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ITX — Transducer, Ultrasonic, Diagnostic Class II

FDA Device Classification

Classification Details

Product Code
ITX
Device Class
Class II
Regulation Number
892.1570
Submission Type
Review Panel
RA
Medical Specialty
Radiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K250883olympus medical systems corporationULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R)September 18, 2025
K250762olympus medical systems corporationULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20July 11, 2025
K250524mendaeraMendaera Guidance SystemJuly 2, 2025
K250469rivanna medicalAccuro® 3S Needle Guide KitJune 13, 2025
K241662vitrolife swedenUltrasound Transducer CoverAugust 30, 2024
K233965parker laboratoriesUltraDrape UGPIV Barrier and Securement (34-15)August 15, 2024
K241615hony medical coTransducer Probe CoverJuly 3, 2024
K233109civco medical solutionsTP Pivot Pro™ Needle GuideDecember 22, 2023
K231666fujifilm healthcare americas corporationEndoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)December 13, 2023
K231783civco medical instruments coVitroPRONovember 14, 2023
K223689advance medical designsDisposable Needle Guides and GridsAugust 2, 2023
K222460exact medical manufacturingIntraoperative Ultrasound Probe CoverMay 12, 2023
K221278hony medical coTransducer Probe CoverJanuary 11, 2023
K222052civco medical instruments coVitroPRONovember 22, 2022
K213087global protectionNatural Rubber Latex Ultrasound Transducer Probe CoversJune 7, 2022
K211270civco medical instruments coCIV-Clear coverSeptember 13, 2021
K211969exact medical manufacturingEMM Ultrasonic Transducer CoverAugust 13, 2021
K201425huntleigh healthcare limitedDisposable Intraoperative Probe (DIOP8)February 19, 2021
K202035ge medical systems ultrasound and primary care diagnosticsVscan AirNovember 20, 2020
K191491medxpress.proEZ-CoverJune 5, 2020