ITX · Transducer, Ultrasonic, Diagnostic
Radiology · 21 CFR 892.1570 · Class 2
Overview
| Product Code | ITX |
|---|---|
| Device Name | Transducer, Ultrasonic, Diagnostic |
| Regulation | 21 CFR 892.1570 |
| Device Class | Class 2 |
| Review Panel | Radiology |
| 3rd-Party Reviewable | Yes |
Identification
A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 409)
Showing 20 most recent of 409 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K250883 | ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R) | Olympus Medical Systems Corporation | Sep 18, 2025 | SESE |
| K250762 | ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R) | Olympus Medical Systems Corporation | Jul 11, 2025 | SESE |
| K250524 | Mendaera Guidance System | Mendaera, Inc. | Jul 2, 2025 | SESE |
| K250469 | Accuro® 3S Needle Guide Kit | Rivanna Medical, Inc. | Jun 13, 2025 | SESE |
| K241662 | Ultrasound Transducer Cover | Vitrolife Sweden AB | Aug 30, 2024 | SESE |
| K233965 | UltraDrape UGPIV Barrier and Securement (34-15) | Parker Laboratories, Inc. | Aug 15, 2024 | SESE |
| K241615 | Transducer Probe Cover | Hony Medical Co., Ltd. | Jul 3, 2024 | SESE |
| K233109 | TP Pivot Pro Needle Guide | Civco Medical Solutions | Dec 22, 2023 | SESE |
| K231666 | Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) | FUJIFILM Healthcare Americas Corporation | Dec 13, 2023 | SESE |
| K231783 | VitroPRO | CIVCO Medical Instruments Co., Inc. | Nov 14, 2023 | SESE |
| K223689 | Disposable Needle Guides and Grids | Advance Medical Designs, Inc. | Aug 2, 2023 | SESE |
| K222460 | Intraoperative Ultrasound Probe Cover | Exact Medical Manufacturing | May 12, 2023 | SESE |
| K221278 | Transducer Probe Cover | Hony Medical Co., Ltd. | Jan 11, 2023 | SESE |
| K222052 | VitroPRO | CIVCO Medical Instruments Co., Inc. | Nov 22, 2022 | SESE |
| K213087 | Natural Rubber Latex Ultrasound Transducer Probe Covers | Global Protection Corp. | Jun 7, 2022 | SESE |
| K211270 | CIV-Clear cover | CIVCO Medical Instruments Co., Inc. | Sep 13, 2021 | SESE |
| K211969 | EMM Ultrasonic Transducer Cover | Exact Medical Manufacturing | Aug 13, 2021 | SESE |
| K201425 | Disposable Intraoperative Probe (DIOP8) | Huntleigh Healthcare Limited | Feb 19, 2021 | SESE |
| K202035 | Vscan Air | GE Medical Systems Ultrasound and Primary Care Diagnostics | Nov 20, 2020 | SESE |
| K191491 | EZ-Cover | Medxpress.Pro | Jun 5, 2020 | SESE |
Top Applicants
- CIVCO Medical Instruments Co., Inc. — 14 clearances
- Biosound, Inc. — 13 clearances
- General Electric Co. — 11 clearances
- Acuson Corp. — 11 clearances
- Acuson Computed Sonography — 10 clearances
