Accuro 3S— 510(k) K253452
Substantially EquivalentRivanna Medical, Inc.
FDA 510(k) clearance K253452 for Accuro 3S, Substantially Equivalent on 2026-07-24. Applicant: Rivanna Medical, Inc.. Device class: 2.
Summary
Rivanna Medical's Accuro 3S is filed under IYO, pulsed echo ultrasonic imaging systems. The record doesn't give transducers or other specs.
Class II, 21 CFR 892.1560. Radiology is both the classification panel and the review panel. It came in as a Traditional 510(k).
Rivanna Medical filed from Charlottesville, Virginia. Review took 291 calendar days (October 6, 2025 to July 24, 2026).
Clearance details
- Applicant
- Rivanna Medical, Inc.
- Product code
- Product code IYO
- Device class
- Class 2
- Regulation
- 21 CFR 892.1560
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Charlottesville, VA, US
Recent devices under product code IYO
view allMore clearances from Rivanna Medical, Inc.
view allAdverse events under product code IYO
product code IYO- Malfunction
- 3,339
- Total
- 3,339
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.