DeviceClearance

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 Equivalent

Esonic 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.

Summary

Esonic Technology (Wuhan)'s clearance lists ten diagnostic ultrasound system names: ePascal S, SOR, S5, SA, SE, 80Elite, and 80, plus MOZI-X1, MOZI-X12, and DF-41E. They're filed under IYN, pulsed Doppler ultrasonic imaging systems.

Class II, 21 CFR 892.1550. Radiology is both the classification panel and the review panel, and it came in as a Traditional 510(k).

Esonic filed from Wuhan, China. The decision came 97 calendar days after FDA received it (April 17 to July 23, 2026).

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
Download summary PDFView on FDA.gov ↗

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More clearances from Esonic Technology (Wuhan) Co., Ltd.

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Adverse 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.