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) clearance K261272 · decided 2026-07-23
Clearance details
- K-number
- K261272
- 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.
- Decision
- Substantially Equivalent
- Date received
- 2026-04-17
- Decision date
- 2026-07-23
- Days to decision
- 97 days
- Clearance type
- Traditional
- Product code
- IYN
- Device class
- 2
- Regulation number
- 892.1550
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Wuhan, CN
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Esonic Technology (Wuhan) Co.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.