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
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 2, 2018 | CIVCO Medical Instruments Co., Inc. CIVCO Needle Guide Starter Kit, REF numbers P12920-01 and P12920-02, Reusable non-sterile bracket with sterile (1.5cm, 2.5cm, 3.5cm, 4.5cm depths) needle guides (5), (10.2 x 147cm) CIV-Flex covers (( Terminated |
ITX | K030064 |
| Nov 2, 2018 | CIVCO Medical Instruments Co., Inc. SonoSite FUJIFILM Needle Guide Bracket, REF number P06013-08, Reusable non-sterile bracket for use with SonoSite L25 series transducers. Mfg for: Terminated |
ITX | K030064 |
| Nov 2, 2018 | CIVCO Medical Instruments Co., Inc. SonoSite Needle Guide Bracket, REF numbers P06013-06 and P06013-07, Reusable non-sterile bracket for use with SonoSite L25 series transducers. Terminated |
ITX | K030064 |
| Nov 2, 2018 | CIVCO Medical Instruments Co., Inc. CIVCO Biopsy Bracket, REF P03122-07, Reusable non-sterile single-angle bracket for use with SonoSite L25 series transducers. Terminated |
ITX | K030064 |
| Nov 2, 2018 | CIVCO Medical Instruments Co., Inc. CIVCO Needle Guide Bracket, REF P03122-06, Reusable non-sterile bracket for use with SonoSite L25/L25e transducers, Mfg by: CIVCO, Kalona, IA. Terminated |
ITX | K030064 |
| Nov 2, 2018 | CIVCO Medical Instruments Co., Inc. SonoSite L25 Bracket Kit containing 1 Reusable non-sterile bracket, REF numbers P03122-01, P03122-02, P03122-03, P03122-04, and P03122-05, Mfg for: SonoSite, Inc., Bothell, WA. Terminated |
ITX | K030064 |
| Nov 2, 2018 | CIVCO Medical Instruments Co., Inc. CIVCO Needle Guide Bracket, REF numbers M001457100, P06013-10, and P03122-08, reusable non-sterile single-angle bracket for use with SonoSite L25 series tranducers, RX. The firm name on the label is Terminated |
ITX | K030064 |
| Jul 30, 2018 | Civco Medical Instruments Co. Inc. CIVCO Needle Guide, REF 676-150, QTY 24, STERILE EO Terminated |
ITX | K970514 |
| Jul 30, 2018 | Civco Medical Instruments Co. Inc. CIVCO Needle Guide, REF 676-144, QTY 24, STERILE EO Terminated |
ITX | K970514 |
| Feb 23, 2018 | Civco Medical Instruments Co. Inc. CIVCO lnfiniti Needle Guide Bracket. used for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers.
Product Usage:
The bracket and disposable guide pro Terminated |
ITX | K093713 |
| Oct 20, 2017 | Hitachi Medical Systems America Inc Ultrasound Transducer, Model Number: UST-5550-R, is used in conjunction with a diagnostic ultrasound system evaluation during robotic and non-robotic intra-operative and laparoscopic procedures. Terminated |
ITX | K152126 |
| Jun 28, 2016 | Pentax Medical Company Ultrasound Gastroscope
Intended to provide optical visualization of, ultrasonic visualization of and therapeutic access to, the Upper Gastrointestinal Track including but not restricted to organs, tis Terminated |
ITX | K961974 |
| Nov 17, 2015 | Civco Medical Instruments Co. Inc. CIVCO Sales Demo Kit. REF DEMOGPGUIDE Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers. Terminated |
ITX | K093713 |
| Nov 17, 2015 | Civco Medical Instruments Co. Inc. CIVCO Tracking Bracket Starter Kit, Reusable non-sterile PercuNav tracking bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REF 667-132. Large Gauge Infiniti Plus Needle Gui Terminated |
ITX | K093713 |
| Nov 17, 2015 | Civco Medical Instruments Co. Inc. CIVCO Biopsy Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REFs 10787043, 11001906, 11001906(CMI), 613-247, 613-247(CMI), 620-116, 639-014, 6 Terminated |
