ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/ MOZI-X1/ MOZI-X12/ DF-41E Diagnostic ultrasound system— 510(k) K261272
Substantially EquivalentEsonic Technology (Wuhan) Co., Ltd.
FDA 510(k) clearance K261272 for ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/ MOZI-X1/ MOZI-X12/ DF-41E Diagnostic ultrasound system, Substantially Equivalent on 2026-07-23. Applicant: Esonic Technology (Wuhan) Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Esonic Technology (Wuhan) Co., Ltd.
- Product code
- 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
view all- K261081 — Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)
- K260667 — Alturion Series Diagnostic Ultrasound System
- K260844 — ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound System
- K260748 — ES-Series
- K260123 — EPIQ Series Diagnostic Ultrasound System
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.