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 |
|---|---|---|---|
| K260114 | Align® Cover and Pad Guidance Tool | CIVCO Medical Instruments Co., Inc. | 2026-09-24 |
| K261170 | BA-004CC | Fujifilm Corporation | 2026-08-12 |
| K254143 | EM-TECH Passive Ultrasound Probe Strap | EM-TECH Solutions, Inc. | 2026-08-10 |
| K260161 | SmartGuide Disposable Guides and Grids | UC-CARE , Ltd. | 2026-07-30 |
| K262474 | ND Needle Guidance System | Accurate Access, LLC | 2026-07-27 |
| K261014 | Accuro® 3S Needle Guide Kit | Rivanna Medical, Inc. | 2026-07-24 |
| 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 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00195278985613 | NA | GE Medical Systems (China) Co.,Ltd. | 2026-09-24 |
| 00198953126073 | Vivid | GE Vingmed Ultrasound A/S | 2026-09-21 |
| 00198953172384 | Vivid | GE Vingmed Ultrasound A/S | 2026-09-21 |
| 00198953172551 | Vivid | GE Vingmed Ultrasound A/S | 2026-09-21 |
| 00884838128101 | Affiniti 70 Diagnostic Ultrasound System | Philips Ultrasound LLC | 2026-09-18 |
| 00884838128125 | EPIQ Elite Diagnostic Ultrasound System | Philips Ultrasound LLC | 2026-09-18 |
| 00884838128118 | Affiniti 30 Diagnostic Ultrasound System | Philips Ultrasound LLC | 2026-09-18 |
| 00884838128095 | Affiniti 50 Diagnostic Ultrasound System | Philips Ultrasound LLC | 2026-09-18 |
| 04580826920769 | PENTAX Medical | PENTAX MEDICAL CORPORATION | 2026-08-25 |
| 04580826920721 | PENTAX Medical | PENTAX MEDICAL CORPORATION | 2026-08-25 |
| 03701104600420 | T-Lite | SONOSCANNER | 2026-08-25 |
| 00198953121382 | Voluson | GE Ultrasound Korea Ltd. | 2026-05-28 |
| 00198953113493 | LOGIQ | GE Ultrasound Korea Ltd. | 2026-01-21 |
| 00198953042779 | LOGIQ | GE Ultrasound Korea Ltd. | 2025-12-05 |
| 00198953042731 | LOGIQ | GE Ultrasound Korea Ltd. | 2025-12-05 |
| 00198953042748 | LOGIQ | GE Medical Systems, Ultrasound & Primary Care Diagnostics LLC | 2025-12-05 |
| 00198953042755 | LOGIQ | GE Ultrasound Korea Ltd. | 2025-12-05 |
| 00198953042816 | LOGIQ | GE Medical Systems, Ultrasound & Primary Care Diagnostics LLC | 2025-12-05 |
| 00198953042793 | LOGIQ | GE Ultrasound Korea Ltd. | 2025-12-05 |
| 00198953042762 | LOGIQ | GE Ultrasound Korea Ltd. | 2025-12-05 |
| 04953170410178 | EVIS EUS ULTRASOUND GASTROINTESTINAL VIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2025-11-19 |
| 00198953001400 | Venue | GE Medical Systems, Ultrasound & Primary Care Diagnostics LLC | 2025-11-17 |
| 10817929020357 | Sonata® System Software | Gynesonics, Inc. | 2020-02-21 |
| 00854763006126 | Acessa Table Top Field Generator | ACESSA HEALTH INC. | 2018-10-11 |
| 00854763006195 | Acessa ProVu Planar Field Generator (PFG) | ACESSA HEALTH INC. | 2018-10-11 |
| 00854763006249 | Acessa ProVu PFG Table Clamp | ACESSA HEALTH INC. | 2018-10-11 |
| 00841436106184 | Tracking Bracket Starter Kit | CIVCO MEDICAL INSTRUMENTS CO., INC. | 2017-08-22 |
| 00841436106191 | Tracking Bracket Starter Kit | CIVCO MEDICAL INSTRUMENTS CO., INC. | 2017-08-22 |
| 07540205000397 | Clarius Ultrasound Scanner | Clarius Mobile Health Corp | 2017-04-25 |
| 07540205000403 | Clarius Ultrasound Scanner | Clarius Mobile Health Corp | 2017-04-25 |