MODIFICATION TO SECTRA IDS5 RADIOLOGY WORKSTATION - VERSION 10.1— 510(k) K033712

Substantially Equivalent

Sectra-Imtec AB

FDA 510(k) clearance K033712 for MODIFICATION TO SECTRA IDS5 RADIOLOGY WORKSTATION - VERSION 10.1, Substantially Equivalent on 2003-12-23. Applicant: Sectra-Imtec AB.

Clearance details

Applicant: Sectra-Imtec AB
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2003-11-26
Decision date: 2003-12-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Denton, TX, 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.