ADDITIONAL TRANSDUCERS FOR USE W/SDL 300— 510(k) K897073

Substantially Equivalent

Shimadzu Corp.

FDA 510(k) clearance K897073 for ADDITIONAL TRANSDUCERS FOR USE W/SDL 300, Substantially Equivalent on 1990-08-21. Applicant: Shimadzu Corp..

Clearance details

Applicant: Shimadzu Corp.
Product code: Code ITX
Advisory panel: Radiology
Date received: 1989-12-22
Decision date: 1990-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gardena, CA, US

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.