SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTION— 510(k) K080701

Substantially Equivalent

Shimadzu Corp.

FDA 510(k) clearance K080701 for SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTION, Substantially Equivalent on 2008-05-14. Applicant: Shimadzu Corp..

Clearance details

Applicant: Shimadzu Corp.
Product code: Code IZL
Advisory panel: Radiology
Date received: 2008-03-11
Decision date: 2008-05-14
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Torrance, CA, US

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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.