MC125L-50 SHIMADZU MOBILE X-RAY SYSTEM— 510(k) K893637

Substantially Equivalent

Shimadzu Medical Systems

FDA 510(k) clearance K893637 for MC125L-50 SHIMADZU MOBILE X-RAY SYSTEM, Substantially Equivalent on 1989-07-20. Applicant: Shimadzu Medical Systems.

Clearance details

Applicant: Shimadzu Medical Systems
Product code: Code IZL
Advisory panel: Radiology
Date received: 1989-05-12
Decision date: 1989-07-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gardena, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code IZL

product code IZL

Other: 3
Total: 3

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.