Transducer, Ultrasonic, Diagnostic
Regulation 892.1570
6510(k)s in 12 months (415 all time)
13recalls in 12 months (147 all time)
118recalls that name a 510(k)
Top companies in ITX
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 21, 2008 | K080119 | CLEARSCAN Esi, Inc. | ITX |
| Jan 9, 2008 | K071291 | ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100 Shimadzu Medical Systems | ITX |
| Jan 9, 2008 | K071289 | ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO Shimadzu Medical Systems | ITX |
| Jan 9, 2008 | K071287 | ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND DEVICE, MODEL SDU-2200PRO Shimadzu Medical Systems | ITX |
| Nov 13, 2007 | K072786 | ACUSON S2000 ULTRASOUND SYSTEM Siemens Medical Solutions USA, Inc. | ITX |
| Oct 29, 2007 | K072918 | MODEL SSA-680A XARIO XG DIAGNOSTIC ULTRASOUND SYSTEM, VERSION 1.00 Toshibamedical Systems Corporation | ITX |
| Oct 24, 2007 | K072826 | APLIO ARTIDA DIAGNOSTIC ULTRASOUND SYSTEM Toshiba America Medical Systems, In.C | ITX |
| Oct 15, 2007 | K070195 | BROADSOUND, AL3C34A,AL7L50A, AL3C79B,AL7L24B, AT3P42A, AT3C52B, ATL5L40B, AT3P32A, AT3C42B Broadsound Corporation, TW | ITX |
| Sep 25, 2007 | K072541 | SENOSONIX ULTRASOUND BREAST BIOPSY SYSTEM Senorx, Inc. | ITX |
| Sep 5, 2007 | K072164 | DC-6 DIAGNOSTIC ULTRASOUND SYSTEM Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN | ITX |
| Aug 30, 2007 | K072285 | ALOKA SSD-ALPHA 7 ULTRASOUND SYSTEM Aloka Co., Ltd. | ITX |
| Aug 29, 2007 | K072266 | ACUSON P50 DIAGNOSTIC ULTRASOUND SYSTEM Siemens Medical Solutions USA, Inc. | ITX |
| Jul 30, 2007 | K070515 | A-VIEW BASIC AND PLUS Cordatec N.V. | ITX |
| Jul 2, 2007 | K070903 | MYLAB40 Esaote Europe B.V. | ITX |
| Oct 27, 2006 | K061153 | GYNESONICS EC6 TRANSDUCER Gynesonics, Inc. | ITX |
| Aug 18, 2006 | K061560 | SONOMARK Medical Products Manufacturing, Inc. | ITX |
| Apr 19, 2006 | K060947 | SONICATH ULTRA IMAGING CATHETER, 3.2F,20MHZ MODELS 37410/456221/C1020 Boston Scientific Corp | ITX |
| Apr 19, 2006 | K060879 | MODEL EC9-4 TRANSDUCER Siemens Medical Solutions USA, Inc. | ITX |
| Mar 7, 2006 | K053463 | AIM ACCURACY IN MARKING SYSTEM Georgene Austria | ITX |
| Sep 29, 2005 | K052517 | SITE-RITE 5 ULTRASOUND SYSTEM C.R. Bard, Inc. | ITX |
| Aug 17, 2005 | K052021 | V5MS TRANSDUCER AND MPT7-4 MULTIPLANE TRANSESOPHAGEAL TRANSDUCER Siemens Medical Solutions USA, Inc. | ITX |
| Aug 15, 2005 | K050320 | FREESCAN LATEX-FREE ULTRASOUND TRANSDUCER COVER KIT Ascendia Medtech AB | ITX |
| Apr 18, 2005 | K050724 | SURE-POINT MIDLINE STEPPING AND STABILIZATION SYSTEM C.R. Bard, Inc. | ITX |
