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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
DateFirm and productCodeLinked 510(k)
Mar 24, 2026Philips Ultrasound, Inc
Philips X7-2 Ultrasound Transducer
Open, Classified		 ITXK160807
K163120 +3
Mar 24, 2026Philips Ultrasound, Inc
Philips X3-1 Ultrasound Transducer
Open, Classified		 ITXK042540
Mar 24, 2026Philips Ultrasound, Inc
Philips S5-2 Ultrasound Transducer
Open, Classified		 ITXK081661
Mar 24, 2026Philips Ultrasound, Inc
Philips S4-1 Ultrasound Transducer
Open, Classified		 ITXK030455
K120321 +3
Mar 24, 2026Philips Ultrasound, Inc
Philips OMNI III TEE Ultrasound Transducer
Open, Classified		 ITXK043535
K081661
Mar 24, 2026Philips Ultrasound, Inc
Philips OMNI II TEE Ultrasound Transducer
Open, Classified		 ITXK014191
Mar 24, 2026Philips Ultrasound, Inc
Philips Mini Multi TEE Ultrasound Transducer
Open, Classified		 ITXK043535
K132304 +3
Mar 24, 2026Philips Ultrasound, Inc
Philips L17-5 Ultrasound Transducer
Open, Classified		 ITXK030455
Mar 24, 2026Philips Ultrasound, Inc
Philips L12-5 Ultrasound Transducer
Open, Classified		 ITXK030455
K043535 +3
Mar 24, 2026Philips Ultrasound, Inc
Philips C9-4 Ultrasound Transducer
Open, Classified		 ITXK030455
K043535
Mar 24, 2026Philips Ultrasound, Inc
Philips 3D6-2 Ultrasound Transducer
Open, Classified		 ITXK034003
K043535
Mar 3, 2026ESAOTE S.P.A.
Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038
Completed		 ITXK230179
Dec 31, 2025Sheathing Technologies Inc
Sheathes3D Seamless Viral Barrier, Latex-Free, 7/8"D Tapered to 2.9"W x 11.8"L (2.2cm Tapered to 7.4cm x 30cm), Non-Sterile, Ultrasound Probe Cover, Vaginal/Rectal, Tapered, Rolled, Extra-Long, Indivi
Open, Classified		 ITXK153212
Oct 3, 2025ImaCor Inc.
ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH.
Open, Classified		 ITXK220490
Aug 22, 2025Philips Ultrasound, Inc
SCNHD LA L7-4 HDI Transducer Probe
Open, Classified		 ITXK014182
Aug 22, 2025Philips Ultrasound, Inc
7.5MHZ Endo Transducer Probe
Open, Classified		 ITXK014191
K972348 +1
Jul 2, 2025Philips Ultrasound, Inc
Philips XL14-3 Transducer.
Open, Classified		 ITXK172607
K181485 +3
Jul 2, 2025Philips Ultrasound, Inc
Philips X8-2t Transducer.
Open, Classified		 ITXK163120
K172607 +2
Jul 2, 2025Philips Ultrasound, Inc
Philips X7-2t Transducer.
Open, Classified		 ITXK081802
K111513 +3
Jul 2, 2025Philips Ultrasound, Inc
Philips X6-1 Transducer.
Open, Classified		 ITXK132304
K160807 +3
Jul 2, 2025Philips Ultrasound, Inc
Philips X5-1 Transducer.
Open, Classified		 ITXK132304
K160807 +3
Jul 2, 2025Philips Ultrasound, Inc
Philips VL13-5 Transducer.
Open, Classified		 ITXK160807
K163120 +3
Jul 2, 2025Philips Ultrasound, Inc
Philips V6-2 Transducer.
Open, Classified		 ITXK062247
K081661 +3
Jul 2, 2025Philips Ultrasound, Inc
Philips S8-3t Transducer.
Open, Classified		 ITXK172607
K181485 +2
Jul 2, 2025Philips Ultrasound, Inc
Philips S7-3t Transducer.
Open, Classified		 ITXK043535
K132304 +3
Jul 2, 2025Philips Ultrasound, Inc
Philips S7-2 Transducer.
