO Imex Medical Systems, Inc. | IYO |
| Mar 26, 1997 | K961459 | LEVEL 10 HDI Advanced Technology Laboratories, Inc. | IYO |
| Mar 19, 1997 | K963706 | PHILIPS SONO DIAGNOST 800 Hewlett-Packard Co. | IYO |
| Mar 17, 1997 | K963315 | VINGMED SOUND COLOR FLOW MAPPING SYSTEM. SYSTEM FIVE Vingmed Sound, Inc. | IYO |
| Feb 19, 1997 | K961073 | ATLAS 2.0 & HITACHI 2.0 (A TRADE NAME SUBJECT TO CHANGE) Atlantis Diagnostics Intl., Inc. | IYO |
| Feb 19, 1997 | K940942 | COMBISON 530 DIAGNOSTIC ULTRASOUND SCANNER Medison America, Inc. | IYO |
| Feb 11, 1997 | K955543 | ULTRASOUND SYSTEM MODEL UF-3500 Fukuda Denshi USA, Inc. | IYO |
| Jan 2, 1997 | K962662 | VINGMED SOUND COLOR FLOW MAPPING SYSTEM Diasonics, Inc. | IYO |
| Dec 18, 1996 | K963807 | TOMTEC ECHO-SCAN Tomtec Imaging Systems, Inc. | IYO |
| Oct 31, 1996 | K963274 | V-LINK 3.2 FOR WINDOWS Koven Technology, Inc. | IYO |
| Oct 29, 1996 | K961833 | SONOLINE ELEGRA WITH SIESCAPE FEATURE Siemens Medical Solutions USA, Inc. | IYO |
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