Home › Device types › IYN
System, Imaging, Pulsed Doppler, Ultrasonic
FDA product code IYN · Class 2 · Radiology
5,056
Registered devices
2,748
Adverse events
300
Recalls
1,188
510(k) clearances
Devices with this code
Voluson — GE Ultrasound Korea Ltd.SonoScape — SONOSCAPE MEDICAL CORP.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.L31KP — FUJIFILM CORPORATIONHERA W9 Diagnostic Ultrasound System — SAMSUNG MEDISON CO., LTD.Power Park — FUJIFILM SONOSITE, INC.DC-80 PRO — Shenzhen Mindray Bio-Medical Electronics Co., Ltd.VC1-6T — Alpinion Medical Systems Co., Ltd.Transducer C5-1 — Philips Ultrasound LLCVivid — GE Vingmed Ultrasound A/SHERA Z20 — SAMSUNG MEDISON CO., LTD.UST-5419 — FUJIFILM CORPORATIONMyLab25 Gold — ESAOTE SPAMedisono — Medisono, LLCEUP-F334 — FUJIFILM CORPORATIONSonoSite Edge II — FUJIFILM SONOSITE, INC.Clarius Ultrasound Scanner — Clarius Mobile Health CorpEZU-PA5O-14 — FUJIFILM CORPORATIONUST-9102U-3.5 — FUJIFILM CORPORATIONLOGIQ — GE Ultrasound Korea Ltd.Medistim Interconnect Cable — Medistim ASA
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-09-24 | Philips Ultrasound, LLC | Ultrasound system may: 1) Not recognize previous transducer registration, prevent scanning, require re-registration with Wi-Fi/cellular access, which may be una |
| 2026-08-07 | Philips Ultrasound, LLC | Due to software issue with ultrasound system, doppler sample is displayed shallower than its actual measurement location, potentially causing inaccurate blood f |
| 2025-10-31 | Philips Ultrasound, LLC | Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining. |
| 2025-10-09 | B-K Medical A/S | GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement i |
| 2025-10-09 | B-K Medical A/S | GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement i |
| 2025-10-09 | B-K Medical A/S | GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement i |
| 2025-10-09 | B-K Medical A/S | GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement i |
| 2025-10-09 | B-K Medical A/S | GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement i |
| 2025-10-09 | B-K Medical A/S | GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement i |
| 2025-09-18 | GE Medical Systems, LLC | The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to i |
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