510(k) K961983— TRS 2000 TELERADIOLOGY SYSTEM

Substantially Equivalent

Sectra-Imtec AB

Clearance details

Applicant: Sectra-Imtec AB
Product code: Code LLZ
Advisory panel: Radiology
Date received: 1996-05-20
Decision date: 1996-08-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plano, TX, US

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.