Home › Device types › IYO
System, Imaging, Pulsed Echo, Ultrasonic
FDA product code IYO · Class 2 · Radiology
0
Registered devices
6,627
Adverse events
83
Recalls
895
510(k) clearances
Devices with this code
Voluson — GE Ultrasound Korea Ltd.SonoScape — SONOSCAPE MEDICAL CORP.eTRAX™ Needle — CIVCO MEDICAL INSTRUMENTS CO., INC.AcQMap — ACUTUS MEDICAL, INC.Diagnostic Ultrasound System — Shenzhen Mindray Bio-Medical Electronics Co., Ltd.EVIS-EUS IMAGE CABLE — OLYMPUS MEDICAL SYSTEMS CORP.Medistim VeriQCSystem — Medistim ASAHS40 — SAMSUNG MEDISON CO., LTD.Rollstand — Bard Access Systems, Inc.L31KP — FUJIFILM CORPORATIONClearWave — NEXT MEDICAL PRODUCTS, LLCCUBEscan — Mcube Technology Co.,LtdHERA W9 Diagnostic Ultrasound System — SAMSUNG MEDISON CO., LTD.Sonon — Healcerion Co., Ltd.Power Park — FUJIFILM SONOSITE, INC.VC1-6T — Alpinion Medical Systems Co., Ltd.Transducer C5-1 — Philips Ultrasound LLCVivid — GE Vingmed Ultrasound A/SPOLYSONIC — PARKER LABORATORIES INCHERA Z20 — SAMSUNG MEDISON CO., LTD.UST-5419 — FUJIFILM CORPORATIONMyLab25 Gold — ESAOTE SPAEUP-F334 — FUJIFILM CORPORATIONeTRAX™ Needle — CIVCO MEDICAL INSTRUMENTS CO., INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-06 | Volcano Corp | Software system may associate image data from one patient with another patient's record, potentially resulting in incorrect diagnosis or treatment. |
| 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 |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.