Accuro XV— 510(k) K254021
Substantially EquivalentRivanna Medical, Inc.
FDA 510(k) clearance K254021 for Accuro XV, Substantially Equivalent on 2026-04-09. Applicant: Rivanna Medical, Inc.. Device class: 2.
Summary
Accuro XV from Rivanna Medical is filed under IYO, pulsed echo ultrasonic imaging systems. The record doesn't describe the device or say what "XV" means.
Class II, 21 CFR 892.1560. The Radiology panel reviewed it as a Traditional 510(k).
Rivanna Medical filed from Charlottesville, Virginia. Review took 114 days (December 16, 2025 to April 9, 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.