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 |
|---|---|---|---|
| Jul 3, 2007 | K071156 | SOUNMED SD-2000 PLUS PORTABLE ULTRASOUND SCANNER Sounmed, Inc. | IYO |
| May 22, 2007 | K071314 | SONOLINE G20 DIAGNOSTIC ULTRASOUND SYSTEMS Siemens Medical Solutions USA, Inc. | IYO |
| May 18, 2007 | K071204 | SITE-RITE 6 ULTRASOUND SYSTEM, MODEL SITE-RITE 6 C.R. Bard, Inc. | IYO |
| May 17, 2007 | K071217 | BLADDERSCAN BVI 9400 ULTRASOUND Verathon Incorporated | IYO |
| May 8, 2007 | K071134 | SONOSITE MAXX SERIES DIAGNOSTIC ULTRASOUND SYSTEM Sonosite,Inc. | IYO |
| May 2, 2007 | K070982 | CTS-7700 DIGITAL ULTRASOUND IMAGING SYSTEM Shantou Institute of Ultrasonic Instuments | IYO |
| Apr 19, 2007 | K070943 | B-SCAN PLUS Accutome Ultrasound, Inc. | IYO |
| Apr 17, 2007 | K070907 | INTERSON USB ULTRASOUND PROBE SYSTEM Regulatory Management Services | IYO |
| Apr 11, 2007 | K070884 | POD B-SCAN Starfish Product Engineering, Inc., CA | IYO |
| Mar 23, 2007 | K070526 | DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYO |
| Mar 9, 2007 | K070477 | ORISON EMBRACE SYSTEM Orison Corporation | IYO |
| Mar 5, 2007 | K070077 | ULTRASOUND SCANNER PROFOCUS, MODEL 2202 B-K Medical Aps, DK | IYO |
| Jan 31, 2007 | K063472 | ULTRASONIC BIOMETER/ PACHYMETER FOR OPHTHALMOLOGY, MODEL ODM 2100, 2200 Meda , Ltd. | IYO |
| Jan 29, 2007 | K063433 | ULTRASONIC BIOMETER/PACHYMETER FOR OPTHALMOLOGY ODM 2100 AND ODM 2200 Meda , Ltd. | IYO |
| Nov 21, 2006 | K062571 | LONGPORT EPISCAN, MODEL-I-200 Longport, Inc. | IYO |
| Nov 14, 2006 | K063085 | MODIFICATION TO ACUSON SEQUOIA ULTRASOUND SYSTEM Siemens Medical Solutions USA, Inc. | IYO |
| Aug 10, 2006 | K061215 | VOLCANO S51 FAMILY OF IMAGING SYSTEMS Volcano Corporation | IYO |
| Aug 7, 2006 | K061755 | MYLAB15/20 NEW INDICATIONS ULTRASOUND SYSTEM Esaote Europe B.V. | IYO |
| Jul 14, 2006 | K061641 | ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SARANO Shimadzu Medical Systems | IYO |
| Jul 12, 2006 | K061682 | GE VOLUSON E8 ULTRASOUND SYSTEM General Electric Co. | IYO |
| Jun 23, 2006 | K060483 | VOLCANO ANGIO-IVUS MAPPING (AIM) SYSTEM Volcano Corporation | IYO |
| Jun 6, 2006 | K061083 | CTS-7700 Shantou Institute of Ultrasonic Instuments | IYO |
| Jun 1, 2006 | K061189 | DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYO |
| May 4, 2006 | K060949 | DP-6600 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYO |
| Apr 19, 2006 | K053306 | IVIEW Ondemandsoft | IYO |
| Apr 11, 2006 | K060626 | VUMAX Sonomed, Inc. | IYO |
| Apr 7, 2006 | K060800 | SEEKER/SPARK ULTRASOUND SYSTEM Ardent Sound, Inc. | IYO |
| Dec 9, 2005 | K053346 | MODIFICATION TO: DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL DP-9900 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYO |
| Dec 7, 2005 | K053325 | MEDIWATCH MULTISCAN ULTRASOUND SYSTEM/SCANNER, MODEL M0002 (SCANNER ONLY); MULTISCAN ULTRASOUND SYSTEM, MODEL M0001 Mediwatch, Ltd., GB | IYO |
| Dec 2, 2005 | K052348 | IN VISION GOLD WITH SPIN VISION, MODEL 891 SV Volcano Corporation | IYO |
| Sep 14, 2005 | K052355 | AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS U-Systems, Inc. | IYO |
| Aug 19, 2005 | K051920 | VOLCANO S5 IMAGING SYSTEM, MODEL 804200-001 Volcano Corporation | IYO |
| Aug 9, 2005 | K052113 | DP-6600 ULTRASONIC DIAGNOSTIC IMAGING SYSTEM Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYO |
| Aug 3, 2005 | K051851 | AVISO OPHTHALMIC ULTRASOUND SYSTEM Quantel Medical | IYO |
| Jun 17, 2005 | K051500 | FAMIO DIAGNOSTIC ULTRASOUND SYSTEMS, MODEL SSA-530A Toshiba America Medical Systems, In.C | IYO |
| Jun 3, 2005 | K051304 | ISCIENCE SURGICAL OPHTHALMIC IMAGING SYSTEM Science Surgical Corporation | IYO |
| May 26, 2005 | K050980 | ULTRASONIC BIO-MICROSCOPE, MODEL P60 Paradigm Medical Industries, Inc. | IYO |
| Mar 28, 2005 | K050552 | PACHPEN PACHYMETER, MODEL 24-5100 Accutome, Inc. | IYO |
| Mar 22, 2005 | K050551 | VOYAGER PERSONAL IMAGING DEVICE Ardent Sound, Inc. | IYO |
| Feb 9, 2005 | K043189 | SONALIS, MODEL 2000 3g Ultrasound, Inc. | IYO |
| Feb 8, 2005 | K050167 | CHISON 600M WITH C60 CONVEX PROBE, L700 LINEAR PROBE Chison Medical Imaging Co., Ltd., CN | IYO |
| Jan 11, 2005 | K043563 | DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYO |
| Dec 23, 2004 | K042620 | SONATA 3-D IMAGING ACCESSORY, MODEL 3DS Tetrad Corp. | IYO |
| Dec 10, 2004 | K043287 | PALMSCAN AP2000; PALMSCAN A2000; PALMSCAN P2000 Micromedical Devices, Inc. | IYO |
| Dec 9, 2004 | K043275 | OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CENTER Olympus Medical Systems Corporation | IYO |
| Nov 17, 2004 | K043078 | NEMIO DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-550A Toshiba America Medical Systems, In.C | IYO |
| Nov 12, 2004 | K042250 | SENSATOUCH Aluna Management Co., Ltd. | IYO |
| Nov 10, 2004 | K042752 | ACCUPACH V Accutome Ultrasound, Inc. | IYO |
| Nov 10, 2004 | K042188 | VOLCANO THERAPEUTICS, INC. VOLCANO IVUS SYSTEM Volcano Therapeutics, Inc. | IYO |
| Oct 28, 2004 | K042831 | ATP (AUTO NON-CONTACT TONOMETER/PACHYMETER) Reichert, Inc. | IYO |
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