ITX | K093713 |
| Nov 17, 2015 | Civco Medical Instruments Co. Inc. CIVCO Needle Guide Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REFs 674-030, 674-030-T, 674-031, 674-031-T, 674-035, 674-036, 674-044, Terminated |
ITX | K093713 |
| Nov 17, 2015 | Civco Medical Instruments Co. Inc. CIVCO Infiniti Plus Needle Guide, Sterile Needle Guide, 12-18GA, Rx ONLY, STERILE EO. REFs 610-1215, 610-1234, 610-1235, 610-1236. Large Gauge Infiniti Plus Needle Guides, used in needle-guided Terminated |
ITX | K093713 |
| Apr 8, 2015 | Civco Medical Instruments Inc CIVCO Surgi-Tip Transducer Cover Sterile (15.2 x 244 cm) polyethylene telescopically-folded cover with attached (3 cm) NeoGuard tip, REF 610-833. Each cover is packaged in a Tyvek pouch with accessor Terminated |
ITX | K013721 |
| Sep 3, 2014 | Siemens Medical Solutions USA, Inc. V5Ms Transesophageal transducers;
V5Ms trans-esophageal echocardiograph (TEE) ultrasound transducer is intended primarily for cardiology applications Terminated |
ITX | K121807 |
| Jan 30, 2014 | Boston Scientific Corporation Atlantis PV, 8.5F, 15 MHz Peripheral Imaging Catheter:
Sterile, R; Sterilized using irradiation.
Product Usage:
This catheter is a 15 MHz ultrasound imaging catheter intended to operate with an I Terminated |
ITX | K080272 |
| Apr 12, 2013 | Toshiba American Medical Systems Inc Aplio 500/400/300 Diagnostic Ultrasound System (TUS-500/400/300).
Device Listing Number: Dl53118.
Diagnostic Ultrasound system. Terminated |
ITX | None listed |
| May 3, 2012 | Pentax Medical Company EG-3870UTK, Pentax Ultrasound Video Gastroscope.
The EG-3870UTK, Ultrasound Video Gastroscope, is intended to provide optical visualization via a video monitor of, ultrasonic visualization of, and th Terminated |
ITX | K090197 |
| Apr 12, 2011 | Siemens Medical Solutions USA, Inc. Auxiliary 2 MHz Continuous Wave (CW) transducer, model number 8251046, when used with ACUSON Sequoia ultrasound systems at SW revision 12.X. Manufactured by Siemens Medical Solutions USA, Inc., Ultra Terminated |
ITX | K063085 |
| Mar 28, 2011 | Siemens Medical Solutions USA, Inc., Mountain View, CA ACUSON X300, X300 PE and SONOVISTA X300 (all versions) with cardiovascular options installed;
ACUSON X300: 10037409, 10132987, 10038837;
SONOVISTA X300: 10133170;
ACUSON X300 PE: 10348531, 10348532, 1 Terminated |
ITX | K072676 |
| Mar 8, 2011 | Civco Medical Instruments Inc CIVCO Latex Free NeoGuard Transducer Cover, Ref 676-117, Sterile (2.6 x 30cm) cover, packaged 24/box. The firm name on the label is CIVCO, Kalona, IA. Terminated |
ITX | K013721 |
| Feb 22, 2011 | Siemens Medical Solutions USA, Inc. V5M TEE Transducer, when used with an ACUSON S2000 ultrasound system that has cardiac options installed and is at software version VA10, VA10A, VA10B, VA10C, VA15, VA15A, VA15B, VA16 or VA16A, manufac Terminated |
ITX | K082142 |
| Feb 1, 2011 | Siemens Medical Solutions USA, Inc. 10430054 Acuson with Physio Module, manufactured by Siemens Medical Solutions, Mountain View, CA. Terminated |
ITX | K063803 K082142 |
| Jan 12, 2011 | Siemens Medical Solutions USA, Inc. Acuson Antares Ultrasound System
Diagnostic Ultrasound system Terminated |
ITX | K052021 |
| Oct 26, 2010 | Verathon, Inc. The label (which is affixed to ScanPoint Communications Cradle) states: "...VERATHON ScanPoint Docking Station...Part No. 0570-0168...Bothell, WA USA..." Terminated |
ITX | K022153 K030763 |
