Home › Device types › IYN
System, Imaging, Pulsed Doppler, Ultrasonic
FDA product code IYN · Class 2 · Radiology
4,973
Registered devices
2,659
Adverse events
298
Recalls
1,181
510(k) clearances
Devices with this code
NA — MEDTRONIC XOMED, INC.N/A — MEDTRONIC SOFAMOR DANEK, INC.Consona AR Diagnostic Ultrasound System — Shenzhen Mindray Bio-Medical Electronics Co., 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.EPIQ 7 Diamond Select Ultrasound System — Philips Ultrasound LLCHITACHI — HITACHI, LTD.HITACHI — HITACHI, LTD.Transducer C5-2 — Philips Ultrasound LLCSonoScape — SONOSCAPE MEDICAL CORP.LELTEK — LELTEK INC.Norland at Swissray — LELTEK INC.Vivid — GE Medical Systems (China) Co.,Ltd.NA — GE Healthcare Austria GmbH & Co OGNA — MEDTRONIC XOMED, INC.SonoScape — SONOSCAPE MEDICAL CORP.HS30 Diagnostic Ultrasound System — SAMSUNG MEDISON CO., LTD.L44LA1 — FUJIFILM CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 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 |
| 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 |
| 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 |
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.