Home › Device types › ITX
Transducer, Ultrasonic, Diagnostic
FDA product code ITX · Class 2 · Radiology
8,904
Registered devices
4,104
Adverse events
147
Recalls
415
510(k) clearances
Devices with this code
Voluson — GE Ultrasound Korea Ltd.FUJIFILM — FUJIFILM CORPORATIONSonoScape — SONOSCAPE MEDICAL CORP.Bovie — ASPEN SURGICAL PRODUCTS, INC.AcQMap — ACUTUS MEDICAL, INC.Diagnostic Ultrasound System — Shenzhen Mindray Bio-Medical Electronics Co., Ltd.EVIS-EUS IMAGE CABLE — OLYMPUS MEDICAL SYSTEMS CORP.6C1 Transducer — SIEMENS MEDICAL SOLUTIONS USA, INC.Sheathes — SHEATHING TECHNOLOGIES, INC.HS40 — SAMSUNG MEDISON CO., LTD.Toshiba AccuSITE Bracket — CIVCO MEDICAL INSTRUMENTS CO., INC.8VC3 Transducer — SIEMENS MEDICAL SOLUTIONS USA, INC.L31KP — FUJIFILM CORPORATIONPinpoint GT Needle Guide Kit — Bard Access Systems, Inc.Cook-Swartz — Cook Vandergrift Inc.CUBEscan — Mcube Technology Co.,LtdHERA W9 Diagnostic Ultrasound System — SAMSUNG MEDISON CO., LTD.Power Park — FUJIFILM SONOSITE, INC.GTK Disposable Needle Guides — GEOTEK MEDIKAL VE SAGLIK HIZMETLERI TICARET SANAYI LIMITED SIRKETIVC1-6T — Alpinion Medical Systems Co., Ltd.Transducer C5-1 — Philips Ultrasound LLCVivid — GE Vingmed Ultrasound A/SHERA Z20 — SAMSUNG MEDISON CO., LTD.UST-5419 — FUJIFILM CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-17 | Sheathing Technologies Inc | Vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in contamination during use, posing an infection risk. |
| 2025-09-05 | Philips Ultrasound, Inc | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| 2025-09-05 | Philips Ultrasound, Inc | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| 2025-09-05 | Philips Ultrasound, Inc | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| 2025-09-05 | Philips Ultrasound, Inc | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| 2025-09-05 | Philips Ultrasound, Inc | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| 2025-09-05 | Philips Ultrasound, Inc | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| 2025-09-05 | Philips Ultrasound, Inc | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| 2025-09-05 | Philips Ultrasound, Inc | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| 2025-09-05 | Philips Ultrasound, Inc | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
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