SHIMADZU IMAGE PROCESSOR DFS-500— 510(k) K905132

Substantially Equivalent

Shimadzu Medical Systems

FDA 510(k) clearance K905132 for SHIMADZU IMAGE PROCESSOR DFS-500, Substantially Equivalent on 1991-04-16. Applicant: Shimadzu Medical Systems.

Clearance details

Applicant: Shimadzu Medical Systems
Product code: Code LLZ
Advisory panel: Radiology
Date received: 1990-11-15
Decision date: 1991-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gardena, CA, US

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Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.