CHISON DIGITAL ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, TRANSVAGINAL MICRO-CONVEX PROBE, TRANSRECTAL LINEAR PROBE— 510(k) K112539

Substantially Equivalent

Leiker Regulatory & Quality Consulting

FDA 510(k) clearance K112539 for CHISON DIGITAL ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, TRANSVAGINAL MICRO-CONVEX PROBE, TRANSRECTAL LINEAR PROBE, Substantially Equivalent on 2012-01-30. Applicant: Leiker Regulatory & Quality Consulting.

Clearance details

Applicant: Leiker Regulatory & Quality Consulting
Product code: Code IYO
Advisory panel: Radiology
Date received: 2011-09-01
Decision date: 2012-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dublin, CA, US

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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.