K243253
- 510(k) number
- K243253
- Device name
- 6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)
- Applicant
- Esaote, S.p.A. IT
- Product code
- IYN — System, Imaging, Pulsed Doppler, Ultrasonic
- Decision date
- 2025-06-18
- Date received
- 2024-10-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K243253.pdf
Official FDA record: K243253
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.