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 |
|---|---|---|---|
| Oct 1, 1996 | K963585 | BLADDER MANAGER PCI 5000, BLADDERSCAN BVI 5000 Diagnostic Ultrasound Corp. | IYO |
| Aug 28, 1996 | K960700 | LOGIQ A200 DIAGNOSTIC ULTRASOUND SYSTEM GE Medical Systems | IYO |
| Aug 8, 1996 | K961116 | FIRST BEAT/CARDIO BEAT/CALC Medasonics, Inc. | IYO |
| Aug 8, 1996 | K960765 | MENTOR ADVENT A/B SYSTEM Mentor Ophthalmics, Inc. | IYO |
| Jul 26, 1996 | K951976 | ECHO. AKHO Alliance Medical, Inc., CA | IYO |
| Jul 25, 1996 | K961029 | KILTEX PROBE COVER Kiltex Corp. | IYO |
| Jul 17, 1996 | K962308 | EUB-905 Hitachi Medical Corp. of America | IYO |
| May 28, 1996 | K954884 | PEDIATRIC MULTIPLANE TRANSESOPHAGEAL PROBE (PMPTE-PROBE), TN100065 Vingmed Sound, Inc. | IYO |
| May 24, 1996 | K955840 | BLADDERMANAGER PCI 5000 / BLADDERSCAN BVI 5000 Diagnostic Ultrasound Corp. | IYO |
| May 24, 1996 | K946349 | STENODOC Specs USA, Inc. | IYO |
| May 20, 1996 | K951449 | MODEL KM-25 Koven Technology, Inc. | IYO |
| May 17, 1996 | K941593 | DIAGNOSTIC ULTRASONIC TRANSDUCER Toshiba America Medical Systems, In.C | IYO |
| May 13, 1996 | K960622 | I-SCAN Ophthalmic Technologies, Inc., CA | IYO |
| May 7, 1996 | K950330 | DIGITAL IMAGE ACQUISITION SYSTEM International Imaging Electronics | IYO |
| Apr 15, 1996 | K951994 | OLYMPUS EU-M30 ENDOSCOPIC ULTRASOUND CENTER Olympus America, Inc. | IYO |
| Apr 8, 1996 | K953530 | DIAGNOSTIC ULTRASOUND TRANDUCERS P10A, P12A, PT10A, PA11-A Biosound, Inc. | IYO |
| Apr 5, 1996 | K950157 | SIEMENS Q64XXX Siemens Medical Solutions USA, Inc. | IYO |
| Mar 15, 1996 | K955942 | BLADDERSCAN BVI 5000 Diagnostic Ultrasound Corp. | IYO |
| Mar 15, 1996 | K953752 | RT55 DIAGNOSTIC ULTRASOUND SYSTEM General Electric Co. | IYO |
| Mar 14, 1996 | K953773 | 6.5 MHZ ENDORECTAL CONVEX ARRAY (10R) PROBE Medison America, Inc. | IYO |
| Mar 14, 1996 | K953673 | ECLIPSE PROBE COVER Parker Laboratories, Inc. | IYO |
| Mar 11, 1996 | K952540 | SONOS IMAGING SYSTEM (2000/2500 & 1000/1500) Hewlett-Packard Co. | IYO |
| Mar 7, 1996 | K950943 | ULTRA EASE Lectec Corp. | IYO |
| Feb 13, 1996 | K953634 | SHIMASONIC SDU-350 ELECTRONIC LINEAR/CONVEX DIAGNOSTIC ULTRASOUND SYSTEM Shimadzu Medical Systems | IYO |
| Feb 9, 1996 | K943315 | ULTRASOUND SCANNER 2002 B&K Medical, DK | IYO |
| Jan 5, 1996 | K951999 | HOLOPSY SYSTEM Neovision Corp. | IYO |
| Dec 11, 1995 | K952551 | JANUS I 3D Ultrasound, Inc. | IYO |
| Nov 9, 1995 | K955094 | EXAMINATION PAD Inventive Products, Inc. | IYO |
| Nov 3, 1995 | K942243 | IMEX 8000 PERSONAL CASCULAR LAB Imex Medical Systems, Inc. | IYO |
| Oct 27, 1995 | K945795 | EUB-555A+ Hitachi Medical Corp. of America | IYO |
| Oct 17, 1995 | K953468 | SONOGEL Sonotech, Inc. | IYO |
| Oct 3, 1995 | K946179 | SIEMENS SONOLINE 4XX Siemens Medical Solutions USA, Inc. | IYO |
| Sep 22, 1995 | K950276 | MICROSOUND 6.6F DIAGNOSTIC IMAGING CATHETER MODEL 50302, INTRAVASCULAR ULTRASOUND IMAGING SYSTEM Endosonics Corp. | IYO |
| Aug 22, 1995 | K936024 | ULTRASOUND SCANNER 2001 B & K Medical A/S, DK | IYO |
| Jul 27, 1995 | K941322 | ECHO-SCAN Tomographic Tech | IYO |
| Jul 12, 1995 | K951925 | DICOMIT Dicomit Imaging Systems Corp., CA | IYO |
| Jun 21, 1995 | K944597 | GRAHAM-FIELD ULTRASOUND SCANNING GEL Chester Labs, Inc. | IYO |
| Jun 19, 1995 | K926363 | MULTI-DOP S Dantec Medical, Inc. | IYO |
| Jun 14, 1995 | K931801 | MULTI-DOP X Dantec Medical, Inc. | IYO |
| May 24, 1995 | K944485 | 4000 AU ULTRASOUND IMAGING SYSTEM Biosound, Inc. | IYO |
| May 4, 1995 | K944004 | VISIONS 2.9F ULTRASONIC IMAGING CATHETER (MODEL 84300) Endosonics Corp. | IYO |
| Feb 3, 1995 | K943303 | PVK-357AT Toshiba America Medical Systems, In.C | IYO |
| Feb 1, 1995 | K943113 | SSD-2000 DIAGNOSTIC ULTRASOUND SYSTEM Aloka Co., Ltd. | IYO |
| Jan 25, 1995 | K934139 | TOMTEC ECHO-VIEW Tomtec Tomographic Technologies GmbH | IYO |
| Dec 27, 1994 | K925582 | MEDISON 4800 Medison America, Inc. | IYO |
| Dec 27, 1994 | K923273 | AI 5200 DIAGNOSTIC ULTRASOUND SYSTEM Acoustic Imaging Technologies Corp. | IYO |
| Dec 15, 1994 | K944523 | HUMPHREY OCT (OPTICAL COHERENCE TOMOGRAPHY) SCANNER Humphrey, Inc. | IYO |
| Nov 14, 1994 | K940151 | ULTRASOUND PROBE DRAPE Hydro-Med Products, Inc. | IYO |
| Nov 14, 1994 | K931021 | SHIMASONIC SDU-400 ELECTRONIC LINEAR/CONVEX D.U.S. Shimadzu Medical Systems | IYO |
| Oct 26, 1994 | K930964 | ACUSON MODEL #29001 (DIAGNOSTIC ULTRASOUND DEVICE) Acuson Corp. | IYO |
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