510(k) Report

FDA applicant

Oncolog Medical QA AB

Uppsala, SE2 decisions2009–20090 recalls

FDA records 2 decisions for Oncolog Medical QA AB (Uppsala, SE) in 2009: 2 510(k) clearances. All are in product code IYE (Accelerator, Linear, Medical). Its devices cite 3 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Oncolog Medical QA AB’s devices, and how often a recall has named them.

FDA decisions per year

2in 2009

2009: 2
2009high 2 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Oncolog Medical QA AB by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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