ACCURO 3000 ULTRASOUND SCANNER— 510(k) K132736

Substantially Equivalent

Rivanna Medical, LLC

FDA 510(k) clearance K132736 for ACCURO 3000 ULTRASOUND SCANNER, Substantially Equivalent on 2014-03-11. Applicant: Rivanna Medical, LLC.

Clearance details

Applicant: Rivanna Medical, LLC
Product code: Code IYO
Advisory panel: Radiology
Date received: 2013-09-03
Decision date: 2014-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crozet, 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.