MRX-865— 510(k) K921130

Substantially Equivalent

Mrx-Ray Tube Corp.

FDA 510(k) clearance K921130 for MRX-865, Substantially Equivalent on 1992-09-10. Applicant: Mrx-Ray Tube Corp..

Clearance details

Applicant: Mrx-Ray Tube Corp.
Product code: Code ITY
Advisory panel: Radiology
Date received: 1992-03-10
Decision date: 1992-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington, TX, US

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Adverse events under product code ITY

product code ITY

Other: 1
Total: 1

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.