510(k) Report

FDA applicant

Koning Corporation

W Henrietta1 decision2015–20150 recalls

FDA records 1 decision for Koning Corporation (W Henrietta) in 2015: 1 original PMA approval. All are in product code OLQ (Cross-Sectional Mammographic Xray System). 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 Koning Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2015: 1
2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Koning Corporation by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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