MODEL IW17.5A INTRA OPERATIVE TRANSDUCER— 510(k) K904665

Substantially Equivalent

Kretztechnik AG

FDA 510(k) clearance K904665 for MODEL IW17.5A INTRA OPERATIVE TRANSDUCER, Substantially Equivalent on 1991-01-11. Applicant: Kretztechnik AG.

Clearance details

Applicant: Kretztechnik AG
Product code: Code ITX
Advisory panel: Radiology
Date received: 1990-10-15
Decision date: 1991-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austria, AT

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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.