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 |
|---|---|---|---|
| K261170 | fujifilm corporation | BA-004CC | August 12, 2026 |
| K254143 | em-tech solutions | EM-TECH Passive Ultrasound Probe Strap | August 10, 2026 |
| K260161 | uc-care | SmartGuide Disposable Guides and Grids | July 30, 2026 |
| K262474 | accurate access | ND Needle Guidance System | July 27, 2026 |
| K261014 | rivanna medical | Accuro® 3S Needle Guide Kit | July 24, 2026 |
| 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 |