K243479
- 510(k) number
- K243479
- Device name
- EchoGuide (Version 1)
- Applicant
- Sonavex, Inc. MD · US
- Product code
- IYO — System, Imaging, Pulsed Echo, Ultrasonic
- Decision date
- 2025-04-23
- Date received
- 2024-11-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K243479.pdf
Official FDA record: K243479
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.