Open, Classified		 ITXK043535
K081661
Jul 2, 2025Philips Ultrasound, Inc
Philips S5-1 Transducer.
Open, Classified		 ITXK042540
K081802 +3
Jul 2, 2025Philips Ultrasound, Inc
Philips L9-3 Transducer.
Open, Classified		 ITXK030455
Jul 2, 2025Philips Ultrasound, Inc
Philips L8-4 Transducer.
Open, Classified		 ITXK030455
K043535
Jul 2, 2025Philips Ultrasound, Inc
Philips L12-4 Transducer.
Open, Classified		 ITXK120321
K153480 +3
Jul 2, 2025Philips Ultrasound, Inc
Philips L12-3 Transducer.
Open, Classified		 ITXK043535
K081661 +3
Jul 2, 2025Philips Ultrasound, Inc
Philips eL18-4 EMT Transducer.
Open, Classified		 ITXK172607
K181485 +2
Jul 2, 2025Philips Ultrasound, Inc
Philips eL18-4 Transducer.
Open, Classified		 ITXK172607
K181485 +2
Jul 2, 2025Philips Ultrasound, Inc
Philips C9-5EC Transducer.
Open, Classified		 ITXK030455
K043535
Jul 2, 2025Philips Ultrasound, Inc
Philips C5-2 Transducer.
Open, Classified		 ITXK030455
K043535 +3
Jul 2, 2025Philips Ultrasound, Inc
Philips C5-1 Transducer.
Open, Classified		 ITXK091804
K111513 +3
Jul 2, 2025Philips Ultrasound, Inc
Philips 3D9-3v Transducer.
Open, Classified		 ITXK043535
K081661 +3
May 30, 2025Civco Medical Instruments Co. Inc.
BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers
Open, Classified		 ITXK093713
Oct 25, 2024ImaCor Inc.
ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor ultrasound diagnostic platforms. Model/Catalog Number: CLT-010, CLT-010-1
Open, Classified		 ITXK080223
K100989 +2
Nov 17, 2023Aizu Olympus Co., Ltd.
Gastroscope-endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) and for endoscopic surgery within the upper digestive tract. Model Numbers: GF-UC140P-AL5, GF-UCT180, GF-UE160-AL5.
Open, Classified		 ITXK011314
K051541 +1
Sep 9, 2023Advance Medical Designs, Inc.
Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PC424, b) 20-PC448, c) 20-PC548, d) 20-PC596, e) 20-PC648
Open, Classified		 ITXNone listed
Sep 9, 2023Advance Medical Designs, Inc.
Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PMT03, b) 20PMT04
Open, Classified		 ITXNone listed
Sep 6, 2023Philips Ultrasound, Inc.
3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti 30, 50, and 70; ClearVue 850; HD15; iU22; and Compact 5000
Completed		 ITXK042540
K043535 +4
Dec 22, 2022GE Medical Systems, LLC
Vivid q N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult
Open, Classified		 ITXNone listed
Dec 22, 2022GE Medical Systems, LLC
Vivid i N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult C
Open, Classified		 ITXNone listed
Dec 22, 2022GE Medical Systems, LLC
Vivid q ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult a
Open, Classified		 ITXK082374
K092140 +2
Dec 22, 2022GE Medical Systems, LLC
Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374, K092140, K102388, K121062). Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pe
Open, Classified		 ITXK033139
K061525 +3
May 5, 2022Olympus Corporation of the Americas
Ultrasonic Gastrovideoscope, GF-UC140P-AL5. Intended for endoscopic real-time ultrasound imaging.
Open, Classified		 ITXK011314
Feb 11, 2022Huntleigh Healthcare Ltd.
HUNTLEIGH Disposable intraoperative Probe, 8Mhz (box), REF DIPP10, containing 10 individual Disposable Intraoperative Probes, REF DIOP8
Terminated		 ITXK201425
Nov 4, 2021Lumenis, Inc.
IPL Coupling Gel, I L (AX1009013), 12 pack of 0.25 L (AX1009018), 6 pack of 1 L (AX1009019 or AX1009063); and IPL Coupling Gel or EcoGel 200, 0.25 L (AX1009012) manufactured by Eco-Med Pharmaceutical
Terminated		 ITXK955246

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