K253452
- 510(k) number
- K253452
- Device name
- Accuro 3S
- Applicant
- Rivanna Medical, Inc. VA · US
- Product code
- IYO — System, Imaging, Pulsed Echo, Ultrasonic
- Decision date
- 2026-07-24
- Date received
- 2025-10-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K253452.pdf
Official FDA record: K253452
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.