Home › Device types › IYO
System, Imaging, Pulsed Echo, Ultrasonic
FDA product code IYO · Class 2 · Radiology
5,178
Registered devices
6,516
Adverse events
82
Recalls
894
510(k) clearances
Devices with this code
ArcScan Insight 100 — ARCSCAN, INC.HITACHI — HITACHI, LTD.Sonosite ST — FUJIFILM SONOSITE, INC.Battery — FUJIFILM SONOSITE, INC.SonoScape — SONOSCAPE MEDICAL CORP.Hisense — Qingdao Hisense Medical Co., Ltd.SonoScape — SONOSCAPE MEDICAL CORP.CLEARTRACK PACKAGE — SAMSUNG MEDISON CO., LTD.Hisense — Qingdao Hisense Medical Co., Ltd.EBit Series Diagnostic Ultrasound System — CHISON Medical Technologies Co., Ltd.Hub — ECHONOUS, INC.EPIQ 7 Diamond Select Ultrasound System — Philips Ultrasound LLCHITACHI — HITACHI, LTD.HITACHI — HITACHI, LTD.Sono dot AI — FCUTransducer C5-2 — Philips Ultrasound LLCSonoScape — SONOSCAPE MEDICAL CORP.LELTEK — LELTEK INC.Vivid — GE Medical Systems (China) Co.,Ltd.NA — GE Healthcare Austria GmbH & Co OGSonoScape — SONOSCAPE MEDICAL CORP.Sono Champion — FCUMedaSonics — Coopersurgical, Inc.HS30 Diagnostic Ultrasound System — SAMSUNG MEDISON CO., LTD.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-02 | Civco Medical Instruments Co. Inc. | There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be inc |
| 2026-03-02 | Civco Medical Instruments Co. Inc. | There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be inc |
| 2026-03-02 | Civco Medical Instruments Co. Inc. | There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be inc |
| 2026-03-02 | Civco Medical Instruments Co. Inc. | There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be inc |
| 2026-03-02 | Civco Medical Instruments Co. Inc. | There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be inc |
| 2026-03-02 | Civco Medical Instruments Co. Inc. | There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be inc |
| 2026-03-02 | Civco Medical Instruments Co. Inc. | There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be inc |
| 2026-03-02 | Civco Medical Instruments Co. Inc. | There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be inc |
| 2022-01-24 | Volcano Corp | Multi-Modality Touch Screen Modules (MM-TSM), which are bedside/secondary control units, used as part of Mobile IVUS systems, are missing the following labeling |
| 2021-11-04 | GE Healthcare, LLC | The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal |
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