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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

Company510(k)sRecalls
CIVCO Medical Instruments Co., Inc.1628
Philips Ultrasound, Inc.339
Exact Medical Manufacturing218
Biosound, Inc.130
Boston Scientific102
Siemens Medical Solutions USA, Inc.75
Acuson Corp.110
General Electric Co.110
Acuson Computed Sonography100
Toshiba America Medical Systems, In.C90
Decided510(k)Device and applicantCode
Sep 24, 2026K260114Align® Cover and Pad Guidance Tool
CIVCO Medical Instruments Co., Inc.
ITX
Aug 12, 2026K261170BA-004CC
Fujifilm Corporation, JP
ITX
Aug 10, 2026K254143EM-TECH Passive Ultrasound Probe Strap
EM-TECH Solutions, Inc.
ITX
Jul 30, 2026K260161SmartGuide Disposable Guides and Grids
UC-CARE , Ltd., IL
ITX
Jul 27, 2026K262474ND Needle Guidance System
Accurate Access, LLC
ITX
Jul 24, 2026K261014Accuro® 3S Needle Guide Kit
Rivanna Medical, Inc.
ITX
Sep 18, 2025K250883ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R)
Olympus Medical Systems Corporation, JP
ITX
Jul 11, 2025K250762ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R)
Olympus Medical Systems Corporation, JP
ITX
Jul 2, 2025K250524Mendaera Guidance System
Mendaera, Inc.
ITX
Jun 13, 2025K250469Accuro® 3S Needle Guide Kit
Rivanna Medical, Inc.
ITX
Aug 30, 2024K241662Ultrasound Transducer Cover
Vitrolife Sweden AB, SE
ITX
Aug 15, 2024K233965UltraDrape UGPIV Barrier and Securement (34-15)
Parker Laboratories, Inc.
ITX
Jul 3, 2024K241615Transducer Probe Cover
Hony Medical Co., Ltd., CN
ITX
Dec 22, 2023K233109TP Pivot Pro™ Needle Guide
Civco Medical Solutions
ITX
Dec 13, 2023K231666Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)
FUJIFILM Healthcare Americas Corporation
ITX
Nov 14, 2023K231783VitroPRO
CIVCO Medical Instruments Co., Inc.
ITX
Aug 2, 2023K223689Disposable Needle Guides and Grids
Advance Medical Designs, Inc.
ITX
May 12, 2023K222460Intraoperative Ultrasound Probe Cover
Exact Medical Manufacturing, CN
ITX
Jan 11, 2023K221278Transducer Probe Cover
Hony Medical Co., Ltd., CN
ITX
Nov 22, 2022K222052VitroPRO
CIVCO Medical Instruments Co., Inc.
ITX
Jun 7, 2022K213087Natural Rubber Latex Ultrasound Transducer Probe Covers
Global Protection Corp.
ITX
Sep 13, 2021K211270CIV-Clear cover
CIVCO Medical Instruments Co., Inc.
ITX
Aug 13, 2021K211969EMM Ultrasonic Transducer Cover
Exact Medical Manufacturing
ITX
Feb 19, 2021K201425Disposable Intraoperative Probe (DIOP8)
Huntleigh Healthcare Limited, GB
ITX
Nov 20, 2020K202035Vscan Air
GE Medical Systems Ultrasound and Primary Care Diagnostics
ITX
Jun 5, 2020K191491EZ-Cover
Medxpress.Pro, BE
ITX
Apr 17, 2020K200733Opticross 35 15 MHz Peripheral Imaging Catheter
Boston Scientific Corporation
ITX
May 24, 2019K190802Envision ultrasound pad and cover
Civco Medical Solutions
ITX
Jul 17, 2018K171272Cook-Swartz Doppler Flow Probe
Cook Incorporated
ITX
Jul 10, 2018K180970Disposable guides KDNG00
Koelis, FR
ITX
Jul 31, 2017K171040Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range
Koelis, FR
ITX
Jun 9, 2017K163313ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe Reprocessor
CIVCO Medical Instruments Co., Inc.
ITX
Jun 1, 2017K170741GTK Disposable Needle Guides
Geotek Medikal Ltd Sti, TR
ITX
May 22, 2017K171348Pinpoint GT Needle Guide Kits
C.R. Bard, Inc.
ITX
May 16, 2017K170338A-View
Stroke2prevent B.V., NL
ITX
May 16, 2017K163502iSR'obot Biopsy Kit
Biobot Surgical Pte., Ltd., SG
ITX
Aug 17, 2016K152126UST-5550-R; UST-5536-R; L43K
Hitachi Aloka Medical America, Inc.
ITX
Aug 5, 2016K160806Verza Guidance System
CIVCO Medical Instruments Co., Inc.
ITX
Aug 1, 2016K160414Precision Point Biopsy Needle Guide
Corbin Clinical Resources, LLC
ITX
Mar 4, 2016K153212Sheathes Ultrasound Probe Covers
Sheathing Technologies, Inc.
ITX
Sep 22, 2015K152403Permanent Sled Bag
Boston Scientific
ITX
Oct 16, 2014K142618Intra-operative Ultrasound Transducer, PROSOUND ALPHA 7 Diagnostic Ultrasound System, ARIETTA 70 Diagnostic Ultrasound S
Hitachi Aloka Medical America, Inc.
ITX
Jul 11, 2014K141334REUSABLE GUIDE
Koelis, FR
ITX
Jun 11, 2014K140854INTRA-OPERATIVE ULTRASOUND TRANSDUCER
Hitachi Aloka Medical, Ltd.
ITX
May 15, 2014K1410936VT-D ULTRASOUND TRANSDUCER
Ge Vingmed Ultrasound AS, NO
ITX
Sep 17, 2013K131161EX3 STEPPER, CLASSIC STEPPER, MULTI-PURPOSE WORKSTATION STEPPER; MICRO-TOUCH, MICRO-TOUCH LP, MULIT-PURPOSE WORKSTATION,
CIVCO Medical Instruments Co., Inc.
ITX
Jun 11, 2013K131528NON-PYROGENIC ULTRASOUND TRANSDUCER COVER
CIVCO Medical Instruments Co., Inc.
ITX
Feb 20, 2013K123424MDU5 PLUS STERILE BAG
Boston Scientific Corp
ITX
Oct 5, 2012K122921C1-6-D ULTRASOUND TRANSDUCER
GE Healthcare
ITX
Sep 11, 2012K122515C2-9-D ULTRASOUND TRANSDUCER
GE Healthcare
ITX

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