Accuro 3S— 510(k) K243937

Substantially Equivalent

Rivanna Medical, Inc.

FDA 510(k) clearance K243937 for Accuro 3S, Substantially Equivalent on 2025-05-23. Applicant: Rivanna Medical, Inc..

Clearance details

Applicant: Rivanna Medical, Inc.
Product code: Code IYO
Advisory panel: Radiology
Date received: 2024-12-20
Decision date: 2025-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlottesville, VA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.