CONVEX PROBE, PVE-382M— 510(k) K855124

Substantially Equivalent

Toshiba Medical Systems

FDA 510(k) clearance K855124 for CONVEX PROBE, PVE-382M, Substantially Equivalent on 1986-03-12. Applicant: Toshiba Medical Systems.

Clearance details

Applicant: Toshiba Medical Systems
Product code: Code IYO
Advisory panel: Radiology
Date received: 1985-12-23
Decision date: 1986-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tustin, CA, 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.