K253310
- 510(k) number
- K253310
- Device name
- 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)
- Applicant
- Esaote, S.p.A. IT
- Product code
- IYN — System, Imaging, Pulsed Doppler, Ultrasonic
- Decision date
- 2025-11-25
- Date received
- 2025-09-29
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K253310.pdf
Official FDA record: K253310
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.