SDL-300— 510(k) K854337

Substantially Equivalent

Shimadzu Corp.

FDA 510(k) clearance K854337 for SDL-300, Substantially Equivalent on 1986-06-20. Applicant: Shimadzu Corp..

Clearance details

Applicant: Shimadzu Corp.
Product code: Code ITX
Advisory panel: Radiology
Date received: 1985-10-28
Decision date: 1986-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kyoto City 604 Japan, JP

Download summary PDF View on FDA.gov ↗

Adverse events under product code ITX

product code ITX

Death: 6
Injury: 137
Malfunction: 2,036
Total: 2,179

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.