| Aug 20, 2010 | Civco Medical Instruments Inc CIVCO Surgi-Tip Transducer Cover, Ref. 610-834, Sterile (20.3 x 244cm) polyethylene telescopically-folded cover with attached (6cm) NeoGuard tip. The latex-free surgi tipped covers are utilized to cov Terminated |
ITX | K013721 |
| Jul 13, 2010 | Toshiba American Medical Systems Inc PVT-681MV Endocavitary Transducer used with the Aplio XG and Xario XG Ultrasound Systems. Terminated |
ITX | K072918 K092179 |
| Sep 9, 2009 | Hitachi Medical Systems America Inc EUB-9500/HI VISION 8500 Diagnostic Ultrasound Scanners,
DICOM Option EZU-FC6, Software Versions: V11-01, V11-03, V12-03 and V12-04A. Terminated |
ITX | K013722 |
| Sep 9, 2009 | Hitachi Medical Systems America Inc EUB-6500/HI VISION 6500 Diagnostic Ultrasound Scanners, DICOM Option EZU-FC5, Software Versions: V01-03, V01-05, V02-04, V03-02, V04-02, V04-03, V04-04, V05-03, V05-05A, V05-07A and V05-30A. Terminated |
ITX | K013723 |
| Jan 28, 2009 | Boston Scientific Corporation Atlantis PV Peripheral Imaging Catheter, model number H749364560, catalog number 36456, manufactured by Boston Scientific Corporation, Fremont, CA.
Medical device, intended for ultrasound examination Terminated |
ITX | K080272 |
| Mar 19, 2008 | Civco Medical Instruments Inc CIVCO Latex-Free Needle Guide, Sterile transrectal needle guide for use with Shimadzu UB1OR-065U transducer, Part #677-057, packaged 1 needle guide per tyvek pouch, 20 pouches per box. The label sho Terminated |
ITX | K970514 |
| May 5, 2007 | Toshiba American Med Sys Inc Nemio XG, ultrasound system, SSA-590A with version 1.5 software, Toshiba American Medical Systems, Inc., Tusin, CA. Terminated |
ITX | K061605 |
| Nov 29, 2006 | Computerized Medical Systems Inc AccuSeed DS Digital Stepper, an accessory to a prostate radiation treatment planning system. Model #DS300 Terminated |
ITX | K963302 |
| Nov 22, 2006 | Medtronic Vascular Pioneer Catheter (Crosspoint TransAccess Catheter);
Model TA-XP-001; Product is manufactured and distributed by Medtronic Vascular, Santa Rosa, CA 95403 Terminated |
ITX | K031920 |
| Jan 19, 2006 | Sonosite, Inc. SonoSite L25 Needle Guide Kit, 21 GAUGE, Part Number P04053-01. Manufactured for: SonoSite, Inc., Bothell, WA 98021 Each kit is packaged in a hermetically sealed clear plastic pouch with white back Terminated |
ITX | K030064 |
| Apr 22, 2005 | Bard Access Systems, Inc Site Rite II, Site Rite 3, and Site Rite IV Systems with 2 Sterile Kits each. Terminated |
ITX | None listed |
| Apr 22, 2005 | Bard Access Systems, Inc Ultra/Phonic Conductivity Gel, 20 ml. Each unit is a foil to foil pouch. Product is packaged 25 pouches per box. Terminated |
ITX | None listed |
| Apr 22, 2005 | Bard Access Systems, Inc Intraoperative Ultrasound Cover Kit Terminated |
ITX | None listed |
| Apr 22, 2005 | Bard Access Systems, Inc Site-Rite Sterile Ultrasound Probe Cover with Gel Terminated |
ITX | None listed |
| Apr 22, 2005 | Bard Access Systems, Inc Site-Rite Sterile Needle Guide Kit - 21 Gauge Terminated |
ITX | None listed |
| Apr 22, 2005 | Bard Access Systems, Inc Site-Rite Sterile Needle Guide Kit - 20 gauge Terminated |
ITX | None listed |
| Apr 22, 2005 | Bard Access Systems, Inc Site-Rite Sterile Needle Guide Kit - 18 gauge Terminated |
ITX | None listed |
| Jul 20, 2004 | Hitachi Medical Systems America Inc Hitachi HI VISION 6500, Model #EUB-6500, Ultrasound Diagnostic Scanner Device, Software Version V04-04 DICOM ServicePack 1 and EZU-FC5W. Terminated |
ITX | K013723 |
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