SMT-50CX/H— 510(k) K942669

Substantially Equivalent

Shimadzu Medical Systems

FDA 510(k) clearance K942669 for SMT-50CX/H, Substantially Equivalent on 1995-02-02. Applicant: Shimadzu Medical Systems.

Clearance details

Applicant: Shimadzu Medical Systems
Product code: Code LNH
Advisory panel: Radiology
Date received: 1994-06-06
Decision date: 1995-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Torrance, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LNH

product code LNH

Death: 11
Injury: 670
Malfunction: 1,460
Other: 2
Total: 2,143

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.