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 27, 2004 | K042833 | SONOLINE G20 DIAGNOSTIC ULTRASOUND SYSTEMS Siemens Medical Solutions USA, Inc. | IYO |
| Oct 4, 2004 | K042540 | PHILIPS IU22 ULTRASOUND SYSTEM Philips Ultrasound, Inc. | IYO |
| Sep 2, 2004 | K041639 | TARGETSCN TRANSRECTAL ULTRASOUND SYSTEM Envisioneering, LLC | IYO |
| Aug 16, 2004 | K041947 | I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND Innovative Imaging, Inc. | IYO |
| Jun 10, 2004 | K041455 | SSI-600/SSI-800 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM Sonoscape Company Limited | IYO |
| May 17, 2004 | K040652 | VUE 100 ULTRASOUND IMAGING SYSTEM Mobilsonic, Inc. | IYO |
| Apr 13, 2004 | K040668 | E-Z SCAN AB5500+ Sonomed, Inc. | IYO |
| Mar 26, 2004 | K040719 | ALOKA MODEL SSD-4000 DIAGNOSTIC ULTRASOUND SYSTEM W/OPTIONAL SONOREAL 3D SYSTEM ACCESSORY Aloka Co., Ltd. | IYO |
| Mar 9, 2004 | K040502 | SONOLINE EBISU DIAGNOSTIC ULTRASOUND SYSTEMS Siemens Medical Solutions USA, Inc. | IYO |
| Dec 24, 2003 | K033906 | PORTASCAN BLADDER SCANNER, MODEL PA00146 Mediwatch Plc, GB | IYO |
| Dec 15, 2003 | K033604 | TRINGA ULTRASOUND IMAGING SYSTEM, MODEL 50L Pie Medical | IYO |
| Nov 7, 2003 | K033385 | DGH 55 HANDHELD PACHYMETER (PACHMATE) Dgh Technology, Inc. | IYO |
| Oct 10, 2003 | K032956 | ACCUSONIC A-SCAN MODEL, 24-4000 Accutome, Inc. | IYO |
| Sep 30, 2003 | K032875 | ALOKA MODEL SSD-5500 V6.0 ULTRASOUND SYSTEM Aloka Co. Ltd USA | IYO |
| Sep 11, 2003 | K032640 | FULL FIELD BREAST IMAGING (FFBU) DIAGNOSTIC ULTRASOUND SYSTEM U-Systems, Inc. | IYO |
| Jul 21, 2003 | K032135 | SITE-RITE IV ULTRASOUND SYSTEM Dymax Corp | IYO |
| Jun 24, 2003 | K023430 | UF BRACHYTHERAPY STAND University of Florida | IYO |
| Jun 20, 2003 | K031391 | HF MODULE WITH TRANSDUCERS Ophthalmic Technologies, Inc. | IYO |
| Mar 27, 2003 | K030770 | OTI SCAN WITH TRANSDUCERS Ophthalmic Technologies, Inc. | IYO |
| Mar 26, 2003 | K030763 | DIAGNOSTIC ULTRASOUND BLADDERMASS BVM 6500 ULTRASOUND SYSTEM Diagnostic Ultrasound Corp. | IYO |
| Mar 21, 2003 | K030610 | POD PAC-20M Portable Ophthalmic Devices, Inc. | IYO |
| Jan 10, 2003 | K024114 | A-SCAN 100 Ophthalmic Technologies, Inc. | IYO |
| Dec 11, 2002 | K022928 | HUDSON 2020, 2040, 2060,ULTRASOUND SCANNERS Hudson Diagnostic Imaging, LLC | IYO |
| Nov 20, 2002 | K023473 | SONOREAL 3D Bio Medi Com | IYO |
| Nov 1, 2002 | K023457 | ULTRASOUND SCANNER, TYPE 1101 B-K Medical A/S, DK | IYO |
| Oct 8, 2002 | K021333 | ARTEMIS Ultralink, LLC | IYO |
| Aug 15, 2002 | K022153 | BLADDERSCAN BVI 6100 Diagnostic Ultrasound Corp. | IYO |
| Jul 10, 2002 | K020668 | ALOKA SSD-1000 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS ASU-1003, UST-9121, UST-9124 Aloka Co., Ltd. | IYO |
| Jun 21, 2002 | K021683 | CINESCAN S Quantel Medical | IYO |
| May 9, 2002 | K020561 | SONO-SCAN, SONO-SCAN PRO, CARDIO SCAN Tomtec Imaging Systems GmbH, DE | IYO |
| May 3, 2002 | K020876 | ECHOSCAN, MODEL US-1800 Nidek, Inc. | IYO |
| Apr 19, 2002 | K020112 | 50S TRINGA ULTRASOUND IMAGING SYSTEM Pie Medical | IYO |
| Apr 10, 2002 | K020151 | UD-1000 ULTRASONIC A/B SCANNER Tomey Corp. USA | IYO |
| Apr 8, 2002 | K012803 | AL-2000 COMBINED BIOMETER AND PACHYMETER Tomey Corp. | IYO |
| Apr 4, 2002 | K013088 | ECHOTECH EASY 3D FAMILY, ECHOTECH 3D FREESCAN, ECHOTECH EASYARCHIVE, ECHOTECH QUANTICON, ECHOTECH EASYSTRESS Echotech 3D Imaging Systems, Inc. | IYO |
| Mar 4, 2002 | K020068 | SONOREAL 3D SYSTEM Bio Medi Com | IYO |
| Jan 31, 2002 | K012727 | HUMPHREY OCT3 Carl Zeiss Ophthalmic Systems, Inc. | IYO |
| Jan 16, 2002 | K014206 | LOGIQBOOK General Electric Co. | IYO |
| Dec 14, 2001 | K013327 | CTS-415 Shantou Institute of Ultrasonic Instuments | IYO |
| Nov 13, 2001 | K013633 | SSA-770A, APLIO ULTRASOUND SYSTEM Toshiba America Medical Systems, In.C | IYO |
| Oct 5, 2001 | K013142 | DIASUS Dynamic Imaging , Ltd., GB | IYO |
| Oct 1, 2001 | K012772 | CTS-485 ULTRASOUND IMAGING SYSTEM Shantou Institute of Ultrasonic Instuments | IYO |
| Sep 26, 2001 | K012084 | SONOREAL 3D Bio Medi Com | IYO |
| Sep 12, 2001 | K012887 | SA6000II DIAGNOSTIC ULTRASOUND SYSTEM Medison America, Inc. | IYO |
| Aug 30, 2001 | K012253 | SSD-1000 DIAGNOSTIC ULTRASOUND SYSTEM Aloka Co., Ltd. | IYO |
| Aug 23, 2001 | K012560 | GE LOGIQ A100 MP, MODEL 2272413 General Electric Co. | IYO |
| Jun 27, 2001 | K010950 | CYPRESS SYSTEM Acuson Corp. | IYO |
| Jun 13, 2001 | K011095 | MODEL I0-3DUIMS 3D ULTRASOUND MANAGEMENT SYSTEM Iodp SA | IYO |
| Jun 8, 2001 | K011417 | ULTRASOUND SCANNER, TYPE 2102 B-K Medical A/S, DK | IYO |
| May 30, 2001 | K011252 | EUB-6000 DIAGNOSTIC ULTRASOUND SCANNER SP-711 SONOPROBE SYSTEM Hitachi Medical Corp. | IYO |
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