Product code ITX
- Device name
- Transducer, Ultrasonic, Diagnostic
- Medical specialty
- Radiology
- Device class
- 2
- Regulation number
- 892.1570
- Review panel
- RA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250883 | ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R) | Olympus Medical Systems Corporation | 2025-09-18 |
| K250762 | ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R) | Olympus Medical Systems Corporation | 2025-07-11 |
| K250524 | Mendaera Guidance System | Mendaera, Inc. | 2025-07-02 |
| K250469 | Accuro® 3S Needle Guide Kit | Rivanna Medical, Inc. | 2025-06-13 |
| K241662 | Ultrasound Transducer Cover | Vitrolife Sweden AB | 2024-08-30 |
| K233965 | UltraDrape UGPIV Barrier and Securement (34-15) | Parker Laboratories, Inc. | 2024-08-15 |
| K241615 | Transducer Probe Cover | Hony Medical Co., Ltd. | 2024-07-03 |
| K233109 | TP Pivot Pro™ Needle Guide | Civco Medical Solutions | 2023-12-22 |
| K231666 | Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) | FUJIFILM Healthcare Americas Corporation | 2023-12-13 |
| K231783 | VitroPRO | CIVCO Medical Instruments Co., Inc. | 2023-11-14 |
| K223689 | Disposable Needle Guides and Grids | Advance Medical Designs, Inc. | 2023-08-02 |
| K222460 | Intraoperative Ultrasound Probe Cover | Exact Medical Manufacturing | 2023-05-12 |
| K221278 | Transducer Probe Cover | Hony Medical Co., Ltd. | 2023-01-11 |
| K222052 | VitroPRO | CIVCO Medical Instruments Co., Inc. | 2022-11-22 |
| K213087 | Natural Rubber Latex Ultrasound Transducer Probe Covers | Global Protection Corp. | 2022-06-07 |
| K211270 | CIV-Clear cover | CIVCO Medical Instruments Co., Inc. | 2021-09-13 |
| K211969 | EMM Ultrasonic Transducer Cover | Exact Medical Manufacturing | 2021-08-13 |
| K201425 | Disposable Intraoperative Probe (DIOP8) | Huntleigh Healthcare Limited | 2021-02-19 |
| K202035 | Vscan Air | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2020-11-20 |
| K191491 | EZ-Cover | Medxpress.Pro | 2020-06-05 |
| K200733 | Opticross 35 15 MHz Peripheral Imaging Catheter | Boston Scientific Corporation | 2020-04-17 |
| K190802 | Envision ultrasound pad and cover | Civco Medical Solutions | 2019-05-24 |
| K171272 | Cook-Swartz Doppler Flow Probe | Cook Incorporated | 2018-07-17 |
| K180970 | Disposable guides KDNG00 | Koelis | 2018-07-10 |
| K171040 | Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range | Koelis | 2017-07-31 |
| K163313 | ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe Reprocessor | CIVCO Medical Instruments Co., Inc. | 2017-06-09 |
| K170741 | GTK Disposable Needle Guides | Geotek Medikal Ltd Sti | 2017-06-01 |
| K171348 | Pinpoint GT Needle Guide Kits | C.R. Bard, Inc. | 2017-05-22 |
| K170338 | A-View | Stroke2prevent B.V. | 2017-05-16 |
| K163502 | iSR'obot Biopsy Kit | Biobot Surgical Pte., Ltd. | 2017-05-16 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00198953121382 | Voluson | GE Ultrasound Korea Ltd. | 2026-05-28 |
| 08033737713037 | THD Procto Software System | THD SPA | 2021-07-19 |
| 08056304450296 | MyLabSix CrystallLine | ESAOTE SPA | 2016-11-29 |
| 08056304450562 | MyLabTouch USA | Esaote Europe B.V. | 2016-09-27 |
| 08056304450555 | MyLabOne Vascular USA | Esaote Europe B.V. | 2016-09-27 |
| 08056304450548 | MyLabOne Musculoskeletal USA | Esaote Europe B.V. | 2016-09-27 |
| 08056304450531 | MyLabTouch | Esaote Europe B.V. | 2016-09-27 |
| 08056304450517 | MyLabOne reg. Anestesia USA | Esaote Europe B.V. | 2016-09-27 |
| 08056304450500 | MyLabOne Vascular | Esaote Europe B.V. | 2016-09-27 |
| 08056304450494 | MyLabOne Musculoskeletal | Esaote Europe B.V. | 2016-09-27 |
| 08056304450487 | MyLabSat | Esaote Europe B.V. | 2016-09-27 |
| 08056304450470 | MyLabOne reg. Anestesia | Esaote Europe B.V. | 2016-09-27 |
| 08056304450432 | MyLabSix | Esaote Europe B.V. | 2016-09-27 |
| 08056304450425 | MyLab40 Basic Unit | Esaote Europe B.V. | 2016-09-27 |
| 08056304450401 | MyLab20 Plus | Esaote Europe B.V. | 2016-09-27 |
| 08056304450395 | MyLab40 | Esaote Europe B.V. | 2016-09-27 |
| 08056304450388 | MyLab40 eHD | Esaote Europe B.V. | 2016-09-27 |
| 08056304450364 | MyLabGamma | ESAOTE SPA | 2016-09-27 |
| 08056304450340 | "MyLabSeven LCD 19""" | ESAOTE SPA | 2016-09-27 |
| 08056304450333 | MyLabSeven | ESAOTE SPA | 2016-09-27 |
| 08056304450319 | MyLabClass C | ESAOTE SPA | 2016-09-27 |
| 08056304450302 | MyLabClass C Advanced | ESAOTE SPA | 2016-09-27 |
| 08056304450241 | MyLabFive BASIC UNIT | Esaote Europe B.V. | 2016-09-27 |
| 08056304450227 | MyLabFive | Esaote Europe B.V. | 2016-09-27 |
| 08056304450067 | CA541 | ESAOTE SPA | 2016-09-27 |
| 08056304450050 | SL1543 | Esaote Europe B.V. | 2016-09-27 |
| 08056304450043 | MyLabSat USA | Esaote Europe B.V. | 2016-09-27 |
| 08056304450036 | IOT342 | ESAOTE SPA | 2016-09-27 |
| 08056304450012 | MyLabAlpha | ESAOTE SPA | 2016-09-27 |
| 08056304450005 | MyLabTwice | ESAOTE SPA | 2016-09-27 |