ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/ MOZI-X1/ MOZI-X12/ DF-41E Diagnostic ultrasound system

FDA 510(k) K261272 · Esonic Technology (Wuhan) Co., Ltd.

Substantially Equivalent

510(k) numberK261272

Submission

Device name
ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/ MOZI-X1/ MOZI-X12/ DF-41E Diagnostic ultrasound system
Applicant
Esonic Technology (Wuhan) Co., Ltd.
Wuhan, CN
Received
April 17, 2026
Decision date
July 23, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
IYN – System, Imaging, Pulsed Doppler, Ultrasonic
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1550
Specialty
Radiology

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Questions and answers

When was ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/ MOZI-X1/ MOZI-X12/ DF-41E Diagnostic ultrasound system cleared by the FDA?

ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/ MOZI-X1/ MOZI-X12/ DF-41E Diagnostic ultrasound system (K261272) received a 510(k) decision of Substantially Equivalent on July 23, 2026, 97 days after the submission was received.

What is the product code of K261272?

The FDA product code is IYN – System, Imaging, Pulsed Doppler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1550.