ITX — Transducer, Ultrasonic, Diagnostic Class II
FDA product code ITX covers "Transducer, Ultrasonic, Diagnostic", a Class II medical device regulated under 21 CFR 892.1570. Submissions are reviewed by the Radiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K250883 | olympus medical systems corporation | ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R) | September 18, 2025 |
| K250762 | olympus medical systems corporation | ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20 | July 11, 2025 |
| K250524 | mendaera | Mendaera Guidance System | July 2, 2025 |
| K250469 | rivanna medical | Accuro® 3S Needle Guide Kit | June 13, 2025 |
| K241662 | vitrolife sweden | Ultrasound Transducer Cover | August 30, 2024 |
| K233965 | parker laboratories | UltraDrape UGPIV Barrier and Securement (34-15) | August 15, 2024 |
| K241615 | hony medical co | Transducer Probe Cover | July 3, 2024 |
| K233109 | civco medical solutions | TP Pivot Pro Needle Guide | December 22, 2023 |
| K231666 | fujifilm healthcare americas corporation | Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) | December 13, 2023 |
| K231783 | civco medical instruments co | VitroPRO | November 14, 2023 |
| K223689 | advance medical designs | Disposable Needle Guides and Grids | August 2, 2023 |
| K222460 | exact medical manufacturing | Intraoperative Ultrasound Probe Cover | May 12, 2023 |
| K221278 | hony medical co | Transducer Probe Cover | January 11, 2023 |
| K222052 | civco medical instruments co | VitroPRO | November 22, 2022 |
| K213087 | global protection | Natural Rubber Latex Ultrasound Transducer Probe Covers | June 7, 2022 |
| K211270 | civco medical instruments co | CIV-Clear cover | September 13, 2021 |
| K211969 | exact medical manufacturing | EMM Ultrasonic Transducer Cover | August 13, 2021 |
| K201425 | huntleigh healthcare limited | Disposable Intraoperative Probe (DIOP8) | February 19, 2021 |
| K202035 | ge medical systems ultrasound and primary care diagnostics | Vscan Air | November 20, 2020 |
| K191491 | medxpress.pro | EZ-Cover | June 5, 2020 |