| Feb 28, 2005 | K043425 | SHEATHES NEEDLE GUIDE, MODEL NG-SR-A-484-KIT (THERE WILL BE VARIOUS MODEL NUMBERS BASED ON TRANSDUCER AND COVER) Sheathing Technologies, Inc. | ITX |
| Dec 13, 2004 | K043278 | TERATECH MODEL 8IOC4, 8IOL4 & 10LAP4 PROBES Teratech Corp. | ITX |
| Nov 18, 2004 | K032315 | IOP8 INTRA OPERATIVE PROBE Huntleigh Healthcare, Inc., GB | ITX |
| Nov 10, 2004 | K041818 | SONICATH ULTRA IMAGING CATHETER 3.2F 20MHZ, MODELS 37410/456221/C1020 Boston Scientific Corp | ITX |
| Oct 19, 2004 | K042445 | SITE-RITE NEEDLE GUIDE KITS AND PROBE COVER KIT Bard Access Systems, Inc. | ITX |
| Sep 22, 2004 | K040213 | MHLX7EC TRANSDUCER Microhelix, Inc. | ITX |
| Sep 2, 2004 | K041638 | TARGETSCAN BIOPSY KIT Envisioneering, LLC | ITX |
| Sep 1, 2004 | K041637 | TARGETSCAN TRANSRECTAL ULTRASOUND SYSTEM Envisioneering, LLC | ITX |
| Jun 9, 2004 | K041397 | EG-3830UT Pentax Precision Instrument Corp. | ITX |
| Jun 9, 2004 | K041396 | FG-36UX FIBER ULTRASOUND GASTROSCOPE Pentax Precision Instrument Corp. | ITX |
| Jun 9, 2004 | K041395 | EG-3630UR Pentax Precision Instrument Corp. | ITX |
| Apr 14, 2004 | K040840 | TERATECH MODEL 10V5 SMART PROBE Teratech Corp. | ITX |
| Sep 11, 2003 | K022156 | LATEX ULTRASONIC PROBE COVER Pleasure Latex Products Sdn. Bhd., MY | ITX |
| Jul 23, 2003 | K031920 | CROSSPOINT TRANSACCESS CATHETER, MODEL TA-XP-001 Trans Vascular Incorporated | ITX |
| May 20, 2003 | K030518 | AMERITEK SURE-POINT TRACKER SYSTEM Amertek Medical, Inc. | ITX |
| May 9, 2003 | K031358 | TRANSVAGINAL DOPPLER PROBE Vascular Control Systems, Inc. | ITX |
| Jan 22, 2003 | K030064 | ILOOK 25 NEEDLE GUIDE ATTACHMENT AND BRACKET ASSEMBLY Sonosite,Inc. | ITX |
| Nov 21, 2002 | K022860 | ATLANTIS PV IMAGING CATHETER, MODEL 36456 Boston Scientific, Target | ITX |
| Sep 26, 2002 | K023024 | TRANSVAGINAL DOPPLER PROBE, MODEL 09-0006-02 Vascular Control Systems, Inc. | ITX |
| Sep 6, 2002 | K022649 | COOK-SWARTZ DOPPLER FLOW PROBE Cook Vascular, Inc. | ITX |
| Apr 2, 2002 | K013363 | CROSSPOINT TRANSACCESS CATHETER Trans Vascular Incorporated | ITX |
| Feb 6, 2002 | K013723 | MODIFICATION TO: EUB-6500 DIAGNOSTIC ULTRASOUND SCANNER Hitachi Medical Corp. | ITX |
| Jan 3, 2002 | K014182 | TETRAD MODEL TC-C52-, -C84V-, -C95-, -CLA76-, -L74-ATP TRANSDUCERS Tetrad Corp. | ITX |
| Dec 28, 2001 | K013721 | SYNTHETIC POLYSIOPRENE ULTRASOUND TRANSDUCER COVER CIVCO Medical Instruments Co., Inc. | ITX |
| Dec 18, 2001 | K002958 | SHAPEABLE DOPPLER FLOW PROBE Cook Vascular, Inc. | ITX |
| Dec 3, 2001 | K013849 | TETRAD MODEL TC-EC7-ACP, -L5-, -L7-, -V4-ACP TRANSDUCERS Tetrad Corp. | ITX |
| Nov 13, 2001 | K013170 | SCANTAC MEMBRANE OR SCANTAC STRIP Sonotech, Inc. | ITX |
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