eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R, eHertz S)— 510(k) K250228
Substantially EquivalentEsonic Technology (Wuhan) Co., Ltd.
FDA 510(k) clearance K250228 for eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R, eHertz S), Substantially Equivalent on 2025-04-23. Applicant: Esonic Technology (Wuhan) Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Esonic Technology (Wuhan) Co., Ltd.
- Product code
- Product code IYN
- Device class
- Class 2
- Regulation
- 21 CFR 892.1550
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wuhan, CN
Recent devices under product code IYN
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- K263182 — EVO X30 Diagnostic Ultrasound System +8 more
More clearances from Esonic Technology (Wuhan) Co., Ltd.
view allAdverse events under product code IYN
product code IYN- Death
- 25
- Injury
- 163
- Malfunction
- 1,538
- Other
- 4
- Total
- 1,730
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.