SECTRA IDS5 WORKSTATION— 510(k) K050196

Name: FDA 510(k) clearance K050196
Creator: U.S. Food and Drug Administration
Published: 2005-02-24

Substantially Equivalent

Sectra Imtec AB

FDA 510(k) clearance K050196 for SECTRA IDS5 WORKSTATION, Substantially Equivalent on 2005-02-24. Applicant: Sectra Imtec AB. Device class: 2.

Clearance details

Applicant: Sectra Imtec AB
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2005-01-27
Decision date: 2005-02-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Denton, TX, US

Download summary PDF View on FDA.gov ↗

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K063093 — SECTRA WORKSTATION, VERSION 11.12006-11-07
K051315 — MODIFICATION TO: SECTRA IDS5 WORKSTATION2005-06-15
K040376 — SECTRA IDS5 RADIOLOGY WORKSTATION; SECTRA MPR PACKAGE; SECTRA 3D PACKAGE2004-05-04

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.