MOBILE X-RAY SYSTEM— 510(k) K955036

Substantially Equivalent

Shimadzu Corp.

FDA 510(k) clearance K955036 for MOBILE X-RAY SYSTEM, Substantially Equivalent on 1995-12-22. Applicant: Shimadzu Corp..

Clearance details

Applicant: Shimadzu Corp.
Product code: Code IZL
Advisory panel: Radiology
Date received: 1995-11-03
Decision date: 1995-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kyoto City 604 Japan, JP

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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.