SECTRA IDS5 RADIOLOGY WORKSTATION VERSION 10.1— 510(k) K033088

Substantially Equivalent

Sectra AB

FDA 510(k) clearance K033088 for SECTRA IDS5 RADIOLOGY WORKSTATION VERSION 10.1, Substantially Equivalent on 2003-10-29. Applicant: Sectra AB.

Clearance details

Applicant: Sectra AB
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2003-09-29
Decision date: 2003-10-29
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.