ITX
- Product code
- ITX
- Device name
- Transducer, Ultrasonic, Diagnostic
- Device class
- Class 2
- 21 CFR
- 21 CFR 892.1570
- Medical specialty
- Radiology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 15
- Summaries archived here
- 14 (direct download)
- 510(k) clearances (all years, FDA)
- 414 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (15)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261170 | 2026-08-12 | Fujifilm Corporation | BA-004CC | |
| K254143 | 2026-08-10 | EM-TECH Solutions, Inc. | EM-TECH Passive Ultrasound Probe Strap | |
| K260161 | 2026-07-30 | UC-CARE , Ltd. | SmartGuide Disposable Guides and Grids | |
| K262474 | 2026-07-27 | Accurate Access, LLC | ND Needle Guidance System | |
| K261014 | 2026-07-24 | Rivanna Medical, Inc. | Accuro® 3S Needle Guide Kit | |
| K250883 | 2025-09-18 | Olympus Medical Systems Corporation | ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-… | |
| K250762 | 2025-07-11 | Olympus Medical Systems Corporation | ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC… | |
| K250524 | 2025-07-02 | Mendaera, Inc. | Mendaera Guidance System | |
| K250469 | 2025-06-13 | Rivanna Medical, Inc. | Accuro® 3S Needle Guide Kit | |
| K241662 | 2024-08-30 | Vitrolife Sweden AB | Ultrasound Transducer Cover | |
| K233965 | 2024-08-15 | Parker Laboratories, Inc. | UltraDrape UGPIV Barrier and Securement (34-15) | |
| K241615 | 2024-07-03 | Hony Medical Co., Ltd. | Transducer Probe Cover | |
| K233109 | 2023-12-22 | Civco Medical Solutions | TP Pivot Pro Needle Guide | |
| K231666 | 2023-12-13 | FUJIFILM Healthcare Americas Corporati… | Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic … | |
| K231783 | 2023-11-14 | CIVCO Medical Instruments Co., Inc. | VitroPRO | FDA |
Official FDA classification page: ITX
Classification and pathway per current FDA publications. Data from openFDA (CC0).