ClearanceBrief
Panels › Radiology › Product code ITX · Class 2

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)
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Top companies in ITX

DateFirm and productCodeLinked 510(k)
Nov 2, 2018CIVCO 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
ITXK030064
Nov 2, 2018CIVCO 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
ITXK030064
Nov 2, 2018CIVCO 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
ITXK030064
Nov 2, 2018CIVCO Medical Instruments Co., Inc.
CIVCO Biopsy Bracket, REF P03122-07, Reusable non-sterile single-angle bracket for use with SonoSite L25 series transducers.
Terminated
ITXK030064
Nov 2, 2018CIVCO 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
ITXK030064
Nov 2, 2018CIVCO 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
ITXK030064
Nov 2, 2018CIVCO 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
ITXK030064
Jul 30, 2018Civco Medical Instruments Co. Inc.
CIVCO Needle Guide, REF 676-150, QTY 24, STERILE EO
Terminated
ITXK970514
Jul 30, 2018Civco Medical Instruments Co. Inc.
CIVCO Needle Guide, REF 676-144, QTY 24, STERILE EO
Terminated
ITXK970514
Feb 23, 2018Civco 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
ITXK093713
Oct 20, 2017Hitachi 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
ITXK152126
Jun 28, 2016Pentax 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
ITXK961974
Nov 17, 2015Civco 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
ITXK093713
Nov 17, 2015Civco 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
ITXK093713
Nov 17, 2015Civco 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
ITXK093713
Nov 17, 2015Civco 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
ITXK093713
Nov 17, 2015Civco 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
ITXK093713
Apr 8, 2015Civco 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
ITXK013721
Sep 3, 2014Siemens Medical Solutions USA, Inc.
V5Ms Transesophageal transducers; V5Ms trans-esophageal echocardiograph (TEE) ultrasound transducer is intended primarily for cardiology applications
Terminated
ITXK121807
Jan 30, 2014Boston 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
ITXK080272
Apr 12, 2013Toshiba American Medical Systems Inc
Aplio 500/400/300 Diagnostic Ultrasound System (TUS-500/400/300). Device Listing Number: Dl53118. Diagnostic Ultrasound system.
Terminated
ITXNone listed
May 3, 2012Pentax 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
ITXK090197
Apr 12, 2011Siemens 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
ITXK063085
Mar 28, 2011Siemens 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
ITXK072676
Mar 8, 2011Civco 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
ITXK013721
Feb 22, 2011Siemens 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
ITXK082142
Feb 1, 2011Siemens Medical Solutions USA, Inc.
10430054 Acuson with Physio Module, manufactured by Siemens Medical Solutions, Mountain View, CA.
Terminated
ITXK063803
K082142
Jan 12, 2011Siemens Medical Solutions USA, Inc.
Acuson Antares Ultrasound System Diagnostic Ultrasound system
Terminated
ITXK052021
Oct 26, 2010Verathon, Inc.
The label (which is affixed to ScanPoint Communications Cradle) states: "...VERATHON ScanPoint Docking Station...Part No. 0570-0168...Bothell, WA USA..."
Terminated
ITXK022153
K030763
Aug 20, 2010Civco 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
ITXK013721
Jul 13, 2010Toshiba American Medical Systems Inc
PVT-681MV Endocavitary Transducer used with the Aplio XG and Xario XG Ultrasound Systems.
Terminated
ITXK072918
K092179
Sep 9, 2009Hitachi 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
ITXK013722
Sep 9, 2009Hitachi 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
ITXK013723
Jan 28, 2009Boston 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
ITXK080272
Mar 19, 2008Civco 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
ITXK970514
May 5, 2007Toshiba American Med Sys Inc
Nemio XG, ultrasound system, SSA-590A with version 1.5 software, Toshiba American Medical Systems, Inc., Tusin, CA.
Terminated
ITXK061605
Nov 29, 2006Computerized Medical Systems Inc
AccuSeed DS Digital Stepper, an accessory to a prostate radiation treatment planning system. Model #DS300
Terminated
ITXK963302
Nov 22, 2006Medtronic Vascular
Pioneer Catheter (Crosspoint TransAccess Catheter); Model TA-XP-001; Product is manufactured and distributed by Medtronic Vascular, Santa Rosa, CA 95403
Terminated
ITXK031920
Jan 19, 2006Sonosite, 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
ITXK030064
Apr 22, 2005Bard Access Systems, Inc
Site Rite II, Site Rite 3, and Site Rite IV Systems with 2 Sterile Kits each.
Terminated
ITXNone listed
Apr 22, 2005Bard 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
ITXNone listed
Apr 22, 2005Bard Access Systems, Inc
Intraoperative Ultrasound Cover Kit
Terminated
ITXNone listed
Apr 22, 2005Bard Access Systems, Inc
Site-Rite Sterile Ultrasound Probe Cover with Gel
Terminated
ITXNone listed
Apr 22, 2005Bard Access Systems, Inc
Site-Rite Sterile Needle Guide Kit - 21 Gauge
Terminated
ITXNone listed
Apr 22, 2005Bard Access Systems, Inc
Site-Rite Sterile Needle Guide Kit - 20 gauge
Terminated
ITXNone listed
Apr 22, 2005Bard Access Systems, Inc
Site-Rite Sterile Needle Guide Kit - 18 gauge
Terminated
ITXNone listed
Jul 20, 2004Hitachi 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
ITXK013723

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