K043324

Substantially Equivalent

AIDA WITH DICOM AND HL7 INTERFACE

Applicant: KARL STORZ Endoscopy-America, Inc.
Product code: FET
Advisory panel: Gastroenterology, Urology
Date received: 2004-12-02
Decision date: 2005-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Culver City, CA, US

Adverse events under product code FET

product code FET

Injury: 313
Malfunction: 54,276
Total: 54,589

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.