ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM— 510(k) K970508

Substantially Equivalent

Shimadzu Medical Systems

FDA 510(k) clearance K970508 for ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, Substantially Equivalent on 1997-08-04. Applicant: Shimadzu Medical Systems.

Clearance details

Applicant: Shimadzu Medical Systems
Product code: Code IYO
Advisory panel: Radiology
Date received: 1997-02-10
Decision date: 1997-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Torrance, 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.