DIGITAL IMAGING SYSTEM, MODELS DIGITREX-1000 AND DIGITREX-2000 (DIGITREX-X000 FAMILY)— 510(k) K982120

Substantially Equivalent

Trex Medical Corp.

FDA 510(k) clearance K982120 for DIGITAL IMAGING SYSTEM, MODELS DIGITREX-1000 AND DIGITREX-2000 (DIGITREX-X000 FAMILY), Substantially Equivalent on 1998-09-10. Applicant: Trex Medical Corp..

Clearance details

Applicant: Trex Medical Corp.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 1998-06-16
Decision date: 1998-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Broadview, IL, US

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Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.