K253288
- 510(k) number
- K253288
- Device name
- 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)
- Applicant
- Esaote, S.p.A. IT
- Product code
- IYN — System, Imaging, Pulsed Doppler, Ultrasonic
- Decision date
- 2026-04-06
- Date received
- 2025-09-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K253288.pdf
Official FDA record: K253288
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.