AIDA WITH DICOM AND HL7 INTERFACE— 510(k) K043324

Name: FDA 510(k) clearance K043324
Creator: U.S. Food and Drug Administration
Published: 2005-04-04

Substantially Equivalent

KARL STORZ Endoscopy-America, Inc.

FDA 510(k) clearance K043324 for AIDA WITH DICOM AND HL7 INTERFACE, Substantially Equivalent on 2005-04-04. Applicant: KARL STORZ Endoscopy-America, Inc.. Device class: 2.

Clearance details

Applicant: KARL STORZ Endoscopy-America, Inc.
Product code: Code FET
Device class: Class 2
Regulation: 21 CFR 876.1500
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

Download summary PDF View on FDA.gov ↗

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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.