ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/ MOZI-X1/ MOZI-X12/ DF-41E Diagn
Summary
Esonic Technology (Wuhan) Co., Ltd. received 510(k) clearance for ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/ MOZI-X1/ MOZI-X12/ DF-41E Diagnostic ultrasound system, a IYN device. Cleared on 2026-07-23.
Details
Source
510(k) Clearance
External ID
K261272
Action Date
2026-07-23
Status
Traditional
Category
device
Product Code
IYN
Product Description
ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/ MOZI-X1/ MOZI-X12/ DF-41E Diagnostic ultrasound system. Product code: IYN.
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 373 device clearances issued this month. Esonic Technology (Wuhan) Co., Ltd. has received 2 total clearances in our database.
Esonic Technology (Wuhan) Co., Ltd. has 2 FDA actions in our database, including 2 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Esonic Technology (Wuhan) Co., Ltd. have FDA actions?
Esonic Technology (Wuhan) Co., Ltd. has 2 FDA actions in our database, including 0 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K261272" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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