L11, L12 LINEAR AND C11, C12 CONVEX ARRAY TRANSDUC— 510(k) K904901

Substantially Equivalent

Parexel Intl. Corp.

FDA 510(k) clearance K904901 for L11, L12 LINEAR AND C11, C12 CONVEX ARRAY TRANSDUC, Substantially Equivalent on 1991-03-26. Applicant: Parexel Intl. Corp..

Clearance details

Applicant: Parexel Intl. Corp.
Product code: Code ITX
Advisory panel: Radiology
Date received: 1990-10-30
Decision date: 1991-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, MS, US